BIC Protea syvson UCSB Brain Imaging Center 3T MRI Research Application (submit to Phil Beach, Dept. of Psychology: bie@psych.ucsb.edu) New Experiment [J] Renewal [J] Expedited Review Experiment Title: Predictiig Perceplue.d De cisions Fron, Hunan Braid Activity Using Machine L, atu Principal Investigator (Faculty memb« Campus Address: D806 Phone Number: _80S~ 842 - 22 55 Name/Address/Phone of other Researchers or Investigators: doc, RA, Non-UCSB PI)__MIGVEL EcksTETY TIN PRESTO. Human Subjects Approval Number: O8~SF__ Expiration Date: lif 2/27 Please attach copies ofthe following documents 1) Human Subject Protocol 2) Consent form 9) Description of experimental design (see next page) ordinator, Grad Stud, Post Resources requested: Number of sessions per subject:_2 Number of subjects: _U% Estimated duration of each imaging session:__2 hove s Scans per session (Check all that apply): % Coplanar anatomic scan “7 iMRI BOLD (standard 2D Single shot with iPAT GRAPPA) Number of runs:_1® & MPRAGE (standard TI weighted 8D high resolution anatomic scan) [3 FLASH Genes ‘T1 weighted sD high res anatomic scan, like a GE SPGR ) £1 DTI (number of tensors:. (minimum 30 recommended) (0Gradient Field Map [J] Other Total Scanning Hours Requested:(4@ | ‘Time of day (8am-4pm or after-hours): _Gath Who will do the imaging? TUM PRESTONBIC Prooeat sivor Funding: (Select one of the following five! (PF This study is funded by an extramural grant admi Funding Agency: CO. Is Ary - DOD Account to bill: W441NE - $4 - D- 6904 Tauthorize UCSB Bygggigg Conte bil recy We sbovewcount ng Sone as (J This study funded by another institution Name and Address of contact to bill studies: ea stered by UCSB [J] This study is for undergraduate instruction: Name of course: [J This study is supported by startup commitments by the Dean of my school [J Iam requesting UCSB BIC to subsidize this research as a pilot project If subsidized by the BIC, describe plans for obtaining future extramural funding: Stippulus Presentation and Re: LCD back-projection [J LCD front-projection [J Audio stimuli with Siemens headphones [J Audio stimuli with other headphones D¥f-Cedrus button box (up to 4 keys) terse button box (up to 10 keys) [3 Joystick [5 Special requests: Data path: {How do you want your data?) [J Burn a DVD (PC compatible only) (] Burn aCD Q2External hard drive [J sftp from MRI center tape archive to local computer Supplemental Description of Experiment Design’ In addition to providing the protocol submitted to CPHS for your human subject approval, please describe, in one page, your proposed experimental paradigm. Include details of the specific design (block, single event, multi-event, continuous), number of trials per event type, randomization procedure, assessment of orthogonality, triggering method and analysis methods For BIC use only: Scan Cost: ‘Number of Scan Hours approved Committee Review Date:_____ Renewal Date Approved for Human subjects? Other CommentsDO NOT WRITE IN THIS SPACE _08-51\7 sae, a 7 ae APPLICATION FOR HUMAN SUBJECTS USE 1. TF QUESTION IS NOT APPLICABLE TYPE “NIA E T= Professor, Prot Researcher Investigator_Miguel P. Rekstein *Title/Status_0__ 1 = Graduate Stier. UnderraduteStatere Faculty Advisor, *Title/Status Othe Phone_893-2255 _ E-maileckstein@psyeh.uesb.edu__ Funding Source_1CB/DoD Project Title Predicting Perceptual Decisions and Learning from Human Brain Activity Using Machine Learning Algorithms Administering New, Kenewal, Certification “Sue Hil, sanili@arlarmy mit; Project DepartmenvORU_ICB Subsidy, Modification N Contact Information (410) 278-6237 Begin Datel 1/4/08 ‘conaet @ extrarmval age) tn I TRAINING CERTIFICATION TRAINING: Oficial cerification is required ofall individuals condtng human subjects research or handling daa that eines identifiable private data of a human subject. The INVESTIGATOR or FACULTY ADVISOR, whoever is senior, is responsible for ‘ensuring that everyone working on this project completes the Human Subjects Training Module. Distribution of approval will not be done until all training is complete. Research cannot begin until all personnc! have completed training. FOR MORE INFORMATION ON TRAINING go to: http: tes lrda.uesb.edu READ THIS CERTIFICATION CAREFULLY. YOU ARE MAKING AN IMPORTANTCOMMITMENT. Tunderstand that I am responsible for the safe conduct of this projeet. Twill conduct this study in the manner described in this form. 1 will notify the Human Subjects Committee inumediatety to request approval 0 change any procedures or to report any problems that may put subjects at risk. ‘This includes any adverse reaction or risk associated with the study, including but not limited to: mental: distress regarding subject matter or procedures. cphnsical: injury, adverse reaction to biologicals, drugs, radioisotope labeled drugs, medical devices or equipment. confidentiality: access to data by unauthorized individuals, ¢ 10/22/08 Date Faculty Advisor! READ THIS CERTIFICATION CAREFULLY, YOU ARE MAKING AN IMPORTANT COMMITMENT. Tunderstand that Tam responsible for the safe conduct of this project. Thave read this protocol & believe thatthe student researcher is competent to conduct the activity described in this form & that the vlesiga meets the ethical standards of my field & the University. I will provide appropriate direction & supervision to ensure the safety of the research subjects. J understand that negligence of the actions of my student researchers will not absolve me of responsibility for them, Date Faculty Advisor Department Head: Tam aware this researel Jo(aele® Date a -partment Head being carried out under the auspices of my unit. [APPROVAL for HSC use only “The sigmature of the HSC Chair below indicates that the activity deseribed in the attached pages has been reviewed & approved. peel /(G/OR “conmn tin whe ven approvarDue!8/G 0B —espiraion dae W/FIA use cai EWAL MAS NOT BEEN APPR¢ RESEARCH MUST CHASE ON THE EXPIRATION DATE IF &INSTRUCTIONS FOR COMPLETION OF APPLICATION -On the attached pages, describe the activity, including all data & discussions that are specifically requested below. You may leave out any item that is not applicable to this project. However, any pertinent information that is omitted will delay review. Include any information that will assist the Committe in its review. -Cansult HSC staff at 893-3807 for information or assistance in completing the application, Deadlines for submission can be found at hitp:/research.uesb edu , or call 893-3807, -FULL BOARD REVIEW: Submit the original &10 copies ofthis application & all atachments to Office of Research, “EXPEDITED REVIEW: Submit the original & 2 copies (facully Pl) or 3 copies (student P!) to the Oifice of Research, “ALL REVIEWS: PROTOCOLS WILL NOT BE PROCESSED WITH INCOMPLETE INFORMATION 1. SUBJECTS: Deseibe your subject population. fe * Wiho ore your subjecis? + Four lay bo abanad aor elected? 1 matte mer age range? ati tit doent engage? {tthe suber population incute mines? Pisoners? Martalydsabled?istutanaized persons? Language handicapped? Others whose abit {vo voluntaty fom conser may be in quaston? yes, extn atonal forthe use FFAVSIOLOGIGAL RTEAVENTION os MAMPULATION(pysicl acy, ue of equipment n contact wy 5b a + isipossble ta subject might be pregiani? + Trews is involve, whats pryscal cordon o subjects? + Destrbe any sperial condion resent nthe subject popiaon. 1 Adeross special equvamnens fo eres nsuets oer ‘Subjects are normal healthy adults aged 18-45. Men and women are recruited in equivalent numbers. There are no minors, no prisoners, no mentally disabled or institutionalized persons. No language handicapped or other population unable to give informed consent ‘Subjects will be obtained from the UCSB Psychology student pool as well as campus advertisement. Students enrolled in Psychology 7 are provided with a handout describing their options of elther participating in ‘experiments or writing a course paper (attached). Then, they go to a web based program where they can select among different experiments. Once Army!IRB approval is finalized, the current protocol will be listed as well, Dotails of the signup for experiments can be found at the following web link http:tiwww. psych.uesb.edulundergraduateresources/psych'/psycht php Itis also included as a attachment After consent is obtained, the following criteria wil be used to determine eligibility Inclusion criteria: Normal corrected vision, overall good health. Exclusion criteria History or current neurologic disease (stroke, epilepsy, complicated migraine, major head trauma). History of major psychiatric illness requiring hospitalization or current use of psychiatric medication History of active recreational drug use. Pregnancy based on self report. Tatoos of the head and neck region History of prior surgery with metal clips, implants, devices or prosthetics. Cardiac or neural pacemaker ‘Metal piercing anywhere on the body. There is no known risk of MRI scanning to a fetus. However, as a precautionary measure, if a subject reports that they might be pregnant then the study will be cancelled. Pregnanoy testing is not performed. ‘Subjects will perform simple visual detection and classification tasks while in an MRI scanner. This will require looking at images presented and making responses with either a keyboard or joystick device. They will also be able to hear auditory instructions during the experiment. This does not require extraordinary physical stamina or conditioning, ‘human subjest are to be utlize. ‘What s tobe required ofthe suba0? ‘What data wil be recorded? owt wit information be soled? person ma interna, tc) Mi invesigaor or equipment ben physical comac wth subjects? + eserbe equipment & is nonmal& intended purpose + Assess safely of equpmen! use ns subject wl paripate? TION! (hysial avy, use of mesial enuipmen, ingestion af ay soliiqud cic) Se ee ie Daosind saad coca + Deserine any manipulations or interventions planned. + Where wil stuty be conducted?+ Ibo Nuids ae t be used, deserve method af removal or acquisition, vole, EH&S approval nfermation ‘Summary of modification to existing protocol: ‘We are adding a component where subjects undergo both EEG and fMRI scanning. EEG provides additional temporal information related to cognitive processing that is not available with conventional {MRI scanning. The additional tests carry no added risk. Finally, we have added a separate behavioral consent form for performing behavioral pilot experiments for ‘optimizing our protocols prior to fMRI or EEG testing, Purpose and Design of Project: This work is supported by the Army Research Laboratory and Dob. General Aims of the project The general aim of the research is to develop advanced computational methods to analyze human neural activity to: a) allow for reliable prediction of performance (accuracy) and decisions of individual humans in perceptual tasks; b) identify the time course of task-related neural activity, c) assess the correlated with task performance. If successful these techniques could lead to engineering techniques that allow for indirect neural based measurements of human task aptitude and propensity to perceptual errors. It would allow quantitative evaluation of different brain areas in terms of task- relevant information and their correlates with human decisions. ‘Specific Hypotheses tested: The specific hypotheses being tested are: Hypothesis 1: Can human performance (accuracy) in challenging perceptual tasks be predicted from brain activity? Test of hypothesis 1: We will test this hypothesis by measuring neural activity (EEG and fMRI) while human observers Participate in two different perceptual tasks. We wil use pattern classifiers to analyze the neural activity of individual brains and assess whether we can predict the observers’ behavioral performance in the perceptual tasks. Hypothesis 2: Are there specific temporal epochs of neural activity that can best predict human perceptual performance and errors? Test of hypothesis 2: We will take advantage of the high temporal resolution of EEG data to assess whether there are temporal epochs that best predict performance across our group of individuals. Of interest is to determine whether neural activity prior to the presentation of the visual stimulus can be used to predict perceptual errors. In addition, we will assess. the temporal persistence after the stimulus onset of the neural activity predicting perceptual performance. Hypothesis 3: Are there specific brain areas in which neural activity can best predict perceptual performance and errors? Test of hypothesis 3: The spatial resolution of fMRI and the independent delineation of brain areas using functional localizers (see methods) will allow evaluation of the ability to predict human performance from pattern classifiers which separately use groups of voxels from individual brain areas (e.g, face fusiform area, FFA; V1, V4, etc). Thus, we will be able to evaluate whether certain brain areas best predict human performance and errors Hypothesis 4: Are there specific time-epachs and brain areas that best predict the amount of learning of individuals? Test of hypothesis 4: To test this hypothesis, we will repeat the analysis using EEG and MRI but we will attempt to predict the change in perceptual performance across two independent sessions collected during different days There are 2 experiments under this protocol, with common procedures and risks. The only difference across experiments is that the images presented to the observers will be different (objects embedded in visual noise vs. simple forms ‘embedded in noise), For each experiment, up to 30 participants wil be recruited. In each experiment each participant will be asked to participate in up to 2 MRI brain imaging sessions (90 minutes for the first session and 60 minutes for the 2 session) to be completed over 2 week period. Participants will also be asked to participate in two electroencephalogram Peete areca eee erect eee Pee ee eee Ee oeSubjects will be paid on an hourly basis, Written informed consent will be obtained.” They may drop out at any time without penalty. Short behavioral testing sessions will be conducted at Dr. Eckstein’s Vision & Image Understanding Laboratory at UCSB> Participants will be trained shortly on the procedures of the perceptual tasks. During brain imaging they will perform similar tasks while activity in the brain is recorded. In addition to the functional scans, reflecting task dependent brain activity, MRI scans of brain structure/anatomy will be obtained. In addition to the images corresponding to the perceptual task all subjects will be presented with other sets of images known as functional localizers to segment diferent functional visual areas in their brains, During EEG session, a 64 electrodes, mounted in an elastic cap, will be placed on the Subjects head. Electrical conductvity is achieved using a small amount of non-toxic electrically-conductive gel that is placed between the electrode and the scalp to ensure that a clean recording is obtained. This procedure takes about 20- 30 minutes. Subjects then sit in a comfortable chair and perform behavioral tasks. Accuracy and speed of response are recorded. The experimental session can take up to 90 minutes, The brain imaging will be performed at the UCSB Brain Imaging Center in the basement of the Psychology East Building Brain Imaging will be performed on a Siemens Trio 3T whole body MRI scanner. This is an FDA approved medical imaging device. The scanner at UCSB is used for research imaging and not clinical diagnosis. However, all scanning procedures in this protocol will be performed within FDA approved limits for clinical MRI. That is, the power output and Gradient strengths will be within normal clinical parameters to minimize risk of neuromuscular stimulation from the scanner and to minimize energy (heat) dissipation to the subject. All imaging protocols will be supervised by the Director of the Brain Imaging Center (Grafton), a certified MRI technologist, or a faculty member or student trained in the safe use of the device. EEG will be obtained in the Dr. Giesbrecht’s EEG lab in the Psychology building at UCSB. Data to be recorded for each subject: Demographics Behavioral test results (reaction time, accuracy) High density EEG scan of the brain. Echo-planar brain images for functional assessment Diffusion Tensor brain images for white matter assessment MPRAGE- brain images for gray matter assessment No substances are ingested 3. RISK: Identify & discuss all known potential risks & expected discomforts, including: + Psychological ~ Invasion of privacy. |» Incomplete consent» Physical injury. + Exposure to chile |» Embarrassment damage. (deception) ciminal action. or discomfort + Exposure to * Loss of jab, + deni of subjects recorded ANYWHERE- + Exposure to sk from UCSB's mandatory vwolence, employability Including trough increct cases ar tnks. child abuse reporting requirement. ‘other nancial risk + Coercion: use of your own students, staf,» Assess iksihood & + Other applicable risks not isted here. friends, ec. nancial incentives; exra cect. _ seriousness of risks oi et red & hy they wll not be used PHYSIOLOGICAL INTERVENTION or MANIPULATION: (nysiea acy, ue of mesial equoment, ington of any soldgid te) escribe adilanal sk io subjects due to pysicalconcion be ari oa pssibie fetus fan unknoan pregnancy (pregnancy, less, sedentary Mesivc, te.) [a i) invaved There are no risks associated with the visual, auditory memory and motor behavioral experiments of this project. There are no risks associated with EEG procedure. Standard EEG recording equipment protects the volunteer from any hazard Of electrical shock using resistors and isolated grounding procedures. Cap sterilization procedures conform to published guidelines for protection of volunteers from transfer of viral or bacterial agents via electrodes. Briefly, the electrode caps (with electrodes in place) and any loose-lead electrodes are washed using detergent and warm water, then rinsed thoroughly. They are then placed in a solution of Metricide or a water-isopropyl alcohol solution for 15 minutes and then rinsed with filtered water, The risks of participation in the MRI scanning procedure are minimal: (1) There is a potential risk from exposure to magnetic fields at 3.0 Tesla, The risk is associated with metal on or in the subject. Within the MRI scanner metal can move, be dislodged from the body, or become hot. This risk is eliminated by detailed prescreening of subjects to assure Paar eee aaa age eeemetal detecting wand before entering the magnet room. Third, they wear clothes without metal. They are provided with hospital “scrubs” to wear if needed. Fourth, they are monitored throughout the procedure by trained personnel, Subjects with un-removable piercings or head and neck tattoos are excluded from study. Subjects with metal prosthetics, such as artificial knees, are considered on a case by case basis under the supervision of the Imaging Center Director (Grafton) Orthodontal metal including fillings and bridges pose no risk and are allowable in the MRI scanner with the proviso that the imaging data can be reduced in accuracy. (2) There is no known risk of magnetic fields at 3.0 T to a fetus of a pregnant women. As reviewed in “Magnetic Resonance, Bioeffects, Safety and Patient Management, by FG Shellock and E Kanal, Lippincott Willams ad Wikins, 1996" there is no human data demonstrating any adverse effect of low magnetic fields to a fetus, Furthermore, there is no animal model that demonstrates a reproducible adverse effect of a low magnetic field to a fetus. Nevertheless, as an added precaution, if subject is pregnant, based on self report, they will be precluded from participating, (3) Functional MRI scanning prodiices a loud (90 dB) approximately 1300 Hz tone that can cause hearing damage, thus ‘appropriate hearing protection will always be provided and required by all persons in the magnel room including the subject. Standard industrial ear plugs have sufficient sound atlenuation to eliminate this risk (4) MR gantry is a small opening (approximately 3 feet in diameter) within which the subjects must remein during the ‘experiment. In addition, the functional scanning coil closely encloses the subject's head. These features increase the likelihood of claustophobia. This occurs in approximately 10-15% of the normal healtny adult population. There is no permanent risk from this sensation. Subjects are informed to let the investigator know if they are anxious or uncomfortable, in which case the study is discontinued, 4, SAFEGUARDS: Describe procedures for protecting against or minimizing potential risks. Assess kel effecvenass of procedures used to reduc risk ‘© How vill data be stored in he field & at homebase™> ‘+ How ill nvasion of privacy be aveided or minimized? + Who wil nave access to dentable data & how wil it be hmted? Wen wil identifiers be stipped from data or data be destroyed? «Wil subjects be alowed to edt transcripts or vdeo? Procedures used for masking idenies in publity avalable materials or methods for obtaining subject's release for use of tir ident. + Describe perinent exo investigators. +Other ne jeguards nol sted hare, >¢ MANIPULATION: (physical aciviy, Use of medical aquipment, ingestion of any soligud, alc) Describe procedures used to identi at risk subjects, escribe method & frequ ng subjects + Indicate whether atvisk subjects wil be enrolled with additonal + Describe adcitional safeguards used to protect at risk subjects safeguards or not enoled inthe project. + Doserive vaininglicenece of PI who will be performing procedurc(a) + What are the ceria fr terminating a subjed's patcipetin? ‘+ How wil substances to be ingested, inhaled, or apolied topically be + Wil physician & appropriate medical suppis be avaiable? obtained? Stored? Handled? As noted above, a detailed metal screening procedure is used to minimize risk associated with metal on or in the body. A copy af the metal screen is included as an appendix. Ear plugs or ear protectors (headphones) are used for hearing protection Warnings, including the specific dangers of high magnetic fields are posted at the main entrance. All people entering the exam room where the magnet is located will be screened by questionnaire for magnetic material before entering during a study. This includes subjects, as well as attending experimenters, and staff. All behavioral data is codified without subject identifiers. All brain imaging data is codified with alphanumeric descriotors that do not use subject name. Behavioral data is stored on password protected computers by each of the investigators Imaging data is archived in a password protected central archive (only the investigator has access to this data partion) as well as on the investigators password protected laboratory computer. (Only the investigator or their laboratory assistant/grad student fellow will have access to any dala There are no transcripts or videos. Data will be kept in a secured facility for 7 yearsSafe entry of the MRI scanner room depends on careful screening of the subject for metal and preventing any foreign metal (oxygen tanks, pens, computers) from entering the magnet room. To enter the magnet room, @ person must be either a subject who has been screened or an investigator who has been screened AND has completed an MRI safety course. This course requires viewing of a safety video and completion of a short written or oral test administered by the staff MRI technologist or the center director. Safe operation of the MRI scanner requires detailed training in the operations of the magnet, Most experiments will be run with a certified MRI technologist with expertise in the scanner system present. This technologist will also train graduate students, post doctoral fellows and faculty to operate the scanner on their own. These trainees must complete a detailed tutorial and test of competency. Once they are certified to operate the scanner, they are required to do this with a second person in attendance to provide assistance The Center director has greater than 10 years experience with MRI centers, and 20 years with nuclear medicine methods, A conior level MRI technologist is currenily being recruited to oversee day to day operations. CONSENT: Describe procedures for obtaining informed consent. How, “where & under what condiions wil | Consent fos must be signed by fe sbjec andor by Whe pare or egal guaran Consent be obtained? Include who wil obtain | forms must be stored securely in Deparbmental Offces. Consult HSC staff al 893-2807 regarding consent. | retention pero. CHILDREN'S ASGENT: Vf cir over Sven years old are voted in th rere requ explain the reasons fr his rea WAIVER OF DOCUMENTATION: If signed consent forns wil nol be usec, sala wal information wil be Given 9 subjecls & explain whlch of the Following criteria applies to your project 1) The principal risks are those associated with a breach of confidentiality concerning the subject's participation inthe research AND the consent document isthe onl record linking ine subject with the research 2) The research presents no more than minimal risk and involves procedures that do net require written cansent when they are performad outside ofa research soting, “DECEPTION: Ifthe consent procedure om ‘Wy the research could not practicably be cariad out without he waiver or alteration: ‘Why tha project wil present no mere than minimal risk ta the subjects + Vihy the waiver or alteration wil not adversely effect the rights and welfare of the subjects; «ina alg sotto be usd (Deng sou ole pla too a ch meth compte’ he sty, eer nerig at act) COERCION: The subject must be given the opportunity to conse force, raud, icky, duress, coercion, or undue Iuence on te subjects decison, To neue Bi, any payment or Gass cred must be appropiate tothe asks mvoWed an the aubjest population. Any project whore olaca oredt i involved must bo open tall members ofthe claeg AND thore must be non research option to effort. Payment LANGUAGE: Make sure your consent form is writer in language het clear, concise & understandable lo your subject population. TWs includes bath reading level and language (English, Spanish, French etc) Fie specic jargon should be avoided and all concepts should be explained in lay terms. TRANSLATIONS: Consent forms should be translated into the target language and Yransated back into English by two different people fo insure the appropriate concepts are being conveyed. This procedure shouldbe documented here, a need. Wa walver of the Informed consent will be obtained by one of the investigators or a designee who has been trained and certified in human subject procedures. The nature of the experiment and procedures will be explained to the subject in plain language. All of their questions will be answered. The requirement that subjects be screened for metal will be explained. If they are ready, subjects will then read and sign the consent form. Then they will complete the metal screening form. All signed consent forms will be kept in a locked cabinet. There are no children, and no waivers, There is no deception and no coercion, Because the subjects come primariy from a student pool, we will explain to all potential subjects at the start of the consent procedure that they are not obligated to participate in this experiment as part of their course requirements, ELEMENTS OF INFORMED CONSENT: Minimum information to be given to research participants to obtain Informed Consent7 Investigators narve, phone number, & times whan he/she can be 75: An afar ariswer any questions concerning We Suay, reached. 11. An instrcton that paicipation s entirely voluntary & consent to 2. A description ofthe nature & purpose ofthe study participate may be withdrawn at any time without prejudice 3. The expected duration of the subjects partcisaion. 12, An instrucbon that either the Investigator or the subjact may terminate 4, statement descriting the extent, if ary, to which configentialty of the subject’ participation at anytime, & Ue subjects belng pale, the records idertiying tne subject vill be maintained, Percentage payment ta be expected if particpaton Is terminated. ‘5. An explanation of the procedures to be followed, any drug or device to | For any study which may eesull in physical injury, addition of the following be ublzed,& any foreign substance tobe acnistored. | statement 6. Idontiaton of procedures, drugs, or devices which are exparmental 7. Seseripton of any atondant eieeonvors& rskereesaraby tobe, || The University of California does not provide compensation xp for injury to human subjects of research except that the 8. Where applicabo, the ascosure of any appropri ateave Univers will provide for any madical care required to teat procedures. drugs or devices that might be advantageous to be any injury resulting from participation as a human subject in ‘subject, & their relative risks & benefits, a University-approved activity. If you have any questions 8. An Seana of ary bene eset eased be concemming this or any other ater relating o your ee reer e tenet participation in this activity, please call 893-3807. List the numbers above that + do not apply to your research: sone + you wish not to disclose & have justified the omission or aeration above (Deception: ‘BENEFITS: Describe benefits to be gained 1 To the subjects, to class of subjecs, to society o advancement of knowledge ‘There are no direct health benefits to the subject. There are benefits to society based on the premise that this information is fundamental for understanding normal brain structure and funct 7_RISK-BENERT=RATIO™ Aaiviosivevng human sbjcs an only bo approved expected bono outegha he Hak + Sat youreasons for boloing tat ho bens four roposed acy oulvag he posse The benefits from insights gained by understanding brain mechanisms that underlie normal cognition are far greater than the minimal risk of the procedures. ‘8. ATTACHMENTS: Check all that apply. Collate & staple these materials, in the order listed, to each copy of this applic Instruments (surveys, questionnaires, scales, etc) Script of oral directions to subjects ‘Consent frm (to be signad Consent information Sheet (Documentation walvedino signature collected) ‘Mosified Information Sheet (Deception/eloments of informed Consent omitted or alteredino signature collected) Debriefing form providing informaton to subjects abaut omited or altered consent elements (required for deception cesearch) Recruitment material (hand outs, fyers, advertisements, script of oral invitaion to participate, et.) Other st below “Metal screening form 2VENTIONS OR MANIPULATIONS — Neal Fistor screening instruments feces Documentation of acceptable standard for use of medical equipment & for substances tobe ingested or inhaled. ‘3, REPORT OF PROGRESS - For Renewal applications only TTihis fs an ongoing project, of you have previously conducted @ Slr great, Gesorba @xpariencas withthe use of fhe harran subjects in he projet. se describe any experiences that may assist the HSC in reviewing similar projec, Include: Torben Eps Tad “conpicatons nt oat ubjecis the protocsl since the last apprPage 1 of3 UC Santa Barbara Consent to Participate in Research TITLE OF STUDY: PREDICTING PERCEPTUAL DECISIONS AND LEARNING FROM HUMAN BRAIN ACTIVITY USING MACHINE LEARNING ALGORITHMS Lead Investigator: Miguel P. Eckstein (eckstein@psych.uesb.edu) Co-Investigator: Barry Giesbrecht PhD (giesbrecht@psych.uesb.edu) Department of Psychology UCSB Santa Barbara, California 93106 Phone (805) 893-2255 PURPOSE: You are being asked to participate in a research study. Your participation is voluntary. Please feel ree to ask questions at any time if there is anything you do not understand, The goal of these experiments is to investigate how brain function is localized in the brain and how it changes with practice, experience or strategy. You are being asked to participate because you are a normal healthy adult. Your participation allows us to determine basic principles of brain organization. The data obtained through your participation will be included with that from ‘other subjects as part of a scientific study to appear in the peer-reviewed literature. Ultimately, these results may be useful for understanding how patients recover from brain injury or disease. The Department of Defense is funding the research study. PROCEDURES: If you decide to participate we will ask you to do three things. The first is behavioral tests with a computer outside of the MRI scanner. During the behavioral testing session, you may be asked to classify an image seen on a computer screen, to search for a target in the image. The second set of tests consists of MRI scans of the brain. The third set of tests is electro encephalograms (EEG) MRI: This is a special three-dimensional picture ofthe brain using magnetic waves. You will lie inside a narrow tube and hold stil for up to one and a half hours. Throughout the study you will be visible to the experimenter by means of a window and you will be in direct verbal communication with MRI personnel at all times. You will view pictures or words on a computer screen specially designed to work with the MRI machine and you will be asked to make responses in the form of button presses or hand movements. During the experiment itis very important for Participants to remain as stil a possible since the brain Imaging technique is very sensitive lo movernent, Yuu will be given specific instructions at the start of each task on what type of movements to make. Please ask the experimenter any questions that may arise while you are doing the task(s). At separate times we will do further testing with a regular desktop computer outside of the scanner. Please Note: MRI is commonly used in medicine for the purpose of diagnosing abnormalities ofthe brain ‘The procedures that are to be used in this study are different from MRI scanning used in medicine. There is no intention to make any medical diagnosis with the MRI as used in this research setting. any incidental abnormalities are discovered from the limited scanning information available, you will be contacted by the investigator. Each scanning session will last no more than 90 minutes. Several types of brain image data may be collected as part ofthis investigation. This will include one or more ofthe following ‘A scout image for use in aligning the scanner’ field of view (~15 seconds) ‘A quick anatomical image of your brain structure for use in data processing (~2 minutes) One or more series of brain images collected over time that track brain function during the performance of @ cognitive or behavioral task (each typically 5 to 10 minutes in length) ‘A high-quality image of your brain structure for use in the display of results (~10 minutes) A diffusion image might be also acquired for assessing white matter organization in the brain and often Used in data analysis and modeling (~10 minutes) y voy y Data on your contact information will be collected as part of the screening process in order to contact you for participation in future session or studies, Data concerning your age, sex, handedness and how you performed on the particular task will also be collected as part of the study.EEG acqui Page 2 of 3 Depending on the specific experiment, you will be asked to participate in up to 8 MRI brain imaging sessions (90 minutes each) and five behavioral testing sessions (60 minutes each) to be completed over a ane year period. You may drop out at any time without penalty. ALTERNATIVES: There are no alternative techniques that can provide this type of information on human structure and function. if you are a student subject, there are alternative experiments available to you. EEG: During EEG session, a 64 electrodes, mounted in an elastic cap, will be placed on your head, Electrical ‘conductivity is achieved using a small amount of non-toxic electrically-conductive gel that is placed between the electrode and your scalp to ensure that a clean recording is obtained. This procedure takes about 20-30 minutes. You will sit in a comfortable chair and perform behavioral tasks. Accuracy and speed of response are recorded. Throughout the study you will be in direct verbal communication with EEG personnel at all times. The experimental session can take up to 120 minutes. ALTERNATIVES: There are no alternative techniques that can provide this type of information on human brain function at high temporal resolution. if you are 2 student subject, there are alternative experiments available to you. RISKS MRI scans: The risks of participation in the MRI scanning procedure are minimal. There is no measurable risk to being exposed to magnetic fields at the strength used in this experiment. There is no long term safety data available for exposure to multiple MRI scans, Special considerations are made for the following: 1. Metal: The MRI machine produces a constant, strong magnetic field (3 Tesla), so if you have metal implants, and clips within your body they may be influenced by the magnetic field and shift in position. Thus, if you have such Implants you must inform us and withdraw from the study. Metal earrings and necklaces also must be removed prior to the study. If you have shrapnel, surgical implants, or other pieces of metal in your body that cannot be removed, you may not be able to participate in studies involving the MRI scanner. In many cases, people having dental appliances in their mouths can participate but should notify the investigator to be certain. Clothing with metal cannot be worn in the scanner. We can provide suitable clothes for the study as needed 2. Women of child bearing potential: The risks of an MRI scan to the unborn fetus are unknown. We stronaly Fecommend preqnant women do not take part in this research study. By signing this form you are indicating to the best of your knowledge that you are not pregnant. If you aré uncertain then the study can be rescheduled to allater date. 3. Hearing: Functional MRI scanning produces a loud (92 dB) high frequency tone that can cause hearing ‘damage if appropriate hearing protection is not used. Adequate hearing protection in the form of foam ear-plugs will be provided and required 4. Claustrophobia: The functional scanning col fits closely around your head, so if you feel anxious in confined spaces, you may not want to participate. If you decide to participate, and then at a later time decide to discontinue, just let us know and we will stop the experiment. ition: There are no risks associated with the visual, auditory memory and motor behavioral experiments Of this project. There are no risks associated with EEG procedure. Standard EEG recording equipment protects the volunteer from any hazard of electrical shock using resistors and isolated grounding procedures. Cap sterilization procedures conform to published guidelines for protection of volunteers from transfer of viral or bacterial agents via electrodes. Briefly, the electrode caps (with electrodes in place) and any loose-lead electrodes are washed using detergent and warm water, then rinsed thoroughly. They are then placed in a solution of Metricide or a water-isopropyi alcohol solution for 15 minutes and then rinsed with filtered water. BENEFITS: There are no direct benefits to you in participating in an MRI study of brain function or an EEG study, These data are collected purely for the purposes of research and do not have a clinical or diagnostic value.Page 30f3 CONFIDENTIALITY: All information you provide will be kept confidential except as required by law. Your name will not be used in any publication that may result from this study. Your name or other personal information will not be used to identify the scans or blood sample. The Office of the Committee for the Protection of Human Subjects at UCSB may request access to this form to ensure procedures designed to protect research participants are being properly followed. Representatives of the U.S. Army Medical Research and Materiel Command are eligible to review research records as a part of their responsibil to protect human subjects in research. The manufacturer of the MRI scanner (Siemens) may request the use of images acquired in this study, although they will not have access to the names of any subjects. Your data may also be shared with other researchers around the world or with a publicly available data archive. In such cases, all identifiers will be removed from the data that would indicate any connection to you (e.g. the removal of your name, address, SSN, etc.) COSTSIPAYMENTS: There are no costs to you for your participation in this study. If you are not a student receiving academic credits for your participation, you will be paid for your participation using the following guidelines: At the rate of ‘$20_hour EMERGENCY CARE AND TREATMENT FOR INJURY: [f you are injured as a direct result of research. procedures, you will receive reasonably necessary medical treatment at no cost. The University of California does not provide any other form of compensation for injury. RIGHT TO REFUSE OR WITHDRAW You may refuse to participate at any time. This study and your participation has no effect on any medical care you receive. You may change your mind about being in the study and quit after the study has started. If you area student your decision whether or not to participate will not have any affect on your academic status. The investigator may withdraw subjects from the study at his/her discretion Expiration Date on the Viability of the Data Collected: Data gathered from this study will be maintained by the investigator indefinitely or as required by federal or state regulation. YOUR RIGHT TO WITHDRAW FROM THE STUDY: You may withdraw from the study at any time and for any reason, Your decision whether or not to participate in this study, or a decision to withdraw will not involve any penalty or loss of benefits to which you are entitled, PRINCIPAL INVESTIGATOR’S DISCLOSURE OF PERSONAL AND FINANCIAL INTERESTS IN THE RESEARCH AND STUDY SPONSOR: The study investigators have no financial interest in this research and wi rnot benefit monetarily from this study. QUESTIONS: If you have any questions about this research project or if you think you may have been injured as a result of your participation, please contact Miguel P. Eckstein at 805-893-3045, eckstein@osych ucsb.edu, Department of Psychology, Room 3808, UCSB, Santa Barbara, CA 93106. If you have any questions regarding your rights and participation as a research subject, please contact the Human ‘Subjects Committee at (805) 893-3807 or hsc@research,ucsb.edu. Or write to the University of California, Human Subjects Committee, Office of Research, Santa Barbara, CA 93106-2050 CONSENT PARTICIPATION IN RESEARCH IS VOLUNTARY. YOUR SIGNATURE BELOW WILL INDICATE THAT YOU HAVE DECIDED TO PARTICIPATE AS A RESEARCH SUBJECT IN THE STUDY DESCRIBED ABOVE, YOU WILL BE GIVEN A SIGNED AND DATED COPY OF THIS FORM TO KEEP. 5 aaa Time Witness Date TimePage 4 of 3 We may want to contact you in the future to participate in additional, similar studies. Please indicate below if you would like to be contacted at a later date by initiaing next to your choice below. | would like to be contacted for future studies related to this research. | authorize you fo contact ‘me in the future: Ido not want to be contacted for future studies related to this research. Please do not contact ime in the future.Predicting Perceptual Decisions and Learning from Human Brain Activity Using Machine Learning Algorithms Proposed Experimental Design: Functional Localization: ‘We will use functional localization scans based upon standard techniques to identify visual areas in individual observers. Specifically, we will use retinotopic localizers utilizing continuous presentation of periodic stimuli consisting of rotating wedges and expanding rings to identify retinotopically organized visual areas (V1 — V4 [ventral] — V7 [dorsal]). The motion sensitive area hMT+/V5 will be identified using a block design contrasting a radial array of dots depicting expanding and contracting motion with a static array of dots. The fusiform face area (FFA) will be identified using a block design contrasting images of faces with scrambled faces. The object sensitive lateral occipital complex (LOC) will be identified using a block design contrasting images of objects with scrambled objects. Each of these localization scans will last 5-10 minutes. In block designs, stimulation periods will be 16-20 seconds interspersed with 16-20 seconds of baseline fixation. Event-related experimental design: ‘We will use a fast multi-event-related design with 20-50 trials of each event type per run for a total of 200-500 trials per session. The event-related design sequence will be based on either a m-sequence or optimized using a genetic-algorithm based approach. Both of these approaches will produce appropriate levels of randomization and orthogonality between event types. Inter-trial intervals will be jittered to optimize detection power using a genetic-algorithm based approach. Prior to running the experiments computer simulations using these designs will be conducted to ensure the statistical properties of the designs are well understood. Stimuli will be presented using custom software written in MATLAB using Psychtoolbox 3. Stimulus presentation will be triggered by output of the scanner at the beginning of each TR. Analysis methods: The software package Freesurfer will be used to generate inflated and flattened meshes representing the grey-white matter border from individual subject’s anatomical scans. Preprocessing of functional data (coregistration, motion-correction, linear trend removal) will be carried out with the software package SPM5. General linear model (GLM) analysis of the functional data will also use SPMS. Further, data from the the functional localization scans will be used to define regions of interest (ROD) on individual subject's anatomical meshes. Functional data from within these ROIs for experimental seans will be used to perform ROI-based analyses. This will include comparisons of % fMRI signal change between conditions as well as multi-voxel pattern analysis (MVPA) classification analysis and additional multivariate techniques to assess the information content of individual ROIs. This analysis will use custom software written in MATLAB.