Deep Brain Stimulation for Obsessive Compulsive Disorder (OCD PMCF)
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.
Obsessive Compulsive Disorder
Device: Reclaim® Deep Brain Stimulation
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Reclaim® Deep Brain Stimulation Therapy for Obsessive-Compulsive Disorder: Post-Market Clinical Follow-up Study (OCD PMCF)|
- Characterization of Adverse Events related to implant procedures, device or stimulation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Prior to any other study procedures Adverse Events will be assessed at every study visit, i.e. after assessment at the baseline visit this will be implant visit, first parameter selection visit and regular visits after 3, 6, and 12 months treatment. AEs will also be collected at all unscheduled visits prior to all other assessments. AEs and stimulation effects will be categorized and recorded in the patient CRF. An independent clinical event committee will review and adjudicate AEs on a regular basis throughout the study.
- To characterize improvement from baseline in OCD symptoms assessed by YBOCS. [ Time Frame: 12 months ] [ Designated as safety issue: No ]YBOCS score is taken at baseline and then at post-implant visits after 3, 6 and 12 months.
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||May 2015|
|Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Experimental: Deep Brain Stimulation Therapy for OCD
Reclaim® DBS Therapy uses thin wires to deliver electric current (stimulation) to a very specific target in the brain. These wires are implanted surgically. They are attached to internal neurostimulators implanted under the skin of the chest below the collarbone, similar to cardiac pacemakers, or in the abdominal wall. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant.
Device: Reclaim® Deep Brain Stimulation
Implant of leads in pre-defined brain area; implant of neurostimulators
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 anxiety. The most frequent symptoms are contamination concerns with consequent washing or concerns about harm to self or others with consequent checking.
Although many OCD patients benefit from pharmacotherapy or CBT, between 7% and 10% of OCD patients fail to benefit from these standard treatments and may be considered treatment-resistant with a chronic deteriorating course. The most severely afflicted and disabled of these patients may be indicated for neurosurgical treatments, often considered as a therapy of last resort.
Neurosurgical procedures currently used in the treatment of severe, treatment-resistant OCD include anterior cingulotomy, subcaudate tractotomy, limbic leucotomy (which is a combination of the first two procedures) and anterior capsulotomy. The commonality between the different neurosurgical procedures is the irreversible lesioning of bilateral neuroanatomical structures and/or interconnecting pathways that are believed to be involved in the control of affect and limbic function.
An alternative neurosurgical treatment option to the standard lesioning procedures is Reclaim® Deep Brain Stimulation (DBS) Therapy for OCD, which received CE mark in July 2009.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01135745
|Universitaire Ziekenhuis Leuven|
|Leuven, Belgium, 3000|
|Universitätsklinikum Schleswig-Holstein Campus Lübeck|
|Lübeck, Germany, 23538|
|Hadassah-Hebrew University Medical Center|
|A.O. San Paolo Polo Universitario|
|Milan, Italy, 20142|
|Hospital Ciutat Sanitaria I Universitaria de Bellvitge|
|Barcelona, Spain, 08907|
|Hospital Virgen de las Nieves|
|Granada, Spain, 18014|
|Karolinska University Hospita|
|Bern, Switzerland, 3010|
|Principal Investigator:||Loes Gabriels, MD PhD MsEng||Professor of Psychiatry at UZ Leuven|
|Principal Investigator:||Andreas Wahl-Kordon, MD||University Hospital Lübeck|
|Principal Investigator:||Ludger Tebartz van Elst, MD||University Hospital Freiburg|
|Principal Investigator:||Jose M Menchon, MD||University Hospital Bellvitge Barcelona|
|Principal Investigator:||Antonio Higueras, MD||University Hospital Granada|
|Principal Investigator:||Orsola Gambini, MD||University Hospital San Paolo Milan|
|Principal Investigator:||Michael Schüpbach, MD||University Hospital Inselspital, Berne|
|Principal Investigator:||Siegried Kasper, MD||Department of Psychiatry and Psychotherapy Medical University of Vienna|
|Principal Investigator:||Diana Radu-Djurfeldt||Karolinska Institutet, Stockholm|
|Principal Investigator:||Renana Eitan||Hadassah-Hebrew University and Medical Center, Jerusalem|