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NCT01879254 Clinical Trial

Long-term Follow-up in Patients With Deep Brain Stimulation (DBS) for Obsessive Compulsive Disorder (OCD).

Obsessive Compulsive Disorder (OCD) Clinical Trial

Official title:
Long-term Follow-up in Patients With Deep Brain Stimulation (DBS) for Severe Treatment Refractory Obsessive Compulsive Disorder (OCD).

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01879254
Other study ID # s50928
Secondary ID
Status Recruiting
Phase N/A
First received June 12, 2013
Last updated January 26, 2016
Start date February 2008

Study information
Verified date January 2016
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health Products
Study type Observational

Clinical Trial Summary

For this human research, 17 treatment-refractory OCD patients who already received DBS implants for treatment refractory OCD between June 1998 and October 2007 will be included. New patients that complete the protocol on "refining the target for DBS in OCD" will be included in this follow-up study as well. They will be psychiatrically evaluated on regular bases: at least twice yearly in the years two to five after surgery, at least once a year for the years thereafter. The duration of this protocol is indefinite, but spans at least 10 years. The main aim of this study is to investigate the long-term effect of DBS in OCD patients.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Patients who have received DBS implantation for the treatment of OCD

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• Deep Brain Stimulation

Locations
Country Name City State
Belgium UZ Leuven Leuven Vlaams-Brabant

Sponsors (1)
Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Yale-Brown Obsessive Compulsive Scale (Y-BOCS) up to 10 years No
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