The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Obsessive-Compulsive Disorder

Study Overview
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Brief Summary
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The purpose of this clinical study is To verify the long term effectiveness and safety of a bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a treatment option for patients with cognitive, behavioral, and functional disability of Obsessive-Compulsive Disorder.

Official Title
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The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Obsessive-Compulsive Disorder

Conditions
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Obsessive-Compulsive Disorder

Intervention / Treatment
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* Device: Deep Brain Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obsessive compulsive disorder (according to DSM IV-criteria) as the primary psychiatric diagnosis. Severity level of OCD more than 25 on the Yale-Brown Obsessive Compulsive Scale. Course of illness had to have been present for at least five years in a chronic or progressive form despite any treatment trials (treatment resistance). Treatment resistance: at least two serotonin reuptake inhibitors (SSRI´s), or one SSRI and clomipramine in 5.Sufficient dosages for at least 10 weeks, an augmentation trial with lithium, buspirone or a neuroleptic Lasting at least 10 weeks, and complete cognitive-behavioral psychotherapy, including exposure and response Prevention of a minimum of 20 sessions with a documented lack of efficiency. 6.The ability to give written and informed consent. Exclusion Criteria: Co-morbid psychotic disorder according to DSM-IV criteria Suicidal tendencies in the last 6 months History of cerebral trauma Clinically relevant internal or neurological disorder Substance misuse or dependence in the last six months Ineligibility to fulfill the neurosurgical and anesthesiological preconditions for the implantation of a DBS Participate in other clinical trial The investigator and/or enrollment review committee, would preclude participation in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep Brain Stimulation<br>Stimulation is on. | Device: Deep Brain Stimulation<br> <br> * Other names: Implanted device;|
| Sham Comparator: Placebo<br>Stimulation is off. | Device: Deep Brain Stimulation<br> <br> * Other names: Implanted device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale-Brown obsessive-compulsive psychiatrists rating scale(Y-BOCS) |  | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton anxiety scale (HAMD) |  | 12 month |