China Refractory Obsessive-Compulsive Disorder Deep Brain Stimulation Study
NCT ID: NCT02398318
Last Updated: 2016-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2/PHASE3
INTERVENTIONAL
2015-04-30
2018-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Bilateral Nucleus Accumbens DBS
6 month period of active bilateral nucleus accumbens DBS
Bilateral Nucleus Accumbens DBS (Suzhou Sceneray)
High frequency stimulation applied using Suzhou Sceneray® DBS hardware (1120 electrode, 1180 (S) battery).
Sham Bilateral Nucleus Accumbens DBS
6 month period of sham bilateral nucleus accumbens DBS
Sham Bilateral Nucleus Accumbens DBS
DBS system switched off.
Interventions
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Bilateral Nucleus Accumbens DBS (Suzhou Sceneray)
High frequency stimulation applied using Suzhou Sceneray® DBS hardware (1120 electrode, 1180 (S) battery).
Sham Bilateral Nucleus Accumbens DBS
DBS system switched off.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
60 Years
ALL
No
Sponsors
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Suzhou Sceneray Medical Co. , Ltd
INDUSTRY
National Natural Science Foundation of China
OTHER_GOV
Icahn School of Medicine at Mount Sinai
OTHER
Ruijin Hospital
OTHER
Responsible Party
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Bomin Sun
Director of functional neurosurgery department
Principal Investigators
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Bomin Sun, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital
Locations
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Guangzhou psychiatric hospital
Guangzhou, Guangdong, China
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
West China Hospital
Chengdu, Sichuan, China
Countries
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References
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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.
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.
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.
Related Links
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Related Info
Other Identifiers
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RCT-YY2015-CRODS
Identifier Type: -
Identifier Source: org_study_id