Obsessive Compulsive Disorder
Conditions
Keywords
neurosurgery, deep brain stimulation, exposure response prevention
Brief summary
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.
Interventions
DEVICEBilateral Nucleus Accumbens DBS (Suzhou Sceneray)
High frequency stimulation applied using Suzhou Sceneray® DBS hardware (1120 electrode, 1180 (S) battery).
DEVICESham Bilateral Nucleus Accumbens DBS
DBS system switched off.
Sponsors
Suzhou Sceneray Medical Co. , Ltd
National Natural Science Foundation of China
Icahn School of Medicine at Mount Sinai
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 and 60 years. 2. A primary diagnosis of OCD, defined according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV). 3. Chronic: disease duration of more than 5 years. 4. 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. 5. Disability: a score on the Global Assessment Functioning (GAF) scale of less than 45. 6. 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
1. 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). 2. Cluster A or B personality disorder according to DSM-IV criteria, as assessed with the use of the Structured Clinical Interview II. 3. 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. 4. Abnormal cognitive status (measured by MoCA), abnormal findings on functional magnetic resonance imaging (MRI) of the brain; and no contraindications to surgery or anesthesia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Score | Baseline (preoperative), 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 positron emission tomography (PET) brain glucose metabolism images | Baseline (preoperative), 6 months after surgery | Fluoro-D-glucose (FDG) will be utilized to evaluate cerebral metabolism at Baseline (preoperative) and 6 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 Obsessive-Compulsive Inventory - Revised (OCI-R) Score | Baseline (preoperative), 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months | — |
| 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 | — |
| Change in functional magnetic resonance imaging (fMRI) images | Baseline (preoperative), 2 weeks after last ERP session (average) | — |
Countries
China
Outcome results
None listed