Study of Repetitive Transcranial Magnetic Stimulation Efficacy on Obsessive Compulsive Disorder (OCD) (TMS-TOC)
Device: Sham Comparator
|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|
- Yale-Brown Obsessive Compulsive Scale (YBOCS) [ Time Frame: week 1, 2, 3, 4, 5, 7, 9, 11, 13 ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||November 2008|
|Study Completion Date:||April 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
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.
|Placebo Comparator: 2||
Device: Sham Comparator
sham rTMS (using a placebo coil), 4 weeks of stimulation, will mimic the active treatment mentioned above.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00822601
|Pitie Salpetriere Hospital|
|Paris, France, 75013|
|Principal Investigator:||Antoine Pelissolo, MD, PhD||Assistance Publique - Hôpitaux de Paris|