Repetitive Transcranial Magnetic Stimulation in Obsessive Compulsive Disorder (MAGTOC)

May 7, 2020 updated by: University Hospital, Grenoble

Stimulation magnétique transcrânienne répétitive Dans le Traitement Des Troubles Obsessionnels Compulsifs

Evaluate the therapeutic effect of a functional Magnetic Resonance Imaging (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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Anticipated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Rhone Alpes
      • Grenoble, Rhone Alpes, France, 38000
        • Recruiting
        • CHU de Grenoble - Pavillon Dominique Villars
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Volunteer subjects with Obsessive Compulsive Disorders (OCD) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM IV-TR) criteria and validated by an experimented clinician following instruments like SCID (Structured Clinical Interview for DSM IV) or MINI (Mini-International Neuropsychiatric Interview)
  • with or without associated tics ("Gilles de la Tourette" Syndrome)
  • Age > 18 years old
  • Y-BOCS score > 20 and CGI (Clinical Global Impression Scale) score ≥ 4

  • Resistant patients to standard treatments - where treatment resistance is defined by partial but insufficient response (Global Assessment of Functioning score GAF score < 60 and/or reduction of Yale Brown Obsessions and Compulsion Scale score < 35%) or lack of response to previous well conducted treatment including:

    • pharmacotherapy : optimal tolerated dose and adequate duration (> 12 weeks) of at least 2 Serotonin Reuptake Inhibitors (selective serotonin reuptake inhibitors, clomipramine), and one augmentation strategy (adjunction of an antipsychotic - such as risperidone or olanzapine or aripiprazole - or lithium or buspirone) ;
    • psychotherapy (at least 6 months of cognitive and behavioral therapy)

Exclusion Criteria:

  • other primary diagnosis than OCD (comorbid tics and depression are tolerated)
  • comorbid diagnosis of schizophrenia/ psychotic disorder, bipolar disorder, substance abuse or dependance
  • medical condition involving cognitive decline and affecting brain structures such as Parkinson disease, dementia, multiple sclerosis, HIV (human immunodeficiency virus) infection, lupus etc.
  • Magnetic Resonance Imaging exclusion criteria (ferromagnetic implants etc)
  • common TMS exclusion criteria (neurological condition with an increased risk of seizure, cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, intracranial implants (e.g. cochlear implants, electrodes, aneurysm clips, stimulators... ) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed will be excluded
  • Current use of any investigational drug
  • pregnancy / breast feeding patients
  • visual or auditive important deficit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at baseline and at day 21

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At baseline, at day 21, day 90, day 180
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
At baseline, at day 21, day 90, day 180
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
At baseline, at day 21, day 90, day 180
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
for each session of Transcranial Magnetic Stimulation, at day 15, day 21, day 90, day 180
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.
at baseline (day 0)
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
at day 0 (baseline)
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.
day 15, day 90 and day 180 after the inclusion.
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
baseline - day 15 - day 21 - day 90 - day 180
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.
At baseline, at day 21, day 90, day 180
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
at baseline, day 15, day 21, day 90, day 180
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
for each session of Transcranial Magnetic Stimulation, at day 15, day 21, day 90, day 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Mircea POLOSAN, Professor, Institut National de la Santé Et de la Recherche Médicale, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

November 1, 2019

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

January 8, 2015

First Submitted That Met QC Criteria

August 30, 2016

First Posted (Estimate)

August 31, 2016

Study Record Updates

Last Update Posted (Actual)

May 8, 2020

Last Update Submitted That Met QC Criteria

May 7, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC14.156
  • 2014-A00668-39 (Other Identifier: ID RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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