Deep Brain Stimulation for Obsessive Compulsive Disorder (OCD PMCF)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Obsessive Compulsive Disorder

Intervention / Treatment
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* Device: Reclaim® Deep Brain Stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep Brain Stimulation Therapy for OCD<br>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<br>* Implant of leads in pre-defined brain area; implant of neurostimulators<br>|

What is the study measuring?
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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 |