Informations générales (source: ClinicalTrials.gov)
Stimulation magnétique transcrânienne répétitive Dans le Traitement Des Troubles Obsessionnels Compulsifs (MAGTOC)
Interventional
N/A
University Hospital, Grenoble (Voir sur ClinicalTrials)
mai 2015
mai 2021
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU de Grenoble - Pavillon Dominique Villars - 38000 - Grenoble - Rhone Alpes - France | POLOSAN Mircea, Professor | Contact (sur clinicalTrials) | |||
Critères
Tous
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)
- 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)
- 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