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To
The Chairman,
Institute Ethics Committee
Central Institute of Psychiatry,
Kanke, Ranchi, Jharkhand - 834006

Subject: Request for Institute Ethics Committee Approval

Requested Sir/Madam,
I, Dr Mrinmoy Sarkar, currently pursuing post-graduation in MD course,
session 2022-25, state that I have received accepted research protocol for my thesis,
titled “Efficacy of Gamma-tACS on cognition and craving in Alcohol Use Disorder: A
Sham Controlled Study”, under the guidance of Dr. Alok Pratap, Associate Professor
of Psychiatry, CIP. I, therefore, request you to grant me approval for the same.

Thanking you,

Yours sincerely,

Dr. Mrinmoy Sarkar

MD Psychiatry
Session 2022-25

GOVERNMENT OF INDIA
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CENTRAL INSTITUTE OF PSYCHIATRY

RANCHI-834006

UNDERTAKING BY INSTITUTE SCHOLAR FOR OWNERSHIP OF RESEARCH ACTIVITY/IES

I Dr Mrinmoy Sarkar, son of Archana Sarkar resident of 27/4/10 KUMAR DURGANATH LANE,P.O.-
KHAGRA,DISTRICT-MURSHIDABAD,PIN-742103,WEST BENGAL a candidate admitted to the `MD
PSYCHIATRY’ Programme of the Institute for the Session 2022-2025hereby undertake that:
 I shall be governed by disciplinary regulations of the institute where I have to pursue my
doctoral/post-doctoral research work.
 I shall devote adequate time to research during the tenure of the course except as provided in
the rules.
 I shall obtain the approval of the Institute Ethics Committee and register my research work
under appropriate registries before commencing my work during the tenure of my course.
 I shall prepare the progress report of my doctoral/post-doctoral research work of at the end
of each academic year and communicate it to the Institute Ethics Committee through the
Guide/Supervisor/Faculty Member before the end of the term/year.
 I will use the internet facility provided by the Institute for Academic/Research purposes only. I
will never misuse it for any other purposes.
 I will abide by the Anti-Plagiarism Policy adopted by the Institute from time to time.
 That the research activities undertaken by me during the tenure of my course shall be strictly
governed by the rules and regulations of the Institute and University.
 The Institute reserves the rights of storing and/or sharing the part/whole of the
published/unpublished data of my research work for a maximum period of five years from the
completion of my course tenure. However, I agree that Institute can share the data within the
academic premises of the Institute for its students and scholars at all times.
 Copyright and ownership of the research work to be conducted as part of the academic
course would be jointly owned by the scholar and guide/joint guide/co-guide/faculty/s under
the broad umbrella of the Institute. Each party would acknowledge/include the other party
with due respect/integrity in dissemination/publication/distribution of the data related to my
research work at all times.

Signature:
Signature:
Name:
Date:
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GOVERNMENT OF INDIA
CENTRAL INSTITUTE OF PSYCHIATRY
RANCHI, JHARKHAND

PROTOCOL FOR MD THESIS

SESSION 2022-2025

Efficacy of Gamma - tACS on Cognition and Craving in Alcohol Use Disorder:

A Sham Controlled Study

By
Dr Mrinmoy Sarkar

Under the guidance of

Dr ALOK PRATAP, M.D.
Associate Professor of Psychiatry
CIP Ranchi
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INTRODUCTION

Alcohol use is a significant public health issue, particularly in developing countries

like India. Alcohol is a potent drug that alters nearly all neurochemical systems both
acutely and chronically. According to the National Mental Health Survey of India
2015–16, 9% of adult men have alcohol use disorders (AUD). Chronic alcohol use
has been linked to personality disorders, risk-taking behaviours, and an increased
risk of suicide (Eashwar et al., 2020).
Craving can be defined as an acquired desire characterized by wanting to use the
drug in that moment. It is an important construct in addiction and included in the
DSM-5 as a clinical symptom of Substance Use Disorder (SUD). The concept of
alcohol craving also involves difficulties in regulating a strong desire or impulse to
drink alcohol (Verheul et al., 1999; Sinha et al., 2013). Attempts to quit are often
unsuccessful and the patient continues to use the substance despite knowledge of
physical and/or psychological harm (DSM-5, 2013; Daley et al., 2013) A major
problem jeopardizing recovery from alcoholism is high alcohol craving and the
chronic relapsing nature of the illness. Alcohol craving, the urge to use alcohol
(Martinotti et al., 2013), is viewed as a highly challenging obstacle for recovery from
dependency (Lowman et al., 2000).
Cognition is the internal representation, maintenance and updating of information for
the purpose of exerting control over thoughts and behaviours (Braver et al., 2001)
Studies have shown significant cognitive deficits in individuals with alcohol
dependence mainly in executive functions, working memory and high impulsiveness.
Excessive alcohol intake over time is linked to cognitive problems, including memory
loss. Excessive alcohol use has been linked to significant cognitive deficits that can
last even after the person stops drinking (Vijay P et al., 2022).
In substance use research, it has been theorized that deficits in executive
functioning contribute to substance use problems as a result of poor cognitive
regulation of behaviour (Giancola et al., 2003).
Preclinical and clinical studies have linked AUD with abnormal functioning of
dopaminergic tracts of the mesocorticolimbic pathway, which includes the ventral
tegmental area (VTA), striatum, nucleus accumbens (NAcc), and prefrontal cortex
(Wilson, 2015). Indeed, studies employing Positron Emission Tomography (PET)
report decreased ventral striatal D2 receptor binding and reduced dopamine release
in patients with AUD. Further, the downregulation of these receptors correlate with
lifetime alcohol use as well as relapse risk (Heinz et al., 2009). Besides the dopamine
deficiency hypothesis, AUD is also characterized by structural and functional
alterations within prefrontal regions, including the dorsolateral prefrontal cortex
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(DLPFC). The Dorso Lateral Prefrontal Cortex (DLPFC) governs higher order
cognitive functions that modulate goal directed and self-regulation behaviours
(Koob et al., 2016). In patients with AUD, reduced DLPFC functioning correlates with
impaired performance on cognitive tasks, including tests evaluating inhibitory
control and reinforcement learning (Li et al.,2009; Park et al., 2010). Enhancing
DLPFC activity may reduce alcohol craving through two neural mechanisms. First,
increased DLPFC activity leads to increased dopamine release in mesolimbic
structures including the caudate nucleus (Strafella et al., 2010), which may
remediate the dopamine dysfunction present in AUD. Second, the DLPFC has been
strongly implicated in inhibitory control of drug seeking behaviours.
Transcranial alternating current stimulation (tACS) is a form of non-invasive brain
stimulation that modulates neural oscillations in humans by application of weak
electric current to the scalp. The underlying neurobiological mechanism of tACS is
the remarkable susceptibility of neural oscillations to low-amplitude rhythmic electric
fields. The oscillation modulation by tACS enhances information transfer throughout
anatomically and functionally connected regions, in turn, improving cognitive
processes. Abnormalities in brain oscillations are known to underlie the
pathogenesis of neuropsychiatric disorders. It is hypothesized that if sinusoidal
current is applied externally, it can increase or decrease the power of endogenous
oscillatory rhythms in the brain and can potentially rectify the abnormalities in brain
oscillations. The mechanistic basis of HD-tACS might involve synchronization or
desynchronization of the peak oscillatory activity in the neuronal networks. This is
called neuronal entrainment (Sreeraj et al., 2019). It has been postulated that rather
than shifting the peak frequency and phase of oscillations, it is the matching of
external frequency with the endogenous activity which brings the effect of HD-tACS.
Different rhythms occur simultaneously in the brain and are known to modulate each
other. Hence, the effects might not be simple and unidirectional, as the targeted
oscillations can further modulate oscillations of other frequencies, which could
mediate the functional changes (Reato et al., 2013).
Treatment with 40 Hz tACS treatment was safe and showed preliminary efficacy in a
small open label pilot study with six patients suffering from AUD.
Although pharmacologic treatments with Naltrexone, Topiramate and Acamprosate
for alcohol dependence in primary care and specialty medical setting alone and in
combination with brief or more extensive psychosocial therapies are available, these
have often only modest or controversial effects (Assanangkornchai & Srisurapanont,
2007; Miller et al., 2011; Fox et al., 2007; Breese et al., 2011). One of the main
reasons is that these patients are not ready to stop drinking, and thus are not
attracted to the goals proposed by the current psychosocial and pharmacological
treatment. As substance addiction is not the result of any one single neurologic or
anatomical defect, its treatment will require the input of multiple specialists working
in concert to maximize the efficacy of a given neuromodulatory therapy. Currently
extensive studies have been going on for TMS, tDCS and tACS in management of
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craving in Alcohol Use Disorder (AUD).

NEED FOR STUDY

Transcranial alternating current stimulation has advantages over other techniques of

non-invasive brain stimulation such as cost-effectiveness, small size of the
apparatus, allowing portability, and possibility of modulating neuronal activity. It is
hypothesized that the neuromodulatory effects of tACS may involve synchronization
in frontal and prefrontal brain regions, however, its mechanisms of action are still
unclear (Alexander et al., 2019). In alcohol-dependent persons or persons at high risk,
frontal and parietal gamma activity was found to be reduced during cognitive tasks
(Padmanabhapillai et al., 2006; Porjesz et al., 2003). This reduced gamma power
leads to altered brain connectivity in persons with chronic alcohol consumption and
is likely to attribute to the impaired cognitive function in severe AUD (Ramlakhan et
al., 2021), whereas during alcohol withdrawal, gamma activity was found to be
increased, pointing to a hyperexcitability (Ahveninen et al., 2000).Therefore, tACS
entrainment or interference with endogenous EEG oscillations could also be used to
modulate disturbed cognitive function by rebalancing disturbed EEG patterns
(Vosskuhl et al., 2018)

A previous study has shown promising results on the feasibility and acceptability of
administering tACS at a community-based substance use treatment program and
alpha-tACS had a large and statistically significant effect on inhibitory control
compared to sham-tACS (Daughters et al., 2020).
There are ongoing studies of non-invasive modalities to reduce craving in alcohol
dependence. Gamma stimulation is relatively unexplored non-invasive intervention
which has been tested in schizophrenia, depression. Treatment with 40 Hz tACS
treatment was safe and showed preliminary efficacy in a small open label pilot study
with six patients suffering from AUD. Gamma tACS is a novel and promising Non-
Invasive Brain Stimulation technique in AUD and merits further investigation as it is
low cost, easy to use and nearly free of side effects. Randomized controlled trials
including neurobiological measures are needed for assessing its efficacy (Haller et
al., 2022).

AIM
To study the efficacy of Gamma Transcranial Alternating Current Stimulation of
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dorsolateral prefrontal cortex on the craving and cognition in patients with Alcohol
Use Disorder.

OBJECTIVE
1.To assess and compare severity of cognitive deficits in patients with alcohol use
disorder receiving active and sham Gamma tACS at baseline and on completion of
10 sessions.
2.To assess and compare severity of craving in patients with alcohol use disorder
receiving active and sham Gamma tACS at baseline and on completion of 10
sessions.
3.To see the correlation between post Gamma tACS changes in cognitive function
with changes in craving and with other socio-demographic variables.

NULL HYPOTHESIS

1.There will be no significant change in the severity of cognitive deficits in patients

with Alcohol Use Disorder receiving active and sham Gamma-tACS at baseline and
on completion of session.
2.There will be no significant change in severity of craving in patients with Alcohol
Use Disorder receiving active and sham Gamma-tACS at baseline and on completion
of 10 sessions.
3.There will be no significant correlation between post Gamma-tACS changes in
cognitive function with changes in craving and with other sociodemographic variable.

OUTCOME
Primary outcome: Improvement of cognitive deficits in patients with Alcohol Use
Disorder as response to Gamma-tACS.
Secondary outcome: Improvement of craving in patients with Alcohol Use Disorder
as response to Gamma-tACS.
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MATERIAL AND METHODS

Venue: Central Institute of Psychiatry, Ranchi.

Study Design: Prospective randomized sham controlled study
Sample size: Total of 40.
40 patients of Alcohol Use Disorder, 20 receiving active and 20 receiving sham
Gamma tACS who are matched for age, sex and education with the active group.
Sampling and Allocation Method: The patients would be sequentially randomly
assigned to groups (G1 receiving Real Stimulation and G2 receiving Sham
Stimulation) with a single random-number sequence. The numbers would be written
in a series of sealed envelopes. The envelope for each patient would be opened
immediately before the commencement of the first treatment session by the
clinician administering the Gamma tACS after the administration of the baseline
assessment. The patients and ratters (independent observer) would be blind to
treatment, but the clinician administering the Gamma tACS would be aware of the
treatment group.

INCLUSION CRITERIA FOR PATIENTS (G1 & G2)

1. Male patients diagnosed with Alcohol Dependence Syndrome as per International
Classification of Disease - 11th revision - Diagnostic Criteria for Research (WHO,
2022).
2. Male with Alcohol Dependence aged between 18 to 60 years.
3. Severity of Alcohol Dependence Questionnaire (SADQ) in Male with Alcohol
dependence greater than 16
4. The Clinical Institute Withdrawal Assessment for Alcohol (revised version) in Male
with Alcohol dependence CIWA-Ar lesser than 10.
5. Right-handed
6. Male with Alcohol dependence who give informed consent.
7. Patients will be screened for cognitive deficit with Montreal Cognitive Assessment
Test (MoCA). Cut off score is ≤25.

EXCLUSION CRITERIA FOR PATIENTS (G1 & G2)

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1. Male with Alcohol dependence having any other co-morbid substance dependence
except nicotine and caffeine.
2. Male with Alcohol dependence having any medical illness.
3. Male with Alcohol dependence having any other psychiatric illness, dementia,
psychotic disorder,
4. Male with Alcohol dependence who are on any psychotropic medication or any
anticraving medication in 2 weeks preceding and during the study.
5. Clinically diagnosed intellectual disability.
6. Past history of significant head injury.
7. Past history of epilepsy(Patients with history of alcohol withdrawal seizure will be
included).
8. HAMD Score ≥ 8.

TOOLS
1. Informed Consent and Patient Instruction Form.
2. Socio-demographic data and Clinical Data Sheet.
3. Handedness Preference Schedule (Mandal et al., 1992).
4. Severity of Alcohol Dependence Questionnaire (SADQ) (Stockwell et al 1983).
5. Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) (Sullivan JT et al
1989).
6. Montreal cognitive assessment (MoCA) (Nasreddine Z.S. et al.,2005)
7. Hamilton Depression Rating Scale - 17.
8. Hamilton rating scale for anxiety.
9. Gamma transcranial alternating current stimulation.
10. tACS side effect checklist (Eryılmaz et al, 2014)
11. N-Back test, Trail-Making Test, Berg’s Card Sorting Test of PEBL
Neuropsychological Test Battery.
12. Clinical Global Impression-Improvement (CGI-I) scale (Guy, W.,1976).
13. Alcohol craving questionnaire-short form-revised (ACQ-SF-R) (Singleton EG et
al.,1995)
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INFORMED CONSENT AND PATIENTS’ INSTRUCTION FORM

An informed consent will be taken from the patient and patient will be given
information about the whole study procedure and necessary instructions will be
given.

SOCIO-DEMOGRAPHIC AND CLINICAL DATA SHEET

A semi structured proforma for recording demographic details like age, sex, marital
status, religion, education, occupation, socio-economic status, habitat, and family
type as well as clinical data such as history of presenting illness, medical and
psychiatric illness and pre-morbid personality. It also includes details of physical
examination of all organ systems and complete mental status examination. Finally,
diagnosis of the patient according to the ICD 11 (DCR).

HANDEDNESS PREFERENCE SCHEDULE (Mandal et al., 1992)

Handedness preference schedule (Mandal et al., 1992) to assess handedness.
Sidedness Bias Schedule. Its Hindi version contains 15 items in a questionnaire
where subject is asked to indicate their hand preference for an activity on a 5-point
rating scale.

SEVERITY OF ALCOHOL DEPENDENCE QUESTIONNAIRE (SADQ)

(Stockwell et al., 1983)

It is a 20 items clinical screening tool designed to measure the presence and level of
alcohol dependence. Each item is scored on a 4-point scale, giving a possible range
of 0 to 60. A score of over 30 indicates severe alcohol dependence. Some local
clinical guidelines use the SADQ to predict the levels of medication needed during
alcohol detoxification.

THE CLINICAL INSTITUTE WITHDRAWAL ASSESSMENT FOR ALCOHOL,

CIWA-Ar (revised version) (Sullivan JT et al., 1989)
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It is a 10 item scale used in the assessment and management of alcohol withdrawal.

Each item on the scale is scored independently, and the summation of the scores
yields an aggregate value that correlates to the severity of alcohol withdrawal, with
ranges of scores designed to prompt specific management decisions such as the
administration of benzodiazepines (Sullivan et al., 1989).

Montreal Cognitive Assessment (MoCA) Test (Nasareddine et al., 2005)

MoCA is a brief bedside test. It assesses short-term memory, attention and working
memory, and executive functions. Scores on the MoCA range from 0-30 points. In
alcohol use disorder patients MoCA score of ≤ 25 is indicative of Mild cognitive
impairment.

Hamilton Depression Rating Scale (HDRS) (Hamilton., 1960)

The HDRS is the most widely used clinician-administered depression assessment

scale. The original version contains 17 items pertaining to symptoms of depression
experienced over the past week.

Alcohol Craving Questionnaire-short form revised (ACQ-SF-R) (Singleton

EG et al.,1995)
This specific rating instrument for assessment of craving consists in 12 questions
with proposed answers scoring from 1 to 7. Sum score of the 12 items indicates
craving severity, subgroups indicate the four factors ‘compulsivity, expectancy,
purposefulness, emotionality’.

HD-tACS Side Effect Checklist (Eryilmaz, S.B., et al., 2014)

This check list, developed by Eryilmaz and colleagues, consists of 13 side effects
categorically rated for the occurrence (from 0-none, 1-very mildly, 2-mildly, 3-
moderate, 4-severe, 5-very severe) during and after tACS. The items listed are
numbness at stimulation site, redness at stimulation site, itching at stimulation site,
burning at stimulation site, burning at stimulation site, pain at stimulation site,
nausea, fatigue, nervousness, insomnia, headache, difficulty in concentrating, acute
mood changes and changes in visual perception. Additionally, phosphenes
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occurrence was recorded in a dichotomous manner (absence or presence).

Gamma-tACS active:

Gamma frequency- tACS will be administered using a standard equipment (Starstim-

32,
Neuroelectrics BE, Spa.) using stringent safety measures. The electrodes will be
placed at the
left DLPFC (F3) and the right DLPFC (F4) according to 10-20 system. 10 once- daily
20 min HD-Gamma (40Hz) tACS sessions will be administered on 5 consecutive
days in a week for two consecutive weeks using standard equipment. Stimulation
parameters were set to a current of 2 mA (amplitude -1 mA to +1 mA, peak-to-peak)
at 40 Hz The Strastim 32 is a wearable device that wirelessly transmits the 32-
channel data via wifi. Its hybrid electrodes can be used for electrical stimulation
tACS. It synchronized multi-focal target stimulation of specific brain networks. It has
20-30 channels with stimulation sampling rate of 1000 SPS and stimulation
frequency range of 0-250 hz (tACS); 0-500 (tRNS) where Data transmission will be
wireless (wi-fi network) or wired (USB cable).

Gamma-tACS sham

2 mA current will be applied for 30 sec in the exact location as stated in active
process giving
an initial sensation of tACS while minimizing stimulatory effects.

NEURO-PSYCHOLOGICAL TESTS FROM PEBL

PEBL (Psychology experiment building language) is a free, open-source software

system that allows researchers and clinicians to design, run, and share behavioural
tests. It provides a library of functions for general computing as well as ones
devoted to the design of experiments.

PEBL Dual N-Back test

In n-back task, participants are presented with a sequence of stimuli (e.g., Letters)
one at a time and asked to compare the current stimulus to one presented n items
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prior in the sequence. When performing 2-back, the current stimulus is a target when
it matches the stimulus presented two stimuli ago. n-back test has traditionally been
used to assess working memory.

Trail Making Test

The Trail Making Test is a neuropsychological test of visual attention and switching.
It has two parts, in which the subject is instructed to connect a set of 25 dots as
quickly as possible while maintaining accuracy.

Berg’s Card Sorting Test (BCST)

This is PEBL’s version of the Wisconsin card sorting test. BCST measures executive
function. BCST consists of a 128 cards deck displayed on computer screen. Each
card contains a different combination of one of four shapes, colours and quantities.
Four key cards are displayed at the top of the screen as a guide to help determine
which of the four stacks the deck’s up card is sorted to. Berg’s procedures measure
executive function.

CLINICAL GLOBAL IMPRESSION – IMPROVEMENT (CGI-I) SCALE (Guy,

W., 1976)
CGI is clinician rated scale. CGI-I assesses the extent of clinical change in the patient
at the point of assessment compared with baseline and has a 7-point range, from
‘very much improved’-1 to ‘very much worse’-7.

PROCEDURE:

The study will be initiated after obtaining permission from the Institutional Ethics
Committee. The thesis will be registered with the Clinical Trial Registry of India (CTRI)
following the approval. All the participants (patients & controls) will be selected only
after explaining the study and obtaining their written informed consent.
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THE PATIENTS WHO MEET THE INCLUSION AND EXCLUSION CRITERIA WILL BE
CHOSEN

CONSENT WILL BE TAKEN AND CLINCAL DATA SHEET AND DEMOGRAPHIC DATA
FILLED.

HANDEDNESS ASSESSED.

SYMPTOM SEVERITY WILL BE ASSESSED AT BASELINE WITH ACQ-SF-R, CGI-I AND

COGNITIVE DEFICIT WILL BE ASSESSED WITH N-BACK TEST, BERG’S CARD
SORTING TEST, TRAIL MAKING TEST OF PEBL NEUROPSYCHOLOGY TEST
BATTERY.

ACTIVE GAMMA TACS AND SHAM GAMMA TACS TO PATIENTS WILL BE GIVEN
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FOR 5 CONSECUTIVE DAYS IN A WEEK FOR TWO CONSECUTIVE WEEKS FOR 20

MIN.

POST GAMMA tACS ASSESSMENT FOR SYMPTOM WITH ACQ-SF-R, CGI-I AND
COGNITION WITH N-BACK TEST, WORD FLUENCY TEST, TRAIL MAKING TEST OF
PEBL NEUROPSYCHOLOGY TEST BATTERY WILL BE REPEATED AT THE END OF 10
SESSIONS OF GAMM tACS.

POST PROCESSING OF DATA AND APPROPRIATE STATISTICAL ANALYSIS.

STATISTICAL PLAN

The data will be analysed using appropriate statistical method using SPSS for
windows (version 25.0, Chicago, IL). Socio-demographic and clinical variables will be
analysed using appropriate statistical tests like chi square/fisher exact test of
discrete variables. Continues variables will be analysed for test of normality and if
variables satisfy conditions of normality the parametric test like Student’s t-test
would be used for comparing both the groups and repeated measure ANOVA would
also be done. Other statistical tests will be used according to the requirement of this
study.

TIMELINE DISSERTATION
TIMELINE DISSERTATION

S. Activities Sub activities Months

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June June- Sept

No
- August august -Nov
July -May
1 Ethical
Committee
approval
2 Clinical Trial
Registry India
3 Data Patient enrollment
Collection
Baseline assessment for
symptom severity with ACQ-SF-
R, CGI-I and cognitive deficits
with N-BACK test, Berg’s card
sorting test, Trail making test of
PEBL Neuropsychology Test
Battery.
Computer generated
randomization

to Active and Sham groups

5 sessions/week(10 sessions
over 2week)

Post gamma-tACS
assessment for symptom
severity with ACQ-SF-R,CGI-I
and cognitive deficits with N
-BACK test, Berg’s card
sorting test, Trail making
test of PEBL
Neuropsychology Test
Battery at the end of 10
sessions of Gamma-tACS .
4 Data Analysis Compilation of results and
statistical analysis
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5 Writeup Preparation and submission of

report

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25. Ramlakhan, J. U., Ma, M., Zomorrodi, R., Blumberger, D. M., Noda, Y., & Barr, M. S.
(2020). The role of gamma oscillations in the pathophysiology of substance use
disorders. Journal of personalized medicine, 11(1), 17.
[Type here]

26. Reato, D., Rahman, A., Bikson, M., & Parra, L. C. (2013). Effects of weak
transcranial alternating current stimulation on brain activity—a review of known
mechanisms from animal studies. Frontiers in human neuroscience, 7, 687.
27. Sinha, R. (2013). The clinical neurobiology of drug craving. Current opinion in
neurobiology, 23(4), 649-654.
28. Strafella, A. P., Paus, T., Barrett, J., & Dagher, A. (2001). Repetitive transcranial
magnetic stimulation of the human prefrontal cortex induces dopamine release in
the caudate nucleus. The Journal of neuroscience, 21(15), RC157.
29. Singleton, E. G., Tiffany, S. T., & Henningfield, J. E. (1995). Development and
validation of a new questionnaire to assess craving for alcohol. NIDA Research
Monograph, 153, 289-289.
30. Sreeraj, V. S., Shivakumar, V., Sowmya, S., Bose, A., Nawani, H., Narayanaswamy,
J. C., & Venkatasubramanian, G. (2019). Online theta frequency transcranial
alternating current stimulation for cognitive remediation in schizophrenia: a case
report and review of literature. The Journal of ECT, 35(2), 139-143.
31. Sullivan, J. T., Sykora, K., Schneiderman, J., Naranjo, C. A., & Sellers, E. M. (1989).
Assessment of alcohol withdrawal: the revised clinical institute withdrawal assessment for
alcohol scale (CIWA‐Ar). British journal of addiction, 84(11), 1353-1357.

32. Vosskuhl, J., Strüber, D., & Herrmann, C. S. (2018). Non-invasive brain stimulation:
a paradigm shift in understanding brain oscillations. Frontiers in human
neuroscience, 12, 211.
33. Verheul, R., van den Brink, W., & Geerlings, P. E. T. E. R. (1999). A three-pathway
psychobiological model of craving for alcohol. Alcohol and Alcoholism (Oxford,
Oxfordshire), 34(2), 197-222.
34. Vijay, P., Khan, A., Sowmya, A. V., Chaudhury, S., Chaudhari, B., & Saldanha, D.
(2023). Cognitive deficits in alcohol dependence—A case–control analytical
study. Medical Journal of Dr. DY Patil University.
35. Wilson, S. J. (2015). The Wiley Handbook on the Cognitive Neuroscience of
Addiction.
36. World Health Organization. (1992). The ICD-10 classification of mental and
behavioural disorders: clinical descriptions and diagnostic guidelines. World Health
Organization.

APPENDIX-I
भारत सरकार
के य मना च क सा सं ान
राँची – 834006
[Type here]

सू चत सहम त प
प रयोजना का शीषक:
__________________________________________________________________________________

जांचकता

1. Dr Mrinmoy Sarkar, Junior resident-1, Central Institute of Psychiatry, Kanke, Ranchi

2. Dr Alok Pratap, M.D., Associate Professor of Psychiatry, Central Institute of Psychiatry, Kanke,
Ranchi.

तभागी
नाम: उ /ज म त थ:
अ भभावक का नाम: पता:
संभा वत न ध एजसी:
रोगी / अ भभावक / अ भभावक सहम त

भाग १: सूचना प रो गय / अ भभावक के लए

1. अ ययन का उ े य:आपसे उपयु अनुसधं ान अ ययन म भाग लेन े का अनुरोध कया जा रहा है। नामांकन से पहले, पढ़
सकते ह और न न जानकारी को समझते ह, हर समय आपको ऐसा करने क ज रत है!
अ ययन का उ े य वय क के ारं भक माता- पता क मृ यु और उनके जीवन क सम गुणव ा पर आवतक
अवसाद तता वकार के साथ वैव ा हक संतु क गुणव ा के भाव का आकलन करना है और इसक तुलना वैव ा हक
संतु के तर और इसके जीवन के अ त-गुणव ा पर भाव से करना है। आवत अवसाद तता वाले वय क म माता-
पता क मृ यु का अनुभव नह होता है।
2. अ ययन याएं: इस अ ययन के दौरान ओपीडी या अ ताल म भत रो गय म, व भ पैमाने के मा यम से व तृत
मू यांकन और मू यांकन के बाद डेटा को इक ा कया जाएगा और सां यक य प से मू यांकन कया जाएगा।
3. अ ययन का जो खम: शू य
4. अ ययन के लाभ: इस अ ययन से हम रो गय म मनोवै ा नक और मान सक ल ण का अ ययन करगे, जो तकसंगत
फामाकोथे रेपी और बेहतर बंधन म और मदद करगे।
5. ज टलताय: शू य
6. नुकसान भरपाई: शू य
7. गोपनीयता: आपक अ ययन क भागीदारी का रकॉड गोपनीय रखा जाएगा। डेटा का कोई भी काशन आपके नाम से
नह कया जाएगा। सहम त फॉम पर ह ता र करके , आप नयामक ा धकरण और सं ागत नै तक स म त को अपने
अ ययन से संबं धत च क सा रकॉड साझा करने का अ धकार दे ते ह।
8. तभा गय के अ धकार: आपको सी०आई०पी० म भ व य के उपचार से गुजरने के लए आपके या आपके प रवार के
अ धकार के कसी भी पूव ा ह के बना अ ययन के दौरान कसी भी समय अ ययन से बाहर नकलने का अ धकार है।
9. अ ययन म भागीदारी के वक प: आप अ ताल से सामा य प से इलाज जारी रख सकते ह।
अ ययन के दौरान या उसके बाद कसी भी समय, आप अ ययन के बारे म और जानकारी ा त कर
सकते ह.
[Type here]

भाग २: रोगी / अ भभावक / अ भभावक सहम त

मुझ े अ ययन को समझाया गया है और इस फॉम क साम ी पढ़ है । मुझ े पूछने और उ ह रखने का मौका दया गया है और म
इससे संतु ँ।

म अ ययन म दा खला लेने के लए तैयार ँ

रोगी का नाम:
रोगी / दे खभाल करने वाले का ह ता र/बाएँ अंगठू े का नशान:

दनांक:
रोगी के साथ संबधं :

जांचकता का बयान:
म, जाँचकता, _______________________________ने माता- पता / अ भभावक को उसी भाषा म समझाया
है, जसे वह समझते है। मने अ ययन क या, लाभ और हा न को समझा दया है ।

जांचकता का ह ता र: सा ी का ह ता र:
जांचकता का नाम: सा ी का नाम:
त थ: त थ:
[Type here]

GOVERNMENT OF INDIA
CENTRAL INSTITUTE OF PSYCHIATRY
RANCHI-834006

INFROMED CONSENT FORM

Efficacy of Gamma - tACS on Cognition and Craving in Alcohol Use Disorder:

A Sham Controlled Study

Investigators’ Details:
1. Dr Mrinmoy Sarkar
2. Dr Alok Pratap

Participant Details:
1. Name:
2. Age/Date of Birth:
3. Name of the Informant:
4. Address:

Patient/Spouse Consent Form

Part I: Information Sheet for Patient and/or Guardians/Caregivers

PURPOSE OF STUDY: You are requested to participate in the above-mentioned study.
You can read and understand this information before consenting for the study and
can read this information even after that all the times. Ensure that you understand
the information provided to you.
AIM OF THE STUDY To study the efficacy of Gamma Transcranial Alternating
Current Stimulation of dorsolateral prefrontal cortex on the craving and cognition in
patients with Alcohol Use Disorder.

OBJECTIVE OF THE STUDY

1.To assess and compare severity of cognitive deficits in patients with
alcohol use disorder receiving active and sham Gamma tACS at baseline and
on completion of 10 sessions.
2.To assess and compare severity of craving in patients with alcohol use
[Type here]

disorder receiving active and sham Gamma tACS at baseline and on

completion of 10 sessions.
3.To see the correlation between post Gamma tACS changes in cognitive
function with changes in craving and with other socio-demographic variables.

Process of Study: In this study, data would be collected by proper and detailed
evaluation of patients attending OPD of CIP as per the inclusion and exclusion
criteria mentioned and further the study would be analyzed to produce results.
1. Risk from the Study: Nil
2. Complications: Nil
3. Compensation: Nil
4. Confidentiality: Your participation in this study would be kept confidential. No
data/part of data would be published with your name in it. By signing this
consent from, you authorize investigative agency and Institute Ethics
Committee to share the records related to you.
5. Rights of the Participants: For receiving treatment at CIP, Ranchi in future, you
and your family has the right to withdraw your consent from the study during
any part of the study without any reason.
6. Benfits from the study:In this study we would assess effectiveness of Gamma
-tACS on cognition and craving in Alcohol Use Disorder that would help
develop and execute appropriate pharmacological and better management of
this patients.
7. Options for Participation in the Study: You can continue with the usual
treatment what you have been receiving from CIP, Ranchi.

You can ask for more/further information during and/or after the completion of
the study.
[Type here]

Part 2: Patient/Guardian/Caregiver Consent

I have read and have been explained the information contained in this form. I was given
chance to ask and put forth questions related to the study. I have been made satisfied
completely.

I hereby give my consent for participation in the Study.

Name of the Patient:

Signature/Left Thumb Impression of Patient/Caregiver:

Date:

Relationship with the patient:

Testimony of the Investigator:

I, Dr Mrinmoy Sarkar , Investigator have explained to the patient/caregiver in the
language in which they are conversant. I have explained the procedure, benefits and
harm of the study to them.

Signature of the Investigator: Signature of the Witness:

Name of the Investigator: Name of the Witness
Date: Date:
[Type here]

APPENDIX – 2

SOCIODEMOGRAPHIC DATA SHEET

Serial no: CRF no: Date:

Name: Father’s Name:

Address:

Age

Sex 1. Male 2. Female

Religion 1. Hindu 2. Muslim 3. Christian 4.others

Years of Education

Occupation 1. Employed 2. Unemployed

Economic status Monthly family income in rupees

Marital status 1. Married 2. Unmarried 3.Divorced\Separated

Family type 1. Nuclear 2. Joint

3. No. of family members

Habitat 1. Rural 2. Urban

[Type here]

APPENDIX-3

CLINICAL DATA SHEET

Age of onset of drinking (in
years)
Duration of drinking (in years)
Age of onset of dependence
(in years)
Duration of dependence (in
years)Course
Previous abstinence 1. Yes 2. No
No of abstinence in the past

Reason for re-starting drinking

Intake pattern
 Average intake
 Maximum intake
 Last intake
 Average amount spent
 Total income
Past history
1 past H/o withdrawal seizure
1. Yes 2.no
2. past H/o delirium tremens
1. Yes 2.no
.
3.past H/o alcohol /
substance dependence 1.Yes 2.no

4.Past h/o mental illness:

1.Yes 2.no
[Type here]

Family history
1. PSYCHIATRIC HISTORY: 1. Yes 2. No

2. MEDICAL HISTORY:
1. Yes 2. No
Personal history
1. PSYCHIATRIC 1. Yes 2. No
HISTORY:

2. MEDICAL HISTORY: 1. Yes 2. No

Physical examination: GENERAL SURVEY:

1. HEIGHT 2. WEIGHT 3.BMI
4.ABNORMALITIES

CARDIOVASCULAR SYSTEM:
1. PULSE: 2. BLOOD PRESSURE:
3.ABNORMALITIES

RESPIRATORY SYSTEM:
1. RESPIRATORY RATE:
2. ABNORMALITIES:

GASTRO-INTESTINAL SYSTEM:
1. ABNORMALITIES:
CENTRAL NERVOUS SYSTEM:
1. ABNORMALITIES :

FINAL IMPRESSION:
1.GROSSLY WNL 2.NOT WNL
Mental status examination General Appearance - 1. Normal 2. Abnormal
3. If abnormal, specify -

Attitude towards examiner 1. Cooperative 2. Uncooperative

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Motor activities 1. Increased 2. Decreased

3. Normal
Speech 1. Normal 2.Abnormal
3. If abnormal, specify -

Cognitive functions 1. WNL 2. Not WNL

Affect 1. Euphoric 2. Irritable
3. Euthymic 4. Others

Thought 1. NAD 2. Abnormal

3. If abnormal, specify -

Perception 1. NAD 2. Abnormal

3. If abnormal, specify -

Judgement 1. Intact 2. Impaired

Insight (grade)
Stage of Motivation:

APPENDIX-4
(HAND PREFERENCE SCHEDULE, HINDI VERSION)

कभीनह लगभग कभीकभी ब त.. हमेशा

1 2 3 4 5
[Type here]

दशा: कु छग त व धय न न ल खतवा यम दयाजाताहै.

कतनीबारआपइनग त व धय के दशनके लएअपनेसहीऔरबाएँहाथकाउपयोगकर?
चुनउपयु कोरहै कआपके लएद गईसारणीसेतदनुसारलागूऔर र ानकोभरने.
1. लेखनके लए, मअपनेबाएँहाथकाउपयोगकरनापसंदकरतेह ......................
औरदा हनेहाथका योगकरना....................
2. खानेके लए, मकरनेके लएअपनेदा हनेहाथका योगकरना ......................
औरबाएँहाथकाउपयोगकरना....................
3. एकबा ट पानीसेभराउठानेके लए, मअपनेबाएँहाथकाउपयोगकरनेके लएतरह ......................
औरदा हनेहाथका योगकरना....................
4. कुं जीपकड़जब कएकतालाखोलनेके लए, मअपनेबाएँहाथकाउपयोगकरनापसंदकरतेह ......................
औरदा हनेहाथका योगकरना....................
5. एकपकड़नेधारणकरनेके लए, मअपनेबाएँहाथकाउपयोगकरनाहै ......................
औरदा हनेहाथका योगकरना....................
6. एक शपकड़जब क च कलारंगभरनेके लए, मअपनेबाएँहाथकाउपयोगकरनेके लएतरह ......................
औरदा हनेहाथका योगकरना....................
7. एककं घीधारणकरते एमेरबे ाल मकं घीकरनेके लए, मअपनेदा हनेहाथका योगकरनाहै ......................
औरबाएँहाथकाउपयोगकरना....................
8. एकनालारखनेके लए, मअपनेबाएँहाथकाउपयोगकरनेके लएतरह ......................
औरदा हनेहाथका योगकरना....................
9. एकपानीके नलखोलनेके लए, मअपनेबाएँहाथकाउपयोगकरनापसंदकरतेह ......................
औरदा हनेहाथका योगकरना....................
10. एक बजलीके वचदबानेके लए, मकरनेके लएअपनेदा हनेहाथका योगकरना ......................
औरबाएँहाथकाउपयोगकरना....................
11. एकमैचछड़ीधारणकरते एमैच म काशके लए, मअपनेबाएँहाथकाउपयोगकरनेके लएतरह
...................... औरदा हनेहाथका योगकरना....................

12. जब कखेलखेलनेकाड वतरणके लए, मअपनेदा हनेहाथकाउपयोगकरनापसंदकरतेह ......................

औरबाएँहाथकाउपयोगकरना ....................
13. एकचाकू पकड़जब कस जय कोकाटनेके लए,
मअपनेबाएँहाथकाउपयोगकरनापसंदकरतेह ......................
औरदा हनेहाथका योगकरना ....................

14. एकरैकेटपकड़जब कबैड मटनखेलके लए, मअपनेदा हनेहाथकाउपयोगकरनापसंदकरतेह ......................

औरबाएँहाथकाउपयोगकरना ....................
[Type here]

15. एकबोतलक टोपीघूणनजब कइसेखोलनेके लए, मअपनेबाएँहाथकाउपयोगकरनेके लएतरह

...................... औरदा हनेहाथका योगकरना ....................

Total score: Left: Right:

Mandai, M. K., Pandey, G., Singh, S. K., & Asthana, H. S. (1992). Hand preference in

India. International Journal of Psychology, 27(6), 433-442.

APPENDIX-5

SEVERITY OF ALCOHOL DEPENDENCE QUESTIONAIRE (SADQ-C)

NAME__________________________________________AGE____________No.____
DATE:

Please recall a typical period of heavy drinking in the last 6 months.

When was this? Month:………………………………. Year……………………………..

Please answer all the following questions about your drinking by circling your most
appropriate response.

During that period of heavy drinking

1. After having just one or two drinks, I felt like having a few more.
ALMOST NEVER SOMETIMES OFTEN NEARLY ALWAYS

2*. After having two or three drinks, I could stop drinking if I had other things to do.
ALMOST NEVER SOMETIMES OFTEN NEARLY ALWAYS
[Type here]

3. When I started drinking alcohol, I found it hard to stop until I was fairly drunk.
ALMOST NEVER SOMETIMES OFTEN NEARLY ALWAYS

4. When I went drinking, I planned to have at least six drinks.

ALMOST NEVER SOMETIMES OFTEN NEARLY ALWAYS

5*. When I went drinking, I planned to have no more than two or three drinks.
ALMOST NEVER SOMETIMES OFTEN NEARLY ALWAYS

During that period of heavy drinking

1. The day after drinking alcohol, I woke up feeling sweaty.

ALMOST NEVER SOMETIMES OFTEN NEARLY ALWAYS

2. The day after drinking alcohol, my hands shook first thing in the morning.
ALMOST NEVER SOMETIMES OFTEN NEARLY ALWAYS

3. The day after drinking alcohol, my whole body shook violently first thing in the
morning if I didn't have a drink.
ALMOST NEVER SOMETIMES OFTEN NEARLY ALWAYS

4. The day after drinking alcohol, I woke up absolutely drenched in sweat.

ALMOST NEVER SOMETIMES OFTEN NEARLY ALWAYS

5. The day after drinking alcohol, I dread waking up in the morning.

ALMOST NEVER SOMETIMES OFTEN NEARLY ALWAYS

6. The day after drinking alcohol, I was frightened of meeting people first thing in the
morning.
ALMOST NEVER SOMETIMES OFTEN NEARLY ALWAYS

7. The day after drinking alcohol, I felt at the edge of despair when I awoke.
ALMOST NEVER SOMETIMES OFTEN NEARLY ALWAYS

8. The day after drinking alcohol, I felt very frightened when I awoke.
ALMOST NEVER SOMETIMES OFTEN NEARLY ALWAYS

9. The day after drinking alcohol, I liked to have an alcoholic drink in the morning.
ALMOST NEVER SOMETIMES OFTEN NEARLY ALWAYS

10. The day after drinking alcohol, I always gulped my first few alcoholic drinks down
as quickly as possible.
ALMOST NEVER SOMETIMES OFTEN NEARLY ALWAYS

11. The day after drinking alcohol, I drank more alcohol to get rid of the shakes.
ALMOST NEVER SOMETIMES OFTEN NEARLY ALWAYS

12. The day after drinking alcohol, I had a very strong craving for a drink when I
awoke.
[Type here]

ALMOST NEVER SOMETIMES OFTEN NEARLY ALWAYS

13. I drank more than a quarter of a bottle of spirits in a day (OR 1 bottle of wine OR
7
beers).
ALMOST NEVER SOMETIMES OFTEN NEARLY ALWAYS

14. I drank more than half a bottle of spirits per day (OR 2 bottles of wine OR 15
beers).
ALMOST NEVER SOMETIMES OFTEN NEARLY ALWAYS

15.I drank more than one bottle of spirits per day (OR 4 bottles of wine OR 30
beers).
ALMOST NEVER SOMETIMES OFTEN NEARLY ALWAYS

16.I drank more than two bottles of spirits per day (OR 8 bottles of wine OR 60
beers)
ALMOST NEVER SOMETIMES OFTEN NEARLY ALWAYS

Imagine the following situation:

1. You have been completely off drink for a few weeks

2. You then drink very heavily for two days

How would you feel the morning after those two days of drinking?

17.I would start to sweat.

NOT AT ALL SLIGHTLY MODERATELY QUITE A LOT

18. My hands would shake.

NOT AT ALL SLIGHTLY MODERATELY QUITE A LOT

19. My body would shake.

NOT AT ALL SLIGHTLY MODERATELY QUITE A LOT

20. I would be craving for a drink.

NOT AT ALL SLIGHTLY MODERATELY QUITE A LOT

SCORE
ALCOHOL DETOX PRESCRIBED: YES/NO

NOTES ON THE USE OF THE SADQ

The Severity of Alcohol Dependence Questionnaire was developed by the Addiction
Research Unit at the Maudsley Hospital. It is a measure of the severity of
[Type here]

dependence. The AUDIT questionnaire, by contrast, is used to assess whether or not

there is a problem with dependence.
The SADQ questions cover the following aspects of dependency syndrome:
· physical withdrawal symptoms

. affective withdrawal symptoms

· relief drinking

· frequency of alcohol consumption

· speed of onset of withdrawal symptoms.

Scoring

Answers to each question are rated on a four-point scale:

Almost never 0
Sometimes 1
Often 2
Nearly always 3
* Reverse Scored Items

 A score of 31 or higher indicates "severe alcohol dependence".

 A score of 16 -30 indicates "moderate dependence"

 A score of below 16 usually indicates only a mild physical dependency.

A chlordiazepoxide detoxification regime is usually indicated for someone who

scores 16 or over.

It is essential to take account of the amount of alcohol that the patient reports
drinking prior to admission as well as the result of the SADQ.
There is no correlation between the SADQ and such parameters as the MCV or GGT.

Stockwell, T., Murphy, D., & Hodgson, R. (1983). The severity of alcohol dependence
[Type here]

questionnaire: its use, reliability and validity. British journal of addiction, 78(2), 145-

155.

APPENDIX- 6

CLINICALINSTITUTEWITHDRAWALASSESSMENTOFALCOHOLSCALE,REVISED(
CIWA-Ar)
Patient: Date: Time: (24
hour clock,midnight=00:00)

Pulseorheartrate,takenforoneminute: Bloodpressure:_
NAUSEAANDVOMITING--
Ask"Doyoufeelsicktoyourstomach?Haveyouvomited?"Observation.

0nonauseaandnovomiting

1 mild nausea with no vomiting

23

4 intermittent nauseawith dryheaves

7constantnausea,frequentdryheavesandvomiting

TACTILEDISTURBANCES--Ask"Haveyouanyitching,pins andneedlessensations,
anyburning,anynumbness,ordoyoufeelbugs
crawlingonorunderyourskin?"Observation.

1 none

2 verymilditching,pinsand needles, burningornumbness

2milditching,pinsandneedles,burningornumbness
3moderateitching,pinsandneedles,burningornumbness

4 moderatelysevere hallucinations

5 severehallucinations

6 extremelyseverehallucinations
[Type here]

7continuoushallucinations
TREMOR--Armsextendedandfingersspreadapart.Observation.

0notremor

1 notvisible,butcanbefeltfingertiptofingertip

4moderate,withpatient'sarmsextended5

7severe,evenwitharmsnotextended AUDITORYDISTURBANCES--
Ask"Areyoumoreawareofsoundsaroundyou?Aretheyharsh?Dotheyfrighten you?
Are you hearing anything that is disturbing to you? Are you hearing things you
know are not there?"Observation.

1 notpresent

2 very mild harshness

or ability to frighten

3 mildharshness
orabilityto frighten
3moderateharshness
orabilitytofright en

4moderatelyseverehallucinations

5 severehallucinations

6 extremelyseverehallucinati ons

7continuoushallucinations
PAROXYSMAL SWEATS -- Observation.

0 nosweat visible

1barelyperceptiblesw
eating,palmsmo ist

4beadsofsweatobviousonforehead

7drenchingsweats

VISUALDISTURBANCES--
Ask"Doesthelightappeartobetoobright?Isitscolordifferent?Doesithurtyoureyes?
Are you seeing anything that is disturbing to you? Are you seeing things you
[Type here]

know are not there?"Observation. 0 notpresent

1
ve
ry
m
ild
se
ns
iti
vit
y

2mild sensitivity
3 moderatesensitivity

4 moderatelyseverehallucinations

5severehallucinations
6extremelyseverehallucinations

7continuoushallucinations

ANXIETY--Ask"Doyoufeelnervous?"Observation.

0 noanxiety, atease

1mildanxious

4moderatelyanxious,orguard
ed,soanxietyisinferr ed 5

7 equivalent to acute panic states as

seen in severe delirium
oracuteschizophrenicreactions

HEADACHE,FULLNESSINHEAD--
Ask"Doesyourheadfeeldifferent?Doesitfeellikethereisabandaroundyourhead?"D
onotratefordizzinesso rlightheadedness.Otherwise,rateseverity.

1 notpresent

2 verymild

3 mild

4 moderate

5 moderatelysevere
[Type here]

6 severe

7 verysevere

8 extremely severe

AGITATION--Observation.

0 normal activity
1somewhatmorethannormalactivity

4moderatelyfidgetyandrestless

7pacesbackandforthduringmostoftheinterview,orconstantlythrashesabout
ORIENTATIONANDCLOUDINGOFSENSORIUM--
Ask"Whatdayisthis?Whereareyou?WhoamI?"

0orientedandcandoserialadditions

1cannotdoserialadditionsorisuncertainaboutdate

2disorientedfordatebynomorethan2calendardays

3disorientedfordatebymorethan2calendardays

4disorientedforplace/orperson

TotalCIWA-ArScore

Rater'sIn

itials

MaximumPossibleScore 67

Themaximumscoreis67(seeinstrument).Patientsscoringlessthan 10
donotusuallyneedadditionalmedicationforwithdrawal.
[Type here]
[Type here]

APPENDIX-7
[Type here]

APPENDIX-8
HAMILTON DEPRESSION RATING SCALE(HDRS)

1 DEPRESSED MOOD (sadness, hopeless, helpless, worthless)

0 |__| Absent.
1 |__| These feeling states indicated only on questioning.
2 |__| These feeling states spontaneously reported verbally.
3 |__| Communicates feeling states non-verbally, i.e. through facial expression, posture, voice and
tendency to weep.
4 |__| Patient reports virtually only these feeling states in his/her spontaneous verbal and non-verbal
communication.

2 FEELINGS OF GUILT
0 |__| Absent.
1 |__| Self reproach, feels he/she has let people down.
2 |__| Ideas of guilt or rumination over past errors or sinful deeds.
3 |__| Present illness is a punishment. Delusions of guilt.
4 |__| Hears accusatory or denunciatory voices and/or experiences threatening visual hallucinations.

3 SUICIDE
0 |__| Absent.
1 |__| Feels life is not worth living.
2 |__| Wishes he/she were dead or any thoughts of possible death to self.
3 |__| Ideas or gestures of suicide.
4 |__| Attempts at suicide (any serious attempt rate 4).

4 INSOMNIA: EARLY IN THE NIGHT

0 |__| No difficulty falling asleep.
1 |__| Complains of occasional difficulty falling asleep, i.e. more than 1 ⁄2 hour.
2 |__| Complains of nightly difficulty falling asleep.

5 INSOMNIA: MIDDLE OF THE NIGHT

0 |__| No difficulty.
1 |__| Patient complains of being restless and disturbed during the night.
2 |__| Waking during the night – any getting out of bed rates 2 (except for purposes of voiding).

6 INSOMNIA: EARLY HOURS OF THE MORNING

0 |__| No difficulty.
1 |__| Waking in early hours of the morning but goes back to sleep.
2 |__| Unable to fall asleep again if he/she gets out of bed.

7 WORK AND ACTIVITIES

0 |__| No difficulty.
1 |__| Thoughts and feelings of incapacity, fatigue or weakness related to activities, work or hobbies.
2 |__| Loss of interest in activity, hobbies or work – either directly reported by the patient or indirect in
listlessness, indecision and vacillation (feels he/she has to push self to work or activities). 3 |__|
Decrease in actual time spent in activities or decrease in productivity. Rate 3 if the patient does not
spend at least three hours a day in activities (job or hobbies) excluding routine chores.
4 |__| Stopped working because of present illness. Rate 4 if patient engages in no activities except
routine chores, or if patient fails to perform routine chores unassisted.

8 RETARDATION (slowness of thought and speech, impaired ability to concentrate, decreased motor
activity)
0 |__| Normal speech and thought.
[Type here]

1 |__| Slight retardation during the interview.

2 |__| Obvious retardation during the interview.
3 |__| Interview difficult.
4 |__| Complete stupor.

9 AGITATION
0 |__| None.
1 |__| Fidgetiness.
2 |__| Playing with hands, hair, etc.
3 |__| Moving about, can’t sit still.
4 |__| Hand wringing, nail biting, hair-pulling, biting of lips.

10 ANXIETY PSYCHIC
0 |__| No difficulty.
1 |__| Subjective tension and irritability.
2 |__| Worrying about minor matters.
3 |__| Apprehensive attitude apparent in face or speech.
4 |__| Fears expressed without questioning.

11 ANXIETY SOMATIC (physiological concomitants of anxiety) such as: gastro-intestinal – dry mouth,
wind, indigestion, diarrhea, cramps, belching cardio-vascular – palpitations, headaches respiratory –
hyperventilation, sighing urinary frequency sweating
0 |__| Absent.
1 |__| Mild.
2 |__| Moderate.
3 |__| Severe.
4 |__| Incapacitating.

12 SOMATIC SYMPTOMS GASTRO-INTESTINAL

0 |__| None.
1 |__| Loss of appetite but eating without staff encouragement. Heavy feelings in abdomen.
2 |__| Difficulty eating without staff urging. Requests or requires laxatives or medication for bowels or
medication for gastro-intestinal symptoms.

13 GENERAL SOMATIC SYMPTOMS

0 |__| None.
1 |__| Heaviness in limbs, back or head. Backaches, headaches, muscle aches. Loss of energy and
fatigability.
2 |__| Any clear-cut symptom rates 2.

14 GENITAL SYMPTOMS (symptoms such as loss of libido, menstrual disturbances)

0 |__| Absent.
1 |__| Mild.
2 |__| Severe.

15 HYPOCHONDRIASIS
0 |__| Not present.
1 |__| Self-absorption (bodily).
2 |__| Preoccupation with health.
3 |__| Frequent complaints, requests for help, etc.
4 |__| Hypochondriacal delusions.

16 LOSS OF WEIGHT (RATE EITHER a OR b)

a) According to the patient :
0 |__| No weight loss.
[Type here]

1 |__| Probable weight loss associated with present illness.

2 |__| Definite (according to patient) weight loss.
b) According to weekly measurements:
0 |__| Less than 1 lb weight loss in week.
1 |__| Greater than 1 lb weight loss in week.
2 |__| Greater than 2 lb weight loss in week.

17 INSIGHT
0 |__| Acknowledges being depressed and ill.
1 |__| Acknowledges illness but attributes cause to bad food, climate, overwork, virus, need for rest,
etc.
2 |__| Denies being ill at all.

Total score: |__|__|

APPENDIX-9
HAMILTON ANXIETY RATING SCALE(HAM-A):

Each item: Absent-0, Mild-1, Mod-2, Sev-3, Very Severe-4

1. Anxious Mood (Worries, anticipation of the worst, fearful anticipation, irritability.)

2. Tension (Feelings of tension, fatigability, startle response, moved to tears easily,
trembling, feelings of restlessness, inability to relax.)
3. Fears (Of dark, of strangers, of being left alone, of animals, of traffic, of crowds.)
4. Insomnia (Difficulty in falling asleep, broken sleep, unsatisfying sleep and fatigue on
waking, dreams, nightmares, night terrors.)
5. Intellectual (Difficulty in concentration, poor memory.)
6. Depressed Mood (Loss of interest, lack of pleasure in hobbies, depression, early
waking, diurnal swing.)
7. Somatic (muscular) (Pains and aches, twitching, stiffness, myoclonic jerks, grinding
of teeth, unsteady voice, increased muscular tone.)
8. Somatic (sensory) (Tinnitus, blurring of vision, hot and cold flushes, feelings of
weakness, pricking sensation.)
9. Cardiovascular Symptoms (Tachycardia, palpitations, pain in chest, throbbing of
vessels, fainting feelings, missing beat.)
[Type here]

10. Respiratory Symptoms (Pressure or constriction in chest, choking feelings, sighing,

dyspnea.)
11. Gastrointestinal Symptoms (Difficulty in swallowing, wind abdominal pain, burning
sensations, abdominal fullness, nausea, vomiting, borborygmi, looseness of bowels,
loss of weight, constipation.)
12. Genitourinary Symptoms (Frequency of micturition, urgency of micturition,
amenorrhea, menorrhagia, development of rigidity, premature ejaculation, loss of
libido, impotence.)
13. Autonomic Symptoms (Dry mouth, flushing, pallor, tendency to sweat, giddiness,
tension headache, raising of hair.)
14. Behavior at Interview (Fidgeting, restlessness or pacing, tremor of hands, furrowed
brow, strained face, sighing or rapid respiration, facial pallor, swallowing, etc.)
APPENDIX-10
CHECKLIST FOR SIDE EFFECT OF tACS
0 1 2 3 4 5 6 7 8 9 10
1.Numbness at stimulation
site
2. Redness at stimulation site
3. Itching at stimulation site
4. Burning at stimulation site
5. Pain at stimulation site
6. Nausea
7. Fatigue
8. Nervousness
9. Insomnia
10. Headache
11. Difficulty in concentrating
12. Acute mood changes
13. Changes in visual
perception

The questionnaire contained categorical rating scales (from 0-none, 1- very mildly, 2-
mildly, 3- moderate, 4-severe, 5- very severe) for occurrence of 13 symptoms during or
after tACS.
[Type here]

APPENDIX-11
Clinical Global Impression-Improvement (CGI-I)
Rate total improvement whether or not, in your judgement, it is due to drug
treatment. Compared to his/her condition at admission to the project (screening)
how much he/she changed?
0 = Not assessed
1= Very much improved
2 = Much improved
3 = Minimally improved
4 = No change
5 = Minimally worse
6 = Much worse
7 = Very much worse

APPENDIX-12
ALCOHOL CRAVING QUESTIONNAIRE-SHORT FORM REVISED (ACQ-SF-
R)
1. If I had some alcohol, I would probably drink it.

STRONGLY DISAGREE___:___:___:___:___:___:___STRONGLY AGREE

2. I miss drinking.

STRONGLY DISAGREE___:___:___:___:___:___:___STRONGLY AGREE

3. I am not making any plans to drink.

STRONGLY DISAGREE___:___:___:___:___:___:___STRONGLY AGREE

4. I could not stop myself from drinking if I had some alcohol here.

STRONGLY DISAGREE___:___:___:___:___:___:___STRONGLY AGREE

5. I want to drink so bad I can almost taste it.

STRONGLY DISAGREE___:___:___:___:___:___:___STRONGLY AGREE

[Type here]

6. I would feel less irritable if I used alcohol now.

STRONGLY DISAGREE___:___:___:___:___:___:___STRONGLY AGREE

7. If I used alcohol, I would feel less tense.

STRONGLY DISAGREE___:___:___:___:___:___:___STRONGLY AGREE

8. Drinking would not be very satisfying.

STRONGLY DISAGREE___:___:___:___:___:___:___STRONGLY AGREE

9. I would feel less restless if I drank alcohol.

STRONGLY DISAGREE___:___:___:___:___:___:___STRONGLY AGREE

10. If I were using alcohol, I would feel less nervous.

STRONGLY DISAGREE___:___:___:___:___:___:___STRONGLY AGREE

11. It would be easy to pass up the chance to use alcohol.

STRONGLY DISAGREE___:___:___:___:___:___:___STRONGLY AGREE

12. Drinking would put me in a better mood.

STRONGLY DISAGREE___:___:___:___:___:___:___STRONGLY AGREE

TOTAL ACQ-NOW SCORE-