Efficacy and Safety of Combo-stim Deep Brain Stimulation for Treatment-refractory Mental Disorders

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShanghai Mental Health Center

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

18 Participants
are divided into 1 treatment group

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