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

NCT06112067 | Recruiting

• 1 other identifier: DBS-TRP-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Deep Brain Stimulation

Keywords

deep brain stimulation; nucleus accumbens; anterior limb of internal capsule; obsessive-compulsive disorder; schizophrenia; bipolar with depression; anorexia nervosa; gambling disorder; adult autism

Outcome Measures

Primary Outcomes (6)

• 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).

  12 weeks.

• 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).

  12 weeks

• 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).

  12 weeks

• 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.

  12 weeks

• the duration of abstinence in gambling disorder

  within 24 weeks of stimulation, longest consecutive days without gambling

  within 24 weeks

• change of AuBC score compared to baseline after 12 weeks of stimulation

  change of Autism Behavior Checklist (AuBC) score compared to baseline after 12 weeks of stimulation. The Autism Behavior Checklist (AuBC) is a 57-item behavior rating scale assessing the behaviors and symptoms of autism for children 3 and older. Total score 228, minimum score 57, maximum score 228.

  12 weeks

Secondary Outcomes (41)

• Treatment efficacy rate in OCD

  within 24 weeks

• Change in Y-BOCS score compared to baseline after 8/24 weeks of stimulation. Change of Y-BOCS score in OCD

  within 24 weeks

• Change of CGI-S score in OCD

  within 24 weeks

• Change of HAMD-17 score in OCD

  within 24 weeks

• Change of HAMA score in OCD

  within 24 weeks

Study Arms (1)

DBS intervention group

EXPERIMENTAL

This is a single arm, prospective, open label clinical study, participants who fit inclusion standards, don't fit exclusion standards and fit surgical implantation standard will start DBS system stimulation and adjust parameters after 7-14 days of implantation. Then after stimulation for 8-24 weeks, they will be evaluated for treatment efficacies. This study is extendable, with agreements from participants, long term efficacy and safety follow-up study will be performed after 24 weeks ± 7 days, specific plan depends on different mental disorders.

Device: deep brain stimulation

Interventions

deep brain stimulation DEVICE

DBS 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.

DBS intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Treatment refractory obsessive-compulsive disorder:
• Aged 18\~65 when signing informed consent, outpatient or inpatient, male or female.
• Fits DSM-5 obsessive-compulsive disorder criteria.
• Fits treatment refractory obsessive-compulsive disorder criteria (both i and ii):
• i.Treated with at least 3 kinds of serotonin reuptake inhibitors (SSRIs) with at least 2 kinds of 2nd generation antipsychotic medication as enhancement, enough dosage and enough course of treatment, and still no effect or intolerant.
• ii.While using enough dosage of SSRIs, treated with more than 8\~12 times of Cognitive Behavior Therapy (CBT) or CBT-intolerant.
• d)Y-BOCS score ≥ 25 in screening period and baseline. e)CGI-S score ≥ 4 in screening period and baseline. f)Patient and guardian agree to DBS implant and sign informed consent after fully understood research aims, contents, anticipated treatments and risks.
• Treatment refractory schizophrenia:
• Aged 18\~65 when signing informed consent, outpatient or inpatient, male or female.
• Fits DSM-5 schizophrenia criteria.
• Course of disorder ≥ 5 years.
• Fits treatment refractory schizophrenia criteria, one of the conditions below:
• i.Treated with more than 2 different anti-psychotic medications (clozapine excluded), enough dosage (equivalent dosage as chlorpromazine ≥ 600mg/day), enough course of treatment (≥ 12 weeks), no effect or intolerant.
• ii.Treated with enough dosage of clozapine (≥ 300mg/day or blood medication concentration ≥ 350ng/ml, enough course of treatment (≥ 12 weeks), no effect or intolerant.
• e)PANSS score ≥ 70 in screening period and baseline, and at least 1 item from 5 items (P1, P2, P3, P5, P6) of PANSS positive symptom scale ≥ 4; or at least 3 items from PANSS negative symptom scale (N1\~N7) ≥ 4, or at least 2 items ≥ 5.

You may not qualify if:

• 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.
• From screening period to baseline, patients who has significant improvement in evaluation scores:
• Obsessive compulsive disorder: Y-BOCS score decreased (or improved) ≥ 20%
• Schizophrenia: PANSS score decreased (or improved) ≥ 20%
• Bipolar with depression: MADRS score decreased (or improved) ≥ 20%
• Anorexia nervosa: BMI improved ≥ 20%
• Gambling: through evaluation by investigators, online gambling behavior is significantly improved
• Adult autism: AuBC score decreased (or improved) ≥ 20%.
• With severe or unstable cardiovascular, inspiratory, liver, kidney, blood, endocrine, neural system or other system disorders.
• Has neural system disorders including physical brain disorders, brain trauma, treatment-refractory seizure etc.
• During screening period or baseline, abnormalities in patient's physical examination, laboratory examination, electrocardiogram examination, imaging examination have significant clinical meaning, and patients who are considered unfit by investigators.
• Implanted artificial cochlea, pacemaker, similar single-side or double-side products or experienced other physical surgeries within half a year that are considered to have effect on this trial by investigators.
• DBS implant surgery taboos present and is considered unfit by investigators.
• Diagnosed as HIV positive.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• SceneRay Corporation, Limited: collaborator
• Huashan Hospital: collaborator
• Shanghai 6th People's Hospital: collaborator
• Changhai Hospital: collaborator

Study Sites (1)

Shanghai Mental Health Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Schizophrenia; Anorexia Nervosa; Gambling; Autistic Disorder

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Feeding and Eating Disorders; Risk-Taking; Behavior; Disruptive, Impulse Control, and Conduct Disorders; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Zhen Wang, MD,PhD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhen Wang, MD,PhD

CONTACT

862164387250; wangzhen@smhc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 8, 2023
• First Posted: November 1, 2023
• Study Start: October 16, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

CN (1)