ORBITOC3: Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Active stimulation Active rTMS stimulation , 2 session per day during 10 days. |
Device: rTMS Treatment
1 Hz rTMS
|
Sham Comparator: Sham Stimulation Sham rTMS stimulation , 2 session per day during 10 days. |
Device: rTMS Treatment
1 Hz rTMS
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
- general assessement functioning (GAF) [baseline and 70 days]
Change of the general assessement functioning (GAF) at day 70
- Clinical Global Impression (CGI) [baseline and 25 days]
Clinical Global Impressions (CGI) change at day 25
- Clinical Global Impression (CGI) [baseline and 70 days]
Clinical Global Impressions (CGI) change at day 70
- Adverse events linked to the rTMS treatment [70 days]
Number and types of adverse events linked to the rTMS treatment
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age: Participants will be both males and females, 18-65 years of age included.
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diagnosis of OCD
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all the patients must have failed to respond to at least two different pharmacological treatment used for at least 6 weeks
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Affiliation to a social security system (recipient or assignee),
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Signed written inform consent form
Exclusion Criteria:
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The exclusion criteria are a diagnosis of another psychiatric disorder (except for anxious disorders), a diagnosis of a significant active medical illness, pregnancy or other neurological illness
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In accordance with the safety criteria for rTMS, patients with a history of seizure or bearing pacemakers, mobile metal implants, implanted medical pumps, or metal clips placed inside the skull will also be excluded
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The patients won't be allowed to change their medication during the trial. The treatment must be stable at least 3 week before day 0.
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Female subject who is pregnant, or of child-bearing age, sexually active and not using reliable contraception or who is nursing,
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Patient under curators
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Patient hospitalized under duress
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Patient unable to give his or hers informed consent
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Sorbonne University, Pitié-Salpêtrière Hospital | Paris | France | ||
2 | Centre Hospitalier Henri Laborit | Poitiers | France | 86021 |
Sponsors and Collaborators
- Centre Hospitalier Henri Laborit
Investigators
- Study Director: Ghina Harika-Germaneau, Centre Hospitalier Henri Laborit
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2017-A02544-49