EFFI-STOC: STUDY OF THE EFFECTIVENESS OF TRANSCRANIAL DIRECT CURRENT STIMULATION ON OBSESSIVE COMPULSIVE DISORDER
Study Details
Study Description
Brief Summary
The usual management of Obsessive Compulsive Disorders is based on cognitive-behavioural psychotherapy, as well as the use of serotonergic antidepressants. Nevertheless, a significant proportion of patients (40% to 60%) are non-responders to these conventional therapies, and remain severely handicapped.
transcranial Direct current stimulation (tDCS) has already proven its effectiveness, in addition to drug approaches, in various clinical settings, such as depression or acoustic-verbal hallucinations. This technic appears to be an extremely interesting alternative This is a non-invasive neuromodulation technique (application of a low intensity direct current (1 to 2 mA) between two electrodes positioned on the scalp) that allows the neural activity of different brain areas to be modulated simultaneously. It is a simple and inexpensive technique with excellent tolerance.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Transcramial Direct current stimulation Implement of Transcramial Direct current stimulation |
Device: Transcramial Direct current stimulation
Two sessions of 5 stimulations will be made on patient with obsessive-compulsive disorder
|
| Placebo Comparator: Placebo
|
Device: Placebo
Two sessions of 5 stimulations will be made on patient with obsessive-compulsive disorder without direct current. They xwill just wear electrodes.
|
Outcome Measures
Primary Outcome Measures
- Yale-Brown's obsession-compulsion scale [3 month]
The evolution (continuous parameter) of this score between the beginning of treatment (Baseline BL) and the visit at 3 month will be calculated.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Presenting an obsessive-compulsive disorder according to the criteria of Diagnostic and Statistical Manual of Mental Disorders 5, evolving for at least two years
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Of significant clinical intensity: Yale-Brown's obsession-compulsion scale ≥ 16/40 continuously over the last 6 months. This criteria of persistent severity over the last 6 months will be explored by an in-depth clinical interview at the inclusion visit (Baseline BL)
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Resistant despite treatment with: 2 serotonergic antidepressants, each received for at least 8 weeks, at the maximum recommended or tolerated dosage AND behavioural and cognitive therapy for at least 6 months
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Drug treatment unchanged for at least 12 weeks
Exclusion Criteria:
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Patient with psychotic disorder, bipolar mood disorder, substance abuse or dependence (excluding tobacco)
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Patient at risk of suicide (score ≥ 2 on item 10 of the Montgomery-Åsberg depression rating scale)
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Contraindications to the practice of transcranial direct stimulation : history of cerebral pathology, intracranial hypertension, neurosurgery, cephalic metal implant, pacemaker
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Unbalanced epilepsy
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Previous use of transcranial direct stimulation (problem of maintaining the integrity of the blind procedure)
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Pregnancy or breastfeeding in progress, woman in a state of procreation without effective contraception (a urine pregnancy test will be performed)
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Scalp skin pathology
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU de Nice | Nice | France | 06003 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Nice
Investigators
- Principal Investigator: Bruno GIORDANA, MD, Centre Hospitalier Universitaire de Nice
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 16-API-02