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The ethical obligations regarding Neurological research involving Magnetic Resonance

guided Focused Ultrasound


An Argumentative Research Paper
Earl Lofland
Delaware Technical & Community College

Authors Note:
This paper was prepared for Ethics in Health Care SOC203-412, taught by Tom Handlin

A very common movement disorder among patients with Parkinsons Disease and other
nervous diseases, including Multiple Sclerosis is a nerve disorder known as Tremors, two
of the most common tremors are Essential Tremor (ET), and Resting Tremors also known
as Parkinsonian tremor. (National Institute of Neurological Disorders and Stroke,
2012)
Though ET and RT fall under two different categories that impact a patient
differently, both are characterized by patients having uncontrollable shaking, or "tremors
which impact different parts of the body and different sides of the body. (WEB Med, LLC. )
Both types of tremors disorder are not life threatening except when the patient is unable
to care for themselves. However, both types of tremors are very significant disabilities
resulting in the poor quality of life (QOL) for people who endure life with either RT or
ET. Dating back to 1953, the first treatments were discovered to stop ET by accident
when a surgeon, Irving Cooper, severed, then ligated the anterior choroidal artery of a
patient while undergoing a pedunculotomy (Lozano Gildenberg and Tasker, (2009) Pg
11). During post-operative evaluations the patient was seen to no longer suffered from
rigidity or tremors. It was determined the tremors were stopped due to the lesion that was
made on the thalamus. Fifty other patients underwent this procedure making a lesion
on the thalamus with the same outcome as patient 1. Though there is no cure for
Parkinsonian Tremors or Essential Tremors, over the next several decades further
breakthroughs were made to either stop or reduce the tremors patients suffered.
(Neurosurgical Service, Massachusetts General Hospital, Harvard Medical School,
Boston, Massachusetts)

History of procedures
An initial breakthrough in the Neurosurgical intervention, came through utilizing
radio-frequency (RF) ablation that was invented by Bernard Cosman in 1939, who
partnered with Dr. William H. Sweet, MD, Chief of Neurosurgery at the Massachusetts
General Hospital (MGH), where they developed the RF generator that was used for
making lesions deep inside the brain to treat patients suffering from obsessive
compulsive, ET and other mental disorders. For ET lesions are made in the Thalamus
portion of the brain which eliminates abnormal nerve cells, by making an incision and
drilling into the skull, then inserting an electrode, which the tip is heated to around 56C,
and killing the cells. or deep brain stimulation (DBS) Where small battery-powered
device much like a pacemaker is implanted in the patients chest then the electrodes are
connected in the patients deep in the Ventral Intermediate (Vim) nucleus of the thalamus.
More recently a non-invasive procedure is undergoing clinical studies in the US at a
limited number of medical institutions, (U.S. National Institutes of Health)
incorporating Magnetic resonance and Ultrasound. Magnetic resonance guided focused
ultrasound (MRgFUS) was recently approved by the FDA (2016) and is showing
significant promises to manage this disorder, though there is no cure at this time for ET.
(Focused Ultrasound Foundation).
Both Deep Brain Stimulation (DBS) and Radio-frequency ablation (RF) require an
invasive operation that can result in attendant risks. Whereas MRgFUS is a non-invasive
alternative to the open approaches of neurosurgery, showing positive signs of reducing

many of the risks that were involved in Thalamotomy, and Pallidotomy, where the patient
has a small part of the globus pallidus ablated through open surgery, through (RF) and
DBS which requires a device similar to a pace maker to be installed in the patients chest
and the electrodes inserted in the brain.
This research paper will outline some of the ethical issues that surround MRgFUS
and the guidelines required by the clinical researchers in maintaining the homeostasis of
patients. What professional duties are required by the medical profession during the
clinical research focused on providing patients the ability to have improved quality of life
with less invasive surgery such as MRgFUS being conducted to eliminate or reduce
essential tremors. Due to the FDAs approval in 2016 the practice is relatively new in the
US, it is only being done at six Universities on a research level (U.S. National Institutes
of Health). In accordance (AMA Code of Medical Ethic (2016)). Both the patient and the
institution must first be approved by outside neurologists and an Ethics committee prior
to the procedure being performed at the facility.
There are also requirements for the patient in order be approved.
a team of medical professionals in neurology and radiology must
review the patients medical records to insure they are a qualified
candidate, the physician and the institute must also be approved for
performing the clinical trial by the National Institutes of Health, to
ensure that scientific, ethical and legal standards are upheld.
Institutional review boards, IRBs as well as individual investigators are
to ensure every participant (patient) is fully informed and have signed
a voluntary consent form with the understanding the patient can opt

out of continuing the trail study at any given time. Other ethical
requirements include the physician is to refuse any financial
compensation that awards the physician in excess of research efforts,
and should not accept payments solely for referring patients to
participate in the studies. The physician should not double bill a third
party payer (as we have also discussed in class). These and other
duties are in accordance to the AMA Code of medical ethics. The
integrity of the process is also to be preserved at all times. And the
highest level of confidentiality is to be protected by the physician and
the institution performing the research. These and many other ethic
codes are to be performed by the Institution prior to the clinical trials
are performed on the patients at that particular facility. Each facility
has an IRB that will conduct the investigations to insure both the
patient is being cared for with the utmost care being provided, and
accordingly the facility preserves all the integrity of the medical
profession, to prevent any conflicts of interest as well as breaches in
confidentiality and the utmost professional conduct is performed
throughout the entire duration of the research that includes proper
aftercare and post research evaluations

Sources

1. A.M Lozano, P.L. Gildenberg, R.R. Tasker Textbook of Stereotactic and Functional
Neurosurgery 2d ed. Pg 11, 2009 (ISBN 978-3-540-70779-0)
http://tinyurl.com/j6yv6n5

2. BioMed Central Journal of Therapeutic Ultrasound (2014) First


experience with MR-guided focused ultrasound in the treatment
of Parkinson's
diseasehttp://jtultrasound.biomedcentral.com/articles/10.1186/2
050-5736-2-11
3. Focused Ultrasound Foundation Essential Tremor Focused ultrasound treatment for
Essential Tremor has been approved by the Food and Drug Administration (FDA)

in July 2016. http://www.fusfoundation.org/diseases-and-conditions/braindisorders/essential-tremor


4. Focused Ultrasound Foundation Parkinsons Disease
http://www.fusfoundation.org/diseases-and-conditions/braindisorders/parkinsonian-tremor
5. G. Rees Cosgrove, MD, FRCS (C), Emad Eskandar, MD Neurosurgical Service,
Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts
THALAMOTOMY AND PALLIDOTOMY
http://neurosurgery.mgh.harvard.edu/functional/pallidt.htm

6. Hindawi Publishing Corporation Parkinsons Disease Volume 2015, Article ID 219149,


4 pages Research Article MRI Guided Focused Ultrasound Thalamotomy for
Moderate-to-Severe Tremor in Parkinsons Disease
http://dx.doi.org/10.1155/2015/219149
7. National Institute of Neurological Disorders and Stroke, 2012)

"Tremor Fact Sheet",

NINDS, Publication date July 2012. NIH Publication No. 12-4734

http://www.ninds.nih.gov/disorders/tremor/detail_tremor.htm
8. WebMD, LLC. (2016) The Brain and Essential Tremor
http://www.webmd.com/brain/essential-tremor-basics#1