Deep Brain Stimulation for Obsessive Compulsive Disorder (OCD PMCF)

Reclaim® Deep Brain Stimulation Therapy for Obsessive-Compulsive Disorder: Post-Market Clinical Follow-up Study (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.

Study Overview

• Status: Completed
• Conditions: Obsessive Compulsive Disorder
• Intervention / Treatment: Device: Reclaim® Deep Brain Stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Universitaire Ziekenhuis Leuven
• Germany
  • Lübeck, Germany, 23538
    • Universitätsklinikum Schleswig-Holstein Campus Lübeck
• Israel
  • Jerusalem, Israel
    • Hadassah-Hebrew University Medical Center
• Italy
  • Milan, Italy, 20142
    • A.O. San Paolo Polo Universitario
• Spain
  • Barcelona, Spain, 08907
    • Hospital Ciutat Sanitaria I Universitaria de Bellvitge
  • Granada, Spain, 18014
    • Hospital Virgen de las Nieves
• Sweden
  • Stockholm, Sweden
    • Karolinska University Hospita
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To characterize improvement from baseline in OCD symptoms assessed by YBOCS.	YBOCS score is taken at baseline and then at post-implant visits after 3, 6 and 12 months.	12 months

Collaborators and Investigators

• Sponsor: MedtronicNeuro
• Investigators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (ACTUAL): May 1, 2015
• Study Completion (ACTUAL): May 1, 2015

Study Registration Dates

• First Submitted: May 5, 2010
• First Submitted That Met QC Criteria: May 31, 2010
• First Posted (ESTIMATE): June 3, 2010

Study Record Updates

• Last Update Posted (ACTUAL): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 18, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: OCD PMCF Study 1.02.7003