Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder
ConditionObsessive-Compulsive Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCentre Hospitalier Henri Laborit
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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),
Disqualifiers
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
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
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.
Female subject who is pregnant, or of child-bearing age, sexually active and not using reliable contraception or who is nursing,
Trial design
Design model
Parallel
Treatments tested in this trial
rTMS Treatment
Device1 Hz rTMS
Treatment groups
136 Participants
are divided into 2 treatment groupsGroup A: Active stimulationExperimental treatment 1 intervention
Group B: Sham StimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Yale Brown Obsessive Compulsive Scale score
Significant clinical change (≥ 25%) from baseline to two weeks after the treatment sequence, assessed by a significant reduction in YBOCS scores at day 25
Time frame
baseline and 25 daysSecondary outcomes
1
Yale Brown Obsessive Compulsive Scale
Significant clinical change of the YBOCS score (≥25% decrease), from baseline to day 70
Time frame
baseline and 70 days2
general assessement functioning (GAF)
Change of the general assessement functioning (GAF) at day 25
Time frame
baseline and 25 days3
general assessement functioning (GAF)
Change of the general assessement functioning (GAF) at day 70
Time frame
baseline and 70 days4
Clinical Global Impression (CGI)
Clinical Global Impressions (CGI) change at day 25
Time frame
baseline and 25 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov