Transcranial Magnetic Stimulation in Obsessive Compulsive Disorder: mechanisms and biomarkers.

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    Recruiting
Updated on 23 November 2020

Summary

Transcranial Magnetic Stimulation in Obsessive Compulsive Disorder: mechanisms and biomarkers.

Description

We are doing a treatment study to examine the use of transcranial magnetic stimulation (TMS) in treating people with OCD and to investigate what areas of the brain are involved during emotional learning. TMS is a noninvasive method in which a magnetic “coil” is placed near an individual’s head and delivers small magnetic pulses into the brain, which produce small electrical currents in the brain, stimulating brain cells that may relieve OCD symptoms. TMS has been FDA approved since 2008 and Health Canada approved since 2002 as a treatment for depression. Our hope is to demonstrate that TMS is a successful treatment option for individuals struggling with OCD symptoms, and to identify the specific areas of the brain that are targeted through TMS.

If you have OCD and are enrolled in this study, you may be randomized (like the flip of a coin) to one of two groups: you will either participate in 6 weeks of daily, active TMS, or partake in 6 weeks of placebo (sham) TMS sessions. During phase I, your participation in this study will last about 8 weeks and you will be asked to make about 36 visits to our clinics at the MGH main campus and the MGH Charlestown Navy Yard campus during the study.

The appointments include:

  • A baseline clinical appointment (~3 hours) taking place in the Richard Simches building at MGH main campus near the red line T stop
  • A baseline 2-day series of MRIs, typically on Mondays and Tuesdays, but somewhat flexible, occurring at the Charleston Navy Yard campus of MGH
  • Daily TMS appointments, Monday through Friday, each lasting about 45 minutes, occurring at the CNY campus
  • Bi-weekly clinical assessments occurring over the phone (sometimes) and in-person at the main MGH campus
  • Bi-weekly neurophysiologic (measuring changes in how your brain functions) occurring adjacent to TMS appointments at the CNY campus
  • 3 more MRI appointments, at the end of week one of treatment (one day) and at the end of treatment (two days, back to back), occurring at CNY
  • One in-person 3-month follow up assessment, occurring at the MGH main campus

If your symptoms do not improve after phase 1, you will be invited to participate in phase 2. During phase 2, you would receive 30 active TMS sessions over 6 weeks. There would be several additional MRI scans and clinical assessments, similar to phase 1.

Part of the MRI scanning sessions will include participating in a task that uses mild, half-second electric shocks to your fingers. The electric current will be generated from a 9V battery (e.g., battery in a smoke alarm), and is much less annoying than a static shock. In order to set the level of the current to be used during the study, we will begin at a level below what you will be able to feel, and then increase in gradual steps with your permission. You will be asked to stop the increase at a level of the current that you find highly annoying but not painful. The level of current that you select during this trial procedure, and no higher level, will be used during the study so that you will not receive any painful electric shocks. The purpose of the electric shock is to create a situation in which emotional learning may occur. You will receive no more than twelve of these electric shocks.

For more information, please contact Dylan Abrams at 617-643-4387 or dabrams3@mgh.harvard.edu.

Details
Condition Obsessive-Compulsive Disorder, Anxiety Disorders
Clinical Study IdentifierTX145181
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

18-65 years of age
Proficient in English
A diagnosis of primary OCD (as determined by SCID)
Yale-Brown Obsessive Compulsive Scale total score ≥ 16
Normal (or corrected) vision
Stable OCD medication regimen or OCD medication free for ≥ 12 weeks prior to study; benzodiazepine free ≥ 2 weeks
Able to give informed consent

Exclusion Criteria

Current or history of neurologic or psychiatric disease (e.g., mental retardation, dementia, brain damage, or other cognitive impairment) that would interfere with ability to engage in TMS
Psychopathology not appropriate for the treatment (e.g., manic episode or psychosis)
Substance abuse or dependence that is current or within the last six months or use of an illicit drug that is not prescribed, as indicated by a urine drug screen and/or clinical inference
Use of benzodiazepines or anticonvulsants within 2 weeks prior to study (to be ruled out by a urine drug screen)
Use of Tricyclic Antidepressants (e.g. Clomipramine)
Use of psychotropic medication is allowed (except for the limitations specified on use of OCD regimens, benzodiazepines, anticonvulsants, and tricyclic antidepressants)
Documented resistance to 4 or more valid pharmacological trials of 2 or more different medication classes (e.g. SSRIs and TCAs)
Previous exposure to TMS
Major/chronic medical conditions
History of head injury resulting in prolonged loss of consciousness and/or neurological sequelae
Prior neurosurgical procedure
Metal in the body that is ferromagnetic, metal injury to the eyes
History of seizures
Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculo-peritoneal shunt
Pregnancy; breastfeeding or nursing; for women of childbearing a pregnancy test (to be ruled out by urine β-HCG) will be conducted prior to study
Currently in Cognitive Behavioral Therapy (CBT)
Diagnosis of primary sleep disorder such as primary insomnia, narcolepsy, sleep apnea, shift work sleep disorder and others. Sleep disorders such as insomnia or hypersomnia that are secondary to depression or OCD are permitted
Current clinically significant suicidality
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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