Study of Repetitive Transcranial Magnetic Stimulation Efficacy on Obsessive Compulsive Disorder (OCD) (TMS-TOC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00822601
First received: January 13, 2009
Last updated: July 30, 2012
Last verified: January 2009
  Purpose

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


Condition Intervention Phase
Obsessive-Compulsive Disorder
Device: rTMS
Device: Sham Comparator
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Controlled Study of rTMS Over Supplementary Motor Area (SMA) in Obsessive Compulsive Disorder

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Yale-Brown Obsessive Compulsive Scale (YBOCS) [ Time Frame: week 1, 2, 3, 4, 5, 7, 9, 11, 13 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression - Severity (CGI-S) [ Time Frame: week 1, 2, 3, 4, 5, 7, 9, 11, 13 ] [ Designated as safety issue: No ]
  • - Clinical Global Impression - Improvement (CGI-I) [ Time Frame: week 1, 2, 3, 4, 5, 7, 9, 11, 13 ] [ Designated as safety issue: No ]
  • Global Assessment of Functioning (GAF) [ Time Frame: week 5, 13 ] [ Designated as safety issue: No ]
  • - Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: week 5, 13 ] [ Designated as safety issue: No ]
  • Brief Anxiety Scale (BAS [ Time Frame: week 5, 13 ] [ Designated as safety issue: No ]
  • Sheehan Disability Scale (SDS) [ Time Frame: , week 5, 13 ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression (HAD) scale [ Time Frame: week 1, 2, 3, 4, 5, 7, 9, 11, 13 ] [ Designated as safety issue: No ]
  • Maudsley Obsessional Inventory (MOCI) [ Time Frame: week 5, 13 ] [ Designated as safety issue: No ]
  • LPO scale [ Time Frame: week 5, 13 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: November 2008
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: rTMS
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.
Other Name: rTMS
Placebo Comparator: 2 Device: Sham Comparator
sham rTMS (using a placebo coil), 4 weeks of stimulation, will mimic the active treatment mentioned above.
Other Name: Sham Comparator

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • signed patient informed consent;
  • primary obsessive compulsive disorder;
  • current YBOCS score at least 15 with or without drug (or obsessive/compulsive subscores of at least 10);
  • males/females 18-65yrs;
  • treated with at least two adequate dose of SRI at least 8 weeks at some stage of illness;
  • currently using adequate, stable dose of SSRI at least 8 weeks but not responding.

Exclusion Criteria:

  • schizophrenia, other psychotic disorders, bipolar I, current major depressive disorder (MADRS>20), substance/alcohol dependence within last 6 months;
  • severe axis II;
  • significant suicide risk;
  • metallic implant in cranium;
  • severe/unstable medical conditions;
  • ECT in the last month;
  • pregnancy or breastfeeding ;
  • history epilepsy; neurological disorder leading to increased intracranial pressure; severe cardiac disorder/intracardiac lines, pacemakers; Gilles de la Tourette syndrome;
  • current structured psychotherapy;
  • current drug treatment of bipolar disorder.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00822601

Locations
France
Pitie Salpetriere Hospital
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Antoine Pelissolo, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00822601     History of Changes
Other Study ID Numbers: AOR07067
Study First Received: January 13, 2009
Last Updated: July 30, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Repetitive Transcranial Magnetic Stimulation
Supplementary Motor Area
Obsessive-Compulsive Disorder
Sham rTMS
Placebo-controlled
Randomized
Double-blind
fMRI
DSM-IV Obsessive-Compulsive Disorder

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders

ClinicalTrials.gov processed this record on July 31, 2014