Deep Brain Stimulation for Obsessive Compulsive Disorder (OCD PMCF)

Obsessive Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01135745
• Other study ID #: OCD PMCF Study 1.02.7003
• Status: Completed
• Phase: Phase 4
• First received: May 5, 2010
• Last updated: January 18, 2018
• Start date: April 2010
• Est. completion date: May 2015

Study information

• Verified date: January 2018
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder

Intervention

Device:
• Reclaim® Deep Brain Stimulation
Implant of leads in pre-defined brain area; implant of neurostimulators

Locations

Country	Name	City	State
Belgium	Universitaire Ziekenhuis Leuven	Leuven
Germany	Universitätsklinikum Schleswig-Holstein Campus Lübeck	Lübeck
Israel	Hadassah-Hebrew University Medical Center	Jerusalem
Italy	A.O. San Paolo Polo Universitario	Milan
Spain	Hospital Ciutat Sanitaria I Universitaria de Bellvitge	Barcelona
Spain	Hospital Virgen de las Nieves	Granada
Sweden	Karolinska University Hospita	Stockholm
Switzerland	Inselspital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Countries where clinical trial is conducted

Belgium,  Germany,  Israel,  Italy,  Spain,  Sweden,  Switzerland, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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