Deep Brain Stimulation for Obsessive Compulsive Disorder (OCD PMCF)
NCT ID: NCT01135745
Last Updated: 2018-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
32 participants
INTERVENTIONAL
2010-04-30
2015-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Reclaim® Deep Brain Stimulation
Implant of leads in pre-defined brain area; implant of neurostimulators
Interventions
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Reclaim® Deep Brain Stimulation
Implant of leads in pre-defined brain area; implant of neurostimulators
Eligibility Criteria
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Inclusion Criteria
* male and female patients at least 18 years of age
* diagnosis of Obsessive Compulsive Disorder
* meeting the definition of treatment resistance
Exclusion Criteria
* contraindication to implantation
* suicide risk
* risk of non-compliance
18 Years
ALL
No
Sponsors
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MedtronicNeuro
INDUSTRY
Responsible Party
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Principal Investigators
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Loes Gabriels, MD PhD MsEng
Role: PRINCIPAL_INVESTIGATOR
Professor of Psychiatry at UZ Leuven
Andreas Wahl-Kordon, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Lübeck
Ludger Tebartz van Elst, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Freiburg
Jose M Menchon, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Bellvitge Barcelona
Antonio Higueras, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Granada
Orsola Gambini, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital San Paolo Milan
Michael Schüpbach, MD
Role: PRINCIPAL_INVESTIGATOR
Insel Gruppe AG, University Hospital Bern
Siegried Kasper, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Psychiatry and Psychotherapy Medical University of Vienna
Diana Radu-Djurfeldt
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet, Stockholm
Renana Eitan
Role: PRINCIPAL_INVESTIGATOR
Hadassah-Hebrew University and Medical Center, Jerusalem
Locations
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Universitaire Ziekenhuis Leuven
Leuven, , Belgium
Universitätsklinikum Schleswig-Holstein Campus Lübeck
Lübeck, , Germany
Hadassah-Hebrew University Medical Center
Jerusalem, , Israel
A.O. San Paolo Polo Universitario
Milan, , Italy
Hospital Ciutat Sanitaria I Universitaria de Bellvitge
Barcelona, , Spain
Hospital Virgen de las Nieves
Granada, , Spain
Karolinska University Hospita
Stockholm, , Sweden
Inselspital Bern
Bern, , Switzerland
Countries
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References
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Rauch SL, Dougherty DD, Malone D, Rezai A, Friehs G, Fischman AJ, Alpert NM, Haber SN, Stypulkowski PH, Rise MT, Rasmussen SA, Greenberg BD. A functional neuroimaging investigation of deep brain stimulation in patients with obsessive-compulsive disorder. J Neurosurg. 2006 Apr;104(4):558-65. doi: 10.3171/jns.2006.104.4.558.
Other Identifiers
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OCD PMCF Study 1.02.7003
Identifier Type: -
Identifier Source: org_study_id
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