About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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%
Trial design
Treatments tested in this trial
- deep brain stimulation
Treatment groups
Sponsors and collaborators
Shanghai Mental Health Center
Lead sponsor
SceneRay Corporation, Limited
Collaborator
Huashan Hospital
Collaborator
Shanghai 6th People's Hospital
Collaborator
Changhai Hospital
Collaborator