Actively Recruiting
Efficacy and Safety of Combo-stim Deep Brain Stimulation for Treatment-refractory Mental Disorders
Led by Shanghai Mental Health Center · Updated on 2025-05-18
18
Participants Needed
1
Research Sites
145 weeks
Total Duration
On this page
Sponsors
S
Shanghai Mental Health Center
Lead Sponsor
S
SceneRay Corporation, Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Efficacy and Safety of Combo-stim Deep Brain Stimulation for Treatment-refractory Mental Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years at signing informed consent, male or female, outpatient or inpatient.
- Diagnosis of obsessive-compulsive disorder, schizophrenia, bipolar depression, anorexia nervosa, gambling disorder, or adult autism according to DSM-5 criteria.
- Condition must be treatment refractory as defined by specific medication and therapy history for each disorder.
- For obsessive-compulsive disorder: Y-BOCS score of 25 or higher and CGI-S score of 4 or higher.
- For schizophrenia: PANSS score of 70 or higher, with specific symptom criteria; CGI-S score of 4 or higher; GAF score of 60 or lower.
- For bipolar depression: depression episode lasting 12 weeks or more; MADRS score of 26 or higher; GCI-BP score of 4 or higher; YMRS score of 12 or higher.
- For anorexia nervosa: BMI between 10 and less than 16; severe and sustained illness lasting 5 years or more with repeated inpatient history and poor treatment effect.
- For gambling disorder: course of disorder 2 years or more; meets medium or severe DSM-5 diagnostic criteria; ongoing symptoms despite treatment.
- For adult autism: AuBC score of 62 or higher; CGI-S score of 4 or higher; course of disorder 10 years or more with failed or intolerant behavioral interventions.
- Patient and guardian agree to DBS implant and provide informed consent after understanding the study.
You will not qualify if you...
- Presence of other mental disorders such as physical mental disorders, paranoid personality disorder, or delayed mental development.
- Significant suicide risk as assessed by investigators.
- Significant clinical improvement in condition scores during screening to baseline period.
- Severe or unstable cardiovascular, respiratory, liver, kidney, blood, endocrine, nervous system, or other systemic disorders.
- Neurological disorders including brain trauma, refractory seizures, or physical brain disorders.
- Clinically significant abnormalities in physical exam, lab tests, ECG, or imaging during screening or baseline.
- Presence of implanted cochlear devices, pacemakers, or recent surgeries affecting study participation.
- Contraindications to DBS implant surgery as determined by investigators.
- HIV positive diagnosis.
- Female participants who are pregnant, breastfeeding, or unable to use effective contraception during the study.
- Participation in other clinical trials involving medication or medical devices within 3 months prior to screening.
- Any other condition deemed unsuitable for participation by investigators.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Mental Health Center
Shanghai, China
Actively Recruiting
Research Team
Z
Zhen Wang, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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