Stimulation magnétique transcrânienne répétitive Dans le Traitement Des Troubles Obsessionnels Compulsifs
Repetitive Transcranial Magnetic Stimulation in Obsessive Compulsive Disorder
Sponsors
Source
University Hospital, Grenoble
Oversight Info
Has Dmc
Yes
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.
Overall Status
Recruiting
Start Date
2015-05-01
Completion Date
2020-05-01
Primary Completion Date
2017-11-01
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Change from baseline of the score at the Yale - Brown Obsessive and Compulsive Scale |
at baseline and at day 21 |
Secondary Outcome
Measure |
Time Frame |
|
Score of Montgomery and Asberg Depression Rating Scale, as a Measure of effects on Mood (depression) |
At baseline, at day 21, day 90, day 180 |
|
Score of Young Mania Rating Scale, as a Measure of effects on Mood (hyperthymia) |
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 |
At baseline, at day 21, day 90, day 180 |
|
Number of patients with Side effects as a measure of Safety and Tolerability |
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) |
at baseline (day 0) |
|
Fractional Anisotropy (FA), mean and radial diffusivity (MD, RD), tracti integrity of the inhibition network, |
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 |
day 15, day 90 and day 180 after the inclusion. |
|
Cortical Excitability |
baseline - day 15 - day 21 - day 90 - day 180 |
|
Evaluation of Impulsivity using specific scales |
At baseline, at day 21, day 90, day 180 |
|
Evaluation of the Clinical global State |
at baseline, day 15, day 21, day 90, day 180 |
|
type of side effects (pain, paresthesia, other) as a measure of Safety and Tolerability |
for each session of Transcranial Magnetic Stimulation, at day 15, day 21, day 90, day 180 |
Enrollment
56
Condition
Intervention
Intervention Type
Device
Intervention Name
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
Arm Group Label
active Transcranial Magnetic Stimulation
Intervention Type
Device
Intervention Name
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.
Arm Group Label
Placebo
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
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Mircea POLOSAN, Professor |
Principal Investigator |
Institut National de la Santé Et de la Recherche Médicale, France |
Overall Contact
Location
Facility |
Status |
Contact |
|
CHU de Grenoble - Pavillon Dominique Villars Grenoble Rhone Alpes 38000 France |
Recruiting |
Location Countries
Country
France
Verification Date
2018-05-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Secondary Id
2014-A00668-39
Number Of Arms
2
Arm Group
Arm Group Label
active Transcranial Magnetic Stimulation
Arm Group Type
Active Comparator
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
Arm Group Label
Placebo
Arm Group Type
Placebo Comparator
Description
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
Firstreceived Results Date
N/A
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Acronym
MAGTOC
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Study First Submitted
January 8, 2015
Study First Submitted Qc
August 30, 2016
Study First Posted
August 31, 2016
Last Update Submitted
May 9, 2018
Last Update Submitted Qc
May 9, 2018
Last Update Posted
May 15, 2018
ClinicalTrials.gov processed this data on August 27, 2018
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.