Repetitive Transcranial Magnetic Stimulation in Obsessive Compulsive Disorder

NCT02884674 | Unknown DMC

• 2 other identifiers: 38RC14.1562014-A00668-39
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-Compulsive Disorder

Keywords

Obsessive-Compulsive Disorder; Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

• 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.

  at baseline and at day 21

Secondary Outcomes (11)

• 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)

Study Arms (2)

active Transcranial Magnetic Stimulation

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Active Repetitive Transcranial Magnetic Stimulation DEVICE

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

active Transcranial Magnetic Stimulation

Placebo Repetitive Transcranial Magnetic Stimulation DEVICE

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• Current use of any investigational drug
• pregnancy / breast feeding patients
• visual or auditive important deficit

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHU de Grenoble - Pavillon Dominique Villars

Grenoble, Auvergne-Rhône-Alpes, 38000, France

RECRUITING

Related Publications (34)

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MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Mircea POLOSAN, Professor

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mircea POLOSAN, Professor

CONTACT

mpolosan@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: August 31, 2016
• Study Start: May 1, 2015
• Primary Completion: November 1, 2019
• Study Completion: May 1, 2021
• Last Updated: May 8, 2020

Record last verified: 2020-05

Locations

FR (1)