Repetitive Transcranial Magnetic Stimulation in Obsessive Compulsive Disorder (MAGTOC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02884674|
Recruitment Status : Recruiting
First Posted : August 31, 2016
Last Update Posted : May 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obsessive-Compulsive Disorder||Device: Active Repetitive Transcranial Magnetic Stimulation Device: Placebo Repetitive Transcranial Magnetic Stimulation||Not Applicable|
This study evaluates the therapeutic effect of a fMRI-guided and robotized neuronavigated theta burst Transcranial Magnetic Stimulation (TMS) targeting right inferior frontal region in resistant obsessive compulsive disorder (OCD) in a double-blind, randomized, placebo-controlled, monocentric study. The study will also assess the interest of some clinical, neuropsychological, neuroimaging, electrophysiological variables in response prediction, besides physiopathological information.
There is an increasing interest in developping treatments for resistant OCD, which are not responding to the conventional treatment, represented by pharmacotherapy associated to cognitive behavioral therapy. Repetitive TMS represents a promising non invasive brain stimulation approach, but efficacy, best available brain target, optimal responder profile and stimulation parameters need to be further documented.
In this study, the included patients will be randomly assigned to an active (theta burst TMS) or sham-placebo treatment group. TMS will be added to their stable pharmacotherapy. The brain target, the right inferior frontal region, involved in the inhibition control brain network, will be defined in a personalized manner via a fMRI paradigm for each patient. TMS will be delivered daily for 2 successive weeks. Measures of different clinical, neuropsychological , electrophysiological (cortical excitability) variables will be performed at baseline, as well as at the end of the TMS course, and 1 week after. Other assessments are planned at 3 and 6 months, in order to highlight the evolution of the potential benefit.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Stimulation magnétique transcrânienne répétitive Dans le Traitement Des Troubles Obsessionnels Compulsifs|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||May 2020|
Active Comparator: active Transcranial Magnetic Stimulation
Active Transcranial Magnetic Stimulation (TMS) targeting the right frontal inferior gyrus, 2 sessions per day, each session 5min30 day, during 10 consecutive days, Using theta burst stimulation and using Transcranial Magnetic Stimulation navigator and robot
Device: Active Repetitive Transcranial Magnetic Stimulation
modulation of the electrical activity of the right inferior frontal gyrus cortex in order to reduce Obsessive Compulsive Disorders symptoms by Active Transcranial Magnetic Stimulation (TMS) targeting the right frontal inferior gyrus, 2 sessions per day, each session 5min30 day, during 10 consecutive days, using theta burst stimulation and using a TMS neuronavigated robot
Placebo Comparator: Placebo
Placebo comparator, using non active magnetic coil, targeting the right frontal inferior gyrus, 2 sessions per day, each session 5min30 day, during 10 consecutive days, using theta burst stimulation and using Transcranial Magnetic Stimulation navigator and robot
Device: Placebo Repetitive Transcranial Magnetic Stimulation
Sham rTMS will be delivered using non active magnetic coil, targeting the right frontal inferior gyrus, 2 sessions per day, each session 5min30 day, during 10 consecutive days, using TMS neuronavigated robot. A subjective sensation will be obtained via frontal dermic electrical stimulation.
- Change from baseline of the score at the Yale - Brown Obsessive and Compulsive Scale [ Time Frame: at baseline and at day 21 ]Evaluation of Obsessive Compulsive Disorder symptoms using the Yale - Brown Obsessive and Compulsive Scale, at day 21, corresponding to 7 days after the end of the TMS cure, compared to baseline.
- Score of Montgomery and Asberg Depression Rating Scale, as a Measure of effects on Mood (depression) [ Time Frame: At baseline, at day 21, day 90, day 180 ]Evaluation of Mood using Montgomery Asberg Depression Rating Scale
- Score of Young Mania Rating Scale, as a Measure of effects on Mood (hyperthymia) [ Time Frame: At baseline, at day 21, day 90, day 180 ]Evaluation of Mood using Young Mania Rating Scale
- Score of Multidimensional Assessment of Thymic States Scale as a Measure of effects on Emotional Reactivity [ Time Frame: At baseline, at day 21, day 90, day 180 ]Evaluation of Emotional Reactivity using Multidimensional Assessment of Thymic States Scale
- Number of patients with Side effects as a measure of Safety and Tolerability [ Time Frame: for each session of Transcranial Magnetic Stimulation, at day 15, day 21, day 90, day 180 ]collection of the side effects of the Transcranial Magnetic Stimulation, after each session, during the entire TMS cure
- Inferior Frontal Region Activity (percentage of the BOLD signal change (parameter estimates beta) [ Time Frame: at baseline (day 0) ]
Performing a functional Magnetic Resonance Imaging, looking for biomarkers of response to the TMS cure.
Especially studying the right inferior cortex activation in functional Magnetic Resonance Imaging using a Signal Stop Task.
- Fractional Anisotropy (FA), mean and radial diffusivity (MD, RD), tracti integrity of the inhibition network, [ Time Frame: at day 0 (baseline) ]looking for anatomical biomarkers of response, or anatomical differences between the subjects on the inhibition network using Diffusing Tensor Imaging data
- Yale - Brown Obsessive and Compulsion Scale score after the TMS treatment as an evaluation of the persistence of the clinical benefit [ Time Frame: day 15, day 90 and day 180 after the inclusion. ]The Yale - Brown Obsessive and Compulsion Scale will also be performed at day 15, day 90 and day 180 after the inclusion in order to assess the kinetics of clinical changes in Obsessive Compulsive symptoms after the TMS cure.
- Cortical Excitability [ Time Frame: baseline - day 15 - day 21 - day 90 - day 180 ]assessing a new biomarker linked to OCD and monitoring its evolution with the TMS cure, testing its predictive value for the clinical response
- Evaluation of Impulsivity using specific scales [ Time Frame: At baseline, at day 21, day 90, day 180 ]Evaluation of impulsivity using UPPS (Urgency, Premeditation, and Sensation Seeking) Impulsive Behavior Scale.
- Evaluation of the Clinical global State [ Time Frame: at baseline, day 15, day 21, day 90, day 180 ]Using Clinical Global Impression scale we will assess the evolution of the clinical global status
- type of side effects (pain, paresthesia, other) as a measure of Safety and Tolerability [ Time Frame: for each session of Transcranial Magnetic Stimulation, at day 15, day 21, day 90, day 180 ]collection of the side effects of the Transcranial Magnetic Stimulation, after each session, during the entire TMS cure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02884674
|Contact: Mircea POLOSAN, Professorfirstname.lastname@example.org|
|CHU de Grenoble - Pavillon Dominique Villars||Recruiting|
|Grenoble, Rhone Alpes, France, 38000|
|Contact: POLOSAN Mircea, Professor email@example.com|
|Principal Investigator:||Mircea POLOSAN, Professor||Institut National de la Santé Et de la Recherche Médicale, France|