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Deep Brain Stimulation for Obsessive Compulsive Disorder (OCD PMCF)

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ClinicalTrials.gov Identifier: NCT01135745
Recruitment Status : Completed
First Posted : June 3, 2010
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

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.

Condition or disease Intervention/treatment Phase
Obsessive Compulsive Disorder Device: Reclaim® Deep Brain Stimulation Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reclaim® Deep Brain Stimulation Therapy for Obsessive-Compulsive Disorder: Post-Market Clinical Follow-up Study (OCD PMCF)
Study Start Date : April 2010
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Characterization of Adverse Events related to implant procedures, device or stimulation [ Time Frame: 12 months ]
    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 :
  1. To characterize improvement from baseline in OCD symptoms assessed by YBOCS. [ Time Frame: 12 months ]
    YBOCS score is taken at baseline and then at post-implant visits after 3, 6 and 12 months.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01135745


Locations
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Belgium
Universitaire Ziekenhuis Leuven
Leuven, Belgium, 3000
Germany
Universitätsklinikum Schleswig-Holstein Campus Lübeck
Lübeck, Germany, 23538
Israel
Hadassah-Hebrew University Medical Center
Jerusalem, Israel
Italy
A.O. San Paolo Polo Universitario
Milan, Italy, 20142
Spain
Hospital Ciutat Sanitaria I Universitaria de Bellvitge
Barcelona, Spain, 08907
Hospital Virgen de las Nieves
Granada, Spain, 18014
Sweden
Karolinska University Hospita
Stockholm, Sweden
Switzerland
Inselspital Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
MedtronicNeuro
Investigators
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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:
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Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT01135745     History of Changes
Other Study ID Numbers: OCD PMCF Study 1.02.7003
First Posted: June 3, 2010    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
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Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders