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A pilot study is recruiting
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| Name | Class |
|---|---|
| Suzhou Sceneray Medical Co. , Ltd | INDUSTRY |
| National Natural Science Foundation of China | OTHER_GOV |
| Icahn School of Medicine at Mount Sinai | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilateral Nucleus Accumbens DBS | Active Comparator | 6 month period of active bilateral nucleus accumbens DBS |
|
| Sham Bilateral Nucleus Accumbens DBS | Sham Comparator | 6 month period of sham bilateral nucleus accumbens DBS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral Nucleus Accumbens DBS (Suzhou Sceneray) | Device | High frequency stimulation applied using Suzhou Sceneray® DBS hardware (1120 electrode, 1180 (S) battery). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Score | Baseline (preoperative), 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bomin Sun, MD,PhD | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou psychiatric hospital | Guangzhou | Guangdong | 510370 | China | ||
| Shanghai Mental Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23443174 | Background | Zuo C, Ma Y, Sun B, Peng S, Zhang H, Eidelberg D, Guan Y. Metabolic imaging of bilateral anterior capsulotomy in refractory obsessive compulsive disorder: an FDG PET study. J Cereb Blood Flow Metab. 2013 Jun;33(6):880-7. doi: 10.1038/jcbfm.2013.23. Epub 2013 Feb 27. | |
| 22743198 | Background | Wu H, Van Dyck-Lippens PJ, Santegoeds R, van Kuyck K, Gabriels L, Lin G, Pan G, Li Y, Li D, Zhan S, Sun B, Nuttin B. Deep-brain stimulation for anorexia nervosa. World Neurosurg. 2013 Sep-Oct;80(3-4):S29.e1-10. doi: 10.1016/j.wneu.2012.06.039. Epub 2012 Jun 25. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 25, 2022 | |
| Reset | Oct 18, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 25, 2022 | Oct 18, 2023 |
| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| Sham Bilateral Nucleus Accumbens DBS | Device | DBS system switched off. |
|
|
| 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 |
| Shanghai |
| Shanghai Municipality |
| 200030 |
| China |
| West China Hospital | Chengdu | Sichuan | 610041 | China |
| 37243560 | Derived | Xiong B, Li B, Wen R, Gao Y, Gong F, Li D, Xu Y, Deng H, Xiao L, Yin S, Zhang W, Lozano AM, Wang W. Use of differential stimulation of the nucleus accumbens and anterior limb of the internal capsule to improve outcomes of obsessive-compulsive disorder. J Neurosurg. 2023 May 26;139(5):1376-1385. doi: 10.3171/2023.4.JNS221824. Print 2023 Nov 1. |