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Repetitive Transcranial Magnetic Stimulation in Obsessive Compulsive Disorder (MAGTOC)

Primary Purpose

Obsessive-Compulsive Disorder

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Active Repetitive Transcranial Magnetic Stimulation

Placebo Repetitive Transcranial Magnetic Stimulation

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring Obsessive-Compulsive Disorder, Transcranial Magnetic Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU de Grenoble - Pavillon Dominique VillarsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

active Transcranial Magnetic Stimulation

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from baseline of the score at the Yale - Brown Obsessive and Compulsive Scale

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.

Secondary Outcome Measures

Score of Montgomery and Asberg Depression Rating Scale, as a Measure of effects on Mood (depression)

Evaluation of Mood using Montgomery Asberg Depression Rating Scale

Score of Young Mania Rating Scale, as a Measure of effects on Mood (hyperthymia)

Evaluation of Mood using Young Mania Rating Scale

Score of Multidimensional Assessment of Thymic States Scale as a Measure of effects on Emotional Reactivity

Evaluation of Emotional Reactivity using Multidimensional Assessment of Thymic States Scale

Number of patients with Side effects as a measure of Safety and Tolerability

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)

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,

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

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

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

Evaluation of impulsivity using UPPS (Urgency, Premeditation, and Sensation Seeking) Impulsive Behavior Scale.

Evaluation of the Clinical global State

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

collection of the side effects of the Transcranial Magnetic Stimulation, after each session, during the entire TMS cure

Full Information

NCT ID

NCT02884674

First Posted

January 8, 2015

Last Updated

May 7, 2020

Sponsor

University Hospital, Grenoble

1. Study Identification

Unique Protocol Identification Number

NCT02884674

Brief Title

Repetitive Transcranial Magnetic Stimulation in Obsessive Compulsive Disorder

Acronym

MAGTOC

Official Title

Stimulation magnétique transcrânienne répétitive Dans le Traitement Des Troubles Obsessionnels Compulsifs

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Unknown status

Study Start Date

May 2015 (undefined)

Primary Completion Date

November 2019 (Actual)

Study Completion Date

May 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Grenoble

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obsessive-Compulsive Disorder

Keywords

Obsessive-Compulsive Disorder, Transcranial Magnetic Stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

active Transcranial Magnetic Stimulation

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Active Repetitive Transcranial Magnetic Stimulation

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Placebo Repetitive Transcranial Magnetic Stimulation

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change from baseline of the score at the Yale - Brown Obsessive and Compulsive Scale

Description

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.

Time Frame

at baseline and at day 21

Secondary Outcome Measure Information:

Title

Score of Montgomery and Asberg Depression Rating Scale, as a Measure of effects on Mood (depression)

Description

Evaluation of Mood using Montgomery Asberg Depression Rating Scale

Time Frame

At baseline, at day 21, day 90, day 180

Title

Score of Young Mania Rating Scale, as a Measure of effects on Mood (hyperthymia)

Description

Evaluation of Mood using Young Mania Rating Scale

Time Frame

At baseline, at day 21, day 90, day 180

Title

Score of Multidimensional Assessment of Thymic States Scale as a Measure of effects on Emotional Reactivity

Description

Evaluation of Emotional Reactivity using Multidimensional Assessment of Thymic States Scale

Time Frame

At baseline, at day 21, day 90, day 180

Title

Number of patients with Side effects as a measure of Safety and Tolerability

Description

collection of the side effects of the Transcranial Magnetic Stimulation, after each session, during the entire TMS cure

Time Frame

for each session of Transcranial Magnetic Stimulation, at day 15, day 21, day 90, day 180

Title

Inferior Frontal Region Activity (percentage of the BOLD signal change (parameter estimates beta)

Description

Time Frame

at baseline (day 0)

Title

Fractional Anisotropy (FA), mean and radial diffusivity (MD, RD), tracti integrity of the inhibition network,

Description

looking for anatomical biomarkers of response, or anatomical differences between the subjects on the inhibition network using Diffusing Tensor Imaging data

Time Frame

at day 0 (baseline)

Title

Yale - Brown Obsessive and Compulsion Scale score after the TMS treatment as an evaluation of the persistence of the clinical benefit

Description

Time Frame

day 15, day 90 and day 180 after the inclusion.

Title

Cortical Excitability

Description

assessing a new biomarker linked to OCD and monitoring its evolution with the TMS cure, testing its predictive value for the clinical response

Time Frame

baseline - day 15 - day 21 - day 90 - day 180

Title

Evaluation of Impulsivity using specific scales

Description

Evaluation of impulsivity using UPPS (Urgency, Premeditation, and Sensation Seeking) Impulsive Behavior Scale.

Time Frame

At baseline, at day 21, day 90, day 180

Title

Evaluation of the Clinical global State

Description

Using Clinical Global Impression scale we will assess the evolution of the clinical global status

Time Frame

at baseline, day 15, day 21, day 90, day 180

Title

type of side effects (pain, paresthesia, other) as a measure of Safety and Tolerability

Description

collection of the side effects of the Transcranial Magnetic Stimulation, after each session, during the entire TMS cure

Time Frame

for each session of Transcranial Magnetic Stimulation, at day 15, day 21, day 90, day 180

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mircea POLOSAN, Professor

mpolosan@chu-grenoble.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mircea POLOSAN, Professor

Organizational Affiliation

Institut National de la Santé Et de la Recherche Médicale, France

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU de Grenoble - Pavillon Dominique Villars

City

Grenoble

State/Province

Rhone Alpes

ZIP/Postal Code

38000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

POLOSAN Mircea, Professor

mpolosan@chu-grenoble.fr

12. IPD Sharing Statement

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Repetitive Transcranial Magnetic Stimulation in Obsessive Compulsive Disorder

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