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Refractory obsessive-compulsive disorder (OCD) is a disabling condition. Deep brain stimulation (DBS) of ventral capsule/ventral striatum(VC/VS) is potentially the most effective treatment for refractory OCD. However, the affecting area of traditional electrodes is limited and not specific to VC/VS. The investigators designed a novel electrode, 2 mental contacts(3mm contact-2mm space-3 mm contact) could be implanted in ventral striatum and the other upper 2 contacts(4mm space-3mm contact-4mm space-3mm contact)that can be implanted in ventral capsule simultaneously, which the investigators believe will be more effective due to better compatibly with anatomical features of target area. This trial is to evaluate the effectiveness and safety of this approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active stimulation | Active Comparator | Stimulator on followed by off |
|
| Sham stimulation | Sham Comparator | Stimulator off followed by on |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| deep brain stimulation system | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Score | Baseline (preoperative), 1 month, 3 months, 5 months, 6 months, 8 months, 12 months, 18 month, 24 month |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Obsessive-Compulsive Inventory - Revised (OCI-R) Score | Baseline (preoperative), 1 month, 3 months, 5 months, 6 months, 8 months, 12 months, 18 month, 24 month | |
| Adverse Events | Baseline (preoperative), 1 month, 3 months, 5 months, 6 months, 8 months, 12 months, 18 month, 24 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chencheng Zhang, MD | Contact | +8618217122884 | i@cczhang.com | |
| Chencheng Zhang, MD | Contact | +8618217122884 | i@cczhang.org |
| Name | Affiliation | Role |
|---|---|---|
| Bomin Sun, MD, PhD | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ruijin Hospital | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20116047 | Background | Goodman WK, Foote KD, Greenberg BD, Ricciuti N, Bauer R, Ward H, Shapira NA, Wu SS, Hill CL, Rasmussen SA, Okun MS. Deep brain stimulation for intractable obsessive compulsive disorder: pilot study using a blinded, staggered-onset design. Biol Psychiatry. 2010 Mar 15;67(6):535-42. doi: 10.1016/j.biopsych.2009.11.028. Epub 2010 Feb 8. | |
| 19005196 |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| Change in Hamilton Anxiety Scale, Hamilton Depression Scale-17 Score | Baseline (preoperative), 1 month, 3 months, 5 months, 6 months, 8 months, 12 months, 18 month, 24 month |
| Functional magnetic resonance imaging (fMRI) images | Baseline (preoperative) |
| Quality of life: Global assessment of function | Baseline (preoperative), 8 months, 12 months, 24 month |
| Disability: WHO disability assessment 2.0 | Baseline (preoperative), 8 months, 12 months, 24 month |
| Neurobehavior Task (Decision making task, such as Model task, IGT) | Baseline (preoperative), 8 months, 12 months, 24 month |
| Neurobehavior Task (Working memory task, such as N-back) | Baseline (preoperative), 8 months, 12 months, 24 month |
| Disability: Sheehan Disability Scale | Baseline (preoperative), 8 months, 12 months, 24 month |
| Change in Obsessional beliefs questionnaire (OBQ-44) Score | Baseline (preoperative), 1 month, 3 months, 5 months, 6 months, 8 months, 12 months, 18 month, 24 month |
| Change in Adult Temperament Questionnaire (ATQ-77) Score | Baseline (preoperative), 8 months, 12month, 24 month |
| Change in Temperament and Character Inventory Revised (TRI-R) Score | Baseline (preoperative), 8 months, 12month, 24 month |
| Cerebral glucose metabolism measured by PET-CT images | Baseline (preoperative), 12 month |
| Mallet L, Polosan M, Jaafari N, Baup N, Welter ML, Fontaine D, du Montcel ST, Yelnik J, Chereau I, Arbus C, Raoul S, Aouizerate B, Damier P, Chabardes S, Czernecki V, Ardouin C, Krebs MO, Bardinet E, Chaynes P, Burbaud P, Cornu P, Derost P, Bougerol T, Bataille B, Mattei V, Dormont D, Devaux B, Verin M, Houeto JL, Pollak P, Benabid AL, Agid Y, Krack P, Millet B, Pelissolo A; STOC Study Group. Subthalamic nucleus stimulation in severe obsessive-compulsive disorder. N Engl J Med. 2008 Nov 13;359(20):2121-34. doi: 10.1056/NEJMoa0708514. |
| 20921122 | Background | Denys D, Mantione M, Figee M, van den Munckhof P, Koerselman F, Westenberg H, Bosch A, Schuurman R. Deep brain stimulation of the nucleus accumbens for treatment-refractory obsessive-compulsive disorder. Arch Gen Psychiatry. 2010 Oct;67(10):1061-8. doi: 10.1001/archgenpsychiatry.2010.122. |