Trial record 2 of 24 for:    deep brain stimulation OCD

Deep Brain Stimulation for Obsessive Compulsive Disorder (OCD PMCF)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Medtronic International Trading Sarl Identifier:
First received: May 5, 2010
Last updated: April 10, 2015
Last verified: April 2015

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.

Condition Intervention Phase
Obsessive Compulsive Disorder
Device: Reclaim® Deep Brain Stimulation
Phase 4

Study Type: Interventional
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)

Resource links provided by NLM:

Further study details as provided by Medtronic International Trading Sarl:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 36
Study Start Date: April 2010
Estimated Study Completion Date: May 2015
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • Axis-I disorder primary to OCD
  • contraindication to implantation
  • suicide risk
  • risk of non-compliance
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01135745

Universitaire Ziekenhuis Leuven
Leuven, Belgium, 3000
Universitätsklinikum Schleswig-Holstein Campus Lübeck
Lübeck, Germany, 23538
Hadassah-Hebrew University Medical Center
Jerusalem, Israel
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
Stockholm, Sweden
Inselspital Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
Medtronic International Trading Sarl
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
  More Information

Responsible Party: Medtronic International Trading Sarl Identifier: NCT01135745     History of Changes
Other Study ID Numbers: OCD PMCF Study 1.02.7003
Study First Received: May 5, 2010
Last Updated: April 10, 2015
Health Authority: Austria: Ethikkommission
Austria: Agency for Health and Food Safety
Belgium: Ethics Committee
Germany: Ethics Commission
Italy: Ethics Committee
Spain: Ethics Committee
Switzerland: Ethikkommission
Sweden: Regional Ethical Review Board
Israel: Ethics Commission

Additional relevant MeSH terms:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders processed this record on October 07, 2015