Obsessive-Compulsive Disorder
Conditions
Keywords
rTMS, D-B80 A/P
Brief summary
According to the literature the lateral part of the Orbito Frontal Cortex (lOFC) is a relevant bilateral target for repetitive Trans-cranial Magnetic Stimulation (rTMS) in Obsessive Compulsive Disorder (OCD). Both hemispheres are concerned in terms of target.
Interventions
DEVICErTMS Treatment
1 Hz rTMS
Sponsors
Centre Hospitalier Henri Laborit
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age: Participants will be both males and females, 18-65 years of age included. * diagnosis of OCD * all the patients must have failed to respond to at least two different pharmacological treatment used for at least 6 weeks * Affiliation to a social security system (recipient or assignee), * Signed written inform consent form
Exclusion criteria
* The
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Yale Brown Obsessive Compulsive Scale score | baseline and 25 days | Significant clinical change (≥ 25%) from baseline to two weeks after the treatment sequence, assessed by a significant reduction in YBOCS scores at day 25 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Yale Brown Obsessive Compulsive Scale | baseline and 70 days | Significant clinical change of the YBOCS score (≥25% decrease), from baseline to day 70 |
| general assessement functioning (GAF) | baseline and 25 days | Change of the general assessement functioning (GAF) at day 25 |
| Clinical Global Impression (CGI) | baseline and 25 days | Clinical Global Impressions (CGI) change at day 25 |
| Adverse events linked to the rTMS treatment | 70 days | Number and types of adverse events linked to the rTMS treatment |
Countries
France
Contacts
Primary ContactGhina Harika-Germaneau, MD, PhD
Backup ContactNematollah Jaafari, PR
Outcome results
None listed