China Refractory Obsessive-Compulsive Disorder Deep Brain Stimulation Study

Study Overview
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Brief Summary
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Refractory obsessive-compulsive disorder (OCD) is a disabling condition. Deep brain stimulation (DBS) of the nucleus accumbens is the most tested therapeutic avenue for refractory OCD. However, large scale randomized controlled trials to evaluate the effectiveness of this approach are rare.

Official Title
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China Refractory-Obsessive Compulsive Disorder Deep Brain Stimulation Study

Conditions
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Obsessive Compulsive Disorder

Intervention / Treatment
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* Device: Bilateral Nucleus Accumbens DBS (Suzhou Sceneray)
* Device: Sham Bilateral Nucleus Accumbens DBS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 60 years. A primary diagnosis of OCD, defined according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV). Chronic: disease duration of more than 5 years. Severity: a score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) of more than 25 or one subscale score of more than 15 ; a score for severity of illness on the Clinical Global Impression (CGI) scale of more than 4. Disability: a score on the Global Assessment Functioning (GAF) scale of less than 45. Refractory: a lack of response to drug therapy after adequate administration (defined as more than 12 weeks at the maximum tolerated dose) of at least three serotonin-reuptake inhibitors, one of which had to be clomipramine. Adequate behavior therapy, defined as 20 sessions of exposure and response prevention (ERP) with a therapist who has substantial expertise in OCD treatment. Exclusion Criteria: Schizophrenic disorder; bipolar disorder; substance abuse or dependence (except for dependence on nicotine), as assessed with the use of the Mini-International Neuropsychiatric Interview (MINI 6.0.0). Cluster A or B personality disorder according to DSM-IV criteria, as assessed with the use of the Structured Clinical Interview II. A current severe major depressive episode, determined according to DSM-IV criteria (as assessed with the use of the MINI 6.0.0) and defined by the Hamilton Depression Rating Scale-17 (HAMD) score of more than 20 and a risk of suicide. Abnormal cognitive status (measured by MoCA), abnormal findings on functional magnetic resonance imaging (MRI) of the brain; and no contraindications to surgery or anesthesia.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bilateral Nucleus Accumbens DBS<br>6 month period of active bilateral nucleus accumbens DBS | Device: Bilateral Nucleus Accumbens DBS (Suzhou Sceneray)<br>* High frequency stimulation applied using Suzhou Sceneray® DBS hardware (1120 electrode, 1180 (S) battery).<br>* Other names: Active DBS;|
| Sham Comparator: Sham Bilateral Nucleus Accumbens DBS<br>6 month period of sham bilateral nucleus accumbens DBS | Device: Sham Bilateral Nucleus Accumbens DBS<br>* DBS system switched off.<br>* Other names: Sham DBS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Score |  | Baseline (preoperative), 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Obsessive-Compulsive Inventory - Revised (OCI-R) Score |  | Baseline (preoperative), 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months | 
| Change in Hamilton Anxiety Scale, Hamilton Depression Scale-17, Beck Anxiety Scale, Beck Depression Scale-1 Score |  | Baseline (preoperative), 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months | 
| Change in Temperament and Character Inventory revised version (TCI-R) Score |  | Baseline (preoperative), 6 months, 24 months | 
| Iowa Gambling Task (change in task performance scores) |  | Baseline (preoperative), 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months | 
| Change in functional magnetic resonance imaging (fMRI) images |  | Baseline (preoperative), 2 weeks after last ERP session (average) | 
| Change in positron emission tomography (PET) brain glucose metabolism images | Fluoro-D-glucose (FDG) will be utilized to evaluate cerebral metabolism at Baseline (preoperative) and 6 months. | Baseline (preoperative), 6 months after surgery | 
| Quality of life: Global assessment of function |  | Baseline (preoperative), 2 weeks after last ERP session (average), 6 months after surgery, 24 months after surgery | 
| Disability: WHO disability assessment 2.0 |  | Baseline (preoperative), 2 weeks after last ERP session (average), 6 months after surgery, 24 months after surgery | 
| Model Task (change in task performance scores) |  | Baseline (preoperative), 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neurosurgery, deep brain stimulation, exposure response prevention