Transcranial Magnetic Stimulation (TMS) in Obsessive Compulsive Disorder (OCD): Mechanisms and Biomarkers
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to test the efficacy of 1-Hz repetitive transcranial magnetic
      stimulation (TMS) over the pre-supplementary motor area as a treatment for obsessive
      compulsive disorder. Additionally, this study aims to identify the mechanisms of action of
      TMS and potential biomarkers and predictors of treatment response.
    

Detailed description: 
      This treatment study examines the use of transcranial magnetic stimulation (TMS) in treating
      people with OCD and investigates 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.

      Patients will be randomized (like the flip of a coin) to one of two groups: 6 weeks of daily
      active TMS, or 6 weeks of daily placebo (sham) TMS sessions. During phase I, participation in
      this study will last about 8 weeks and patients will be asked to make about 36 visits to our
      clinics at the MGH main campus and the MGH Charlestown Navy Yard campus. Patients will also
      participate in MRI scanning sessions and clinical assessments.

      If patients' symptoms do not improve after phase I, they will be invited to participate in
      phase II. During phase II, patients receive 30 active TMS sessions over 6 weeks, as well as
      MRI scans and clinical assessments.

      Part of the MRI scanning sessions will include participating in a task that uses mild,
      half-second electric shocks to 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 patients will be able to feel, and then increase in gradual steps with permission.
      Patients will be asked to stop the increase at a level of the current that they find highly
      annoying but not painful. The level of current that patients select during this trial
      procedure, and no higher level, will be used during the study so that they will not receive
      any painful electric shocks. The purpose of the electric shock is to create a situation in
      which emotional learning may occur. Patients will receive no more than ten of these electric
      shocks.

      Compensation is provided for clinical assessments and MRI scan sessions.
    

Intervention name(s): Transcranial Magnetic Stimulation
Intervention type(s): Device
Intervention description(s): Transcranial magnetic stimulation uses a rapidly changing magnetic field to induce current in brain tissue non-invasively. It is common procedure in both clinical and research settings, and it has well established guidelines for safe an ethical use which maximize safety for all subjects.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment