Repetitive Transcranial Magnetic Stimulation in Obsessive Compulsive Disorder
NCT ID: NCT02884674
Last Updated: 2020-05-08
Study Results
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Basic Information
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UNKNOWN
NA
56 participants
INTERVENTIONAL
2015-05-31
2021-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
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
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
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.
Interventions
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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 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
* Current use of any investigational drug
* pregnancy / breast feeding patients
* visual or auditive important deficit
18 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Mircea POLOSAN, Professor
Role: PRINCIPAL_INVESTIGATOR
Institut National de la Santé Et de la Recherche Médicale, France
Locations
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CHU de Grenoble - Pavillon Dominique Villars
Grenoble, Auvergne-Rhône-Alpes, France
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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2014-A00668-39
Identifier Type: OTHER
Identifier Source: secondary_id
38RC14.156
Identifier Type: -
Identifier Source: org_study_id
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