Deep Brain Stimulation for Obsessive Compulsive Disorder (OCD PMCF)

NCT01135745 | Completed Phase 4 DMC

• 1 other identifier: OCD PMCF Study 1.02.7003
• Study Type: interventional
• Target: 32
• Locations: 7 countries
• Sites: 8

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.

Conditions

Obsessive Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

• Characterization of Adverse Events related to implant procedures, device or stimulation

  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.

  12 months

Secondary Outcomes (1)

• To characterize improvement from baseline in OCD symptoms assessed by YBOCS.

  12 months

Study Arms (1)

Deep Brain Stimulation Therapy for OCD

EXPERIMENTAL

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

Interventions

Reclaim® Deep Brain Stimulation DEVICE

Implant of leads in pre-defined brain area; implant of neurostimulators

Deep Brain Stimulation Therapy for OCD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Axis-I disorder primary to OCD
• contraindication to implantation
• suicide risk
• risk of non-compliance

Sponsors & Collaborators

• MedtronicNeuro: lead

Study Sites (8)

Universitaire Ziekenhuis Leuven

Leuven, 3000, Belgium

Location

Universitätsklinikum Schleswig-Holstein Campus Lübeck

Lübeck, 23538, Germany

Location

Hadassah-Hebrew University Medical Center

Jerusalem, Israel

Location

A.O. San Paolo Polo Universitario

Milan, 20142, Italy

Location

Hospital Ciutat Sanitaria I Universitaria de Bellvitge

Barcelona, 08907, Spain

Location

Hospital Virgen de las Nieves

Granada, 18014, Spain

Location

Karolinska University Hospita

Stockholm, Sweden

Location

Inselspital Bern

Bern, 3010, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 16619660 BACKGROUND

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• 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

  Insel Gruppe AG, University Hospital Bern

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2010
• First Posted: June 3, 2010
• Study Start: April 1, 2010
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

CH (1); DE (1); IT (1); BE (1); IL (1); ES (2); SE (1)