This is a multi-center, single arm, prospective, open-label, extendable study for the efficacy and safety of combo-stim deep brain stimulation for treatment-refractory mental disorders (obsessive-compulsive disorder, schizophrenia, bipolar with depression, anorexia nervosa, gambling disorder and adult autism).
Aged 18~65 when signing informed consent, outpatient or inpatient, male or female.
Fits DSM-5 obsessive-compulsive disorder criteria.
Aged 18~65 when signing informed consent, outpatient or inpatient, male or female.
Fits DSM-5 schizophrenia criteria.
With mental disorders including physical mental disorders, paranoid personality disorder, delayed mental development etc.
Through clinical evaluation by investigators, there exists significant suicide behavior risk.
Obsessive compulsive disorder: Y-BOCS score decreased (or improved) ≥ 20%
Schizophrenia: PANSS score decreased (or improved) ≥ 20%
Single group
deep brain stimulation
DeviceDBS electrodes will be implanted into the ALIC and the NAcc, electric stimulation of those areas are used to treat mental disorders and to evaluate the efficacy and safety of DBS system.
change of Y-BOCS score compared to baseline after 12 weeks of stimulation
change of Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score compared to baseline after 12 weeks of stimulation. The Y-BOCS is a test to rate the severity of obsessive-compulsive disorder (OCD) symptoms. Total of 10 items, total score is 40, minimum score is 0 (no symptom) , maximum score is 40 (extreme).
reduce rate of PANSS score compared to baseline after 12 weeks of stimulation
reduce rate of Positive and Negative Syndrome Scale (PANSS) score compared to baseline after 12 weeks of stimulation. The PANSS is a medical scale used for measuring symptom severity of patients with schizophrenia. Composed of three scles: The positive scale has 7 items (minimum score 7, maximum score 49), negative scale has 7 items (minimum score 7, maximum score 49), general psychopathology scale has 16 items (minimum score 16, maximum score 112). Together, PANSS total score minimum 30 (no symptom), maximum 210 (extreme).
change of Montgomery-Åsberg Depression Rating Scale (MADRS) score compared to baseline after 12 weeks of stimulation
change of Montgomery-Åsberg Depression Rating Scale (MADRS) score compared to baseline after 12 weeks of stimulation. The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Total score is 54, minimum score 0 (normal/symptom absent), maximum score 54 (severe).
change of BMI compared to baseline after 12 weeks of stimulation
change of BMI compared to baseline after 12 weeks of stimulation. Weight and height will be combined to report BMI in kg/m\^2.
Treatment efficacy rate in OCD
the number of treatment-response patient/total patient\*100% after 8/12/24 weeks of stimulation. The Y-BOCS score reduce rate ≥ 35% and Clinical Global Impression Scale (CGI-I) score being 1 or 2 means treatment response.
Change in Y-BOCS score compared to baseline after 8/24 weeks of stimulation. Change of Y-BOCS score in OCD
Change in Y-BOCS score compared to baseline after 8/24 weeks of stimulation. The Y-BOCS is a test to rate the severity of obsessive-compulsive symptoms. Total of 10 items, total score is 40, minimum score is 0 (no symptom) , maximum score is 40 (extreme).
Change of CGI-S score in OCD
Change in CGI-S score compared to baseline after 8/12/24 weeks of stimulation. The clinical global impression (CGI) rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders. It is composed of Severity of Illness (CGI-S) and Global Improvement (CGI-I). Item or total score is not available for both scales, minimum score 0 (no symptom), maximum score 7 (extreme).
Change of HAMD-17 score in OCD
Change in Hamilton Depression Scale (HAMD-17) score compared to baseline after 8/12/24 weeks of stimulation. This is a 17-item clinician-rated scale that is used to measure the severity of depression. Total score is 52, minimum socre is 0 (no symptom), maximum score is 52 (severe).
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Shanghai Mental Health Center
Lead sponsor
SceneRay Corporation, Limited
Collaborator
Huashan Hospital
Collaborator
Shanghai 6th People's Hospital
Collaborator
Changhai Hospital
Collaborator
