Deep Brain Stimulation for Obsessive Compulsive Disorder (OCD PMCF)
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| First Received Date ICMJE | May 5, 2010 | ||||||||||||||||||||||||||||||||
| Last Updated Date | September 19, 2012 | ||||||||||||||||||||||||||||||||
| Start Date ICMJE | April 2010 | ||||||||||||||||||||||||||||||||
| Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Characterization of Adverse Events related to implant procedures, device or stimulation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT01135745 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
To characterize improvement from baseline in OCD symptoms assessed by YBOCS. [ Time Frame: 12 months ] [ Designated as safety issue: No ] YBOCS score is taken at baseline and then at post-implant visits after 3, 6 and 12 months. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||||||||||||||
| Brief Title ICMJE | Deep Brain Stimulation for Obsessive Compulsive Disorder (OCD PMCF) | ||||||||||||||||||||||||||||||||
| Official Title ICMJE | Reclaim® Deep Brain Stimulation Therapy for Obsessive-Compulsive Disorder: Post-Market Clinical Follow-up Study (OCD PMCF) | ||||||||||||||||||||||||||||||||
| 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. |
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| 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 ICMJE | Interventional | ||||||||||||||||||||||||||||||||
| Study Phase | Phase 4 | ||||||||||||||||||||||||||||||||
| Study Design ICMJE | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Obsessive Compulsive Disorder | ||||||||||||||||||||||||||||||||
| Intervention ICMJE | Device: Reclaim® Deep Brain Stimulation
Implant of leads in pre-defined brain area; implant of neurostimulators |
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| Study Arm (s) | 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.
Intervention: Device: Reclaim® Deep Brain Stimulation |
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| 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. | ||||||||||||||||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||||||||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||||||||||||||||||||||
| Estimated Enrollment ICMJE | 32 | ||||||||||||||||||||||||||||||||
| Estimated Completion Date | May 2014 | ||||||||||||||||||||||||||||||||
| Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||||||||||||||||||
| Ages | 18 Years and older | ||||||||||||||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Austria, Belgium, Germany, Italy, Spain, Switzerland | ||||||||||||||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||||||||||||||
| NCT Number ICMJE | NCT01135745 | ||||||||||||||||||||||||||||||||
| Other Study ID Numbers ICMJE | OCD PMCF Study 1.02.7003 | ||||||||||||||||||||||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||||||||||||||||||||||
| Responsible Party | Medtronic International Trading Sarl | ||||||||||||||||||||||||||||||||
| Study Sponsor ICMJE | Medtronic International Trading Sarl | ||||||||||||||||||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | Medtronic International Trading Sarl | ||||||||||||||||||||||||||||||||
| Verification Date | September 2012 | ||||||||||||||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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