Obsessive-compulsive Disorders and Symptoms
Conditions
Keywords
Transcranial Direct Current Stimulation, Supplementary motor area, Orbitofrontal cortex
Brief summary
The purpose is to show that bifocal tDCS with an anodal stimulation on the orbitofrontal cortex and cathodic stimulation on supplementary motor areas is an effective treatment for patients with resistant and severe obsessive compulsive disorders.
Interventions
OTHERbifocal stimulation with tDCS
Patients will receive an active Treatment with tDCS (10 sessions of 30 mn with an intensity of 2 mA)
Sponsors
Centre Hospitalier Henri Laborit
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Patients must present all of the following criteria in order to be eligible: Inclusion Criteria: * Meets criteria for obsessive compulsive disorder according to DSM-IV with a "good insight" (BABS), * Age: Participants will be both males and females, 18-70 years of age included. * No current depressive and suicidal risks, * No epileptic pathology, * Chronic evolution ( Total Y-BOCS\>20 ), * Obsessive compulsive disorder resistant to pharmacology treatment, at least 2 antidepressants (type IRS) or cognitive and comportment therapy since at least one year, * Stability treatment (antidepressants) for more than 12 weeks without significant improvement, * Affiliation to a social security system (recipient or assignee), * Signed written inform consent form.
Exclusion criteria
* Female subject who is pregnant, or of child-bearing age, sexually active and not using reliable contraception or who is nursing, * Patient under curators * Meets another diagnosis of axe 1 of DSM-IV, * Current depressive or suicidal risks, * Patient with a benzodiazepine treatment, * Patient with any form of metal in the cranium, a pacemaker, skull defects, or skin lesions to the scalp (cuts, abrasions, rash) , * Epileptic patient, * Patient with a medical history of cranial trauma, * Patient unable to give his or hers informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome measure is used to show that bifocal tDCS with anodal stimulation on OFC and cathodic stimulation on the SMA is an effective treatment | Day 14 | Score improvement on the Y-BOCS after 14 days compared to the baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the persistence of therapeutic response at 45 days | Day 45 | Score improvement on the Y-BOCS after 45 days compared to the baseline |
| Evaluate the persistence of therapeutic response at 105 days | Day 105 | Score improvement on the Y-BOCS after 105 days compared to the baseline |
| Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 14 days | Day 14 | Score improvement of Hamilton and HDRS scales between the baseline and day 14 |
| Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 45 days | Day 45 | Score improvement of Hamilton and HDRS scales between the baseline and day 45 |
| Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 105 days | Day 105 | Score improvement of Hamilton and HDRS scales between the baseline and day 105 |
| Evaluate the effect of tDCS on the quality of life at day 14 | Day 14 | Improvement of MOS SF-36 scale (Medical Outcome Study, Short Form) between baseline and day 14 |
| Evaluate the effect of tDCS on the quality of life at day 45 | Day 45 | Improvement of MOS SF-36 scale (Medical Outcome Study, Short Form) between baseline and day 45 |
| Evaluate the effect of tDCS on global functioning at day 14 | Day 14 | Improvement of GAF (Global Assessment of Functioning) scale between baseline and day 14 |
| Evaluate the effect of tDCS on global functioning at day 45 | Day 45 | Improvement of GAF (Global Assessment of Functioning) scale between baseline and day 45 |
| Evaluate the effect of tDCS on social adjustment at day 14 | Day 14 | Improvement of SAS (Social Adjustment Scale) scale between baseline and day 14 |
| Evaluate the effect of tDCS on social adjustement at day 45 | Day 45 | Improvement of SAS (Social Adjustment Scale) scale between baseline and day 45 |
Countries
France
Contacts
STUDY_DIRECTORNematollah JAAFARI, Professor
Centre Hospitalier Henri Laborit
Outcome results
None listed