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Study 11 of 628 for search of: | received on or after 12/30/2008 |
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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00822601 |
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 |
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Obsessive-Compulsive Disorder |
Device: rTMS Device: Sham Comparator |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Controlled Study of rTMS Over Supplementary Motor Area (SMA) in Obsessive Compulsive Disorder |
Estimated Enrollment: | 40 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
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.
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2: Placebo Comparator |
Device: Sham Comparator
sham rTMS (using a placebo coil), 4 weeks of stimulation, will mimic the active treatment mentioned above.
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Antoine Pelissolo, MD, PhD | +33 1 42 16 12 44 | antoine.pelissolo@upmc.fr |
France | |
Pitie Salpetriere Hospital | Recruiting |
Paris, France, 75013 | |
Contact: Antoine Pelissolo, MD, PhD +33 1 42 16 12 44 antoine.pelissolo@upmc.fr | |
Principal Investigator: Antoine Pelissolo, MD, PhD |
Principal Investigator: | Antoine Pelissolo, MD, PhD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Clinical Research Department of Developpement ( Cécile JOURDAIN ) |
Study ID Numbers: | AOR07067 |
Study First Received: | January 13, 2009 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00822601 |
Health Authority: | France: Ministry of Health |
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