Study of Repetitive Transcranial Magnetic Stimulation Efficacy on Obsessive Compulsive Disorder (OCD)
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Our study's purpose is to show the efficacy of the transcranial magnetic stimulation (a non
      invasive method of cerebral modulation) in patients suffering from chronic obsessive
      compulsive disorder (OCD). This new method will be applied in 20 patients during 4 weeks (5
      sessions each week), and its effects on OCD symptoms will be compared to those of a "sham"
      (=placebo) stimulation applied with the same process in 20 other patients, randomly assigned
      to the comparison group. The maintenance of the therapeutic effects will be explored during 8
      weeks following the end of the treatment. In addition to classical scales used to measure the
      treatment effects, all patients will be examined using a functional magnetic resonance
      imaging (fMRI) before and after treatment to explore the cerebral effects of rTMS
    

Detailed description: 
      Repetitive Transcranial Magnetic Stimulation (rTMS) has been shown to be an effective
      therapeutic tool for the treatment of several neuropsychiatric disorders including major
      depression and hallucinations in schizophrenia but, to date, studies exploring the effects of
      rTMS in Obsessive Compulsive Disorder (OCD) have produce negative or conflicting results,
      especially those applying the stimulation to the prefrontal cortex as for the treatment of
      depression. However, a promising result has been obtained in a study in which the rTMS was
      applied to the Supplementary Motor Area (SMA), but in a small size and heterogeneous sample.
      The SMA has connections with areas of the brain, especially motor areas and
      subcortical-limbic circuitry, implicated in OCD.

      In our study, 40 adult outpatients with OCD, who have been insufficiently responsive to at
      least two recognized drug treatments, will be randomly assigned to one of two treatment
      groups (active low frequency (1 Hz, 100% of the motor threshold) rTMS or sham-placebo)
      applied to the SMA daily for up to four weeks. An individual MRI-guided neuronavigation will
      be used to precisely define the target stimulation site in each patient. Rating scales for
      symptom change will be obtained at baseline, during the rTMS course, at the end of 4 weeks of
      treatment, and after a 2-month follow-up period. The main outcome measure will be the
      Yale-Brown Obsessive Compulsive scale, and secondary outcome measure will include the CGI
      scales, the LPO scale, the MOCI, and the SDS. Brain activity changes in fMRI before and after
      active/sham treatment will be compared between groups, with rest measures and provocation
      tasks.
    

Intervention name(s): rTMS; Sham Comparator
Intervention type(s): Device; Device
Intervention description(s): Arm 1 (experimental) : rTMS, 4 weeks of stimulation with RMT frequency 1Hz, intensity 100% of RMT for 20 minutes (1500 pulses), 5 minutes of trains with 2 minutes of intra-train intervals to both SMA. Treatment will be given 5 times a week for 4 weeks.; sham rTMS (using a placebo coil), 4 weeks of stimulation, will mimic the active treatment mentioned above.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Repetitive Transcranial Magnetic Stimulation; Supplementary Motor Area; Obsessive-Compulsive Disorder; Sham rTMS; Placebo-controlled; Randomized; Double-blind; fMRI; DSM-IV Obsessive-Compulsive Disorder