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Completed

NCT Number: NCT01135745

Deep Brain Stimulation for Obsessive Compulsive Disorder (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.

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Key information

Conditions

Obsessive Compulsive Disorder Anxiety Disorders Mental Disorders Obsessive-Compulsive Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Universitaire Ziekenhuis Leuven, Leuven, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reclaim® Deep Brain Stimulation

Device

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

MedtronicNeuro

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jun 3, 2010
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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