Status:
COMPLETED
Deep Brain Stimulation for Obsessive Compulsive Disorder (OCD PMCF)
Lead Sponsor:
MedtronicNeuro
Conditions:
Obsessive Compulsive Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to monitor the safety and performance of Reclaim® Deep Brain Stimulation (DBS) Therapy in patients with chronic, severe, treatment-resistant Obsessive Compulsive Disorder.
Detailed Description
OCD is an anxiety disorder characterized by intrusive thoughts or images (obsessions), which increase anxiety, commonly accompanied by repetitive or ritualistic actions (compulsions), which decrease a...
Eligibility Criteria
Inclusion
- signing and dating of Informed Consent
- male and female patients at least 18 years of age
- diagnosis of Obsessive Compulsive Disorder
- meeting the definition of treatment resistance
Exclusion
- Axis-I disorder primary to OCD
- contraindication to implantation
- suicide risk
- risk of non-compliance
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01135745
Start Date
April 1 2010
End Date
May 1 2015
Last Update
January 23 2018
Active Locations (8)
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1
Universitaire Ziekenhuis Leuven
Leuven, Belgium, 3000
2
Universitätsklinikum Schleswig-Holstein Campus Lübeck
Lübeck, Germany, 23538
3
Hadassah-Hebrew University Medical Center
Jerusalem, Israel
4
A.O. San Paolo Polo Universitario
Milan, Italy, 20142