deep brain stimulation / Deep Brain Stimulation · Interventional Study

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

ClinicalTrials.gov · August 20, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registry record for a planned, uncontrolled, open-label study of deep brain stimulation in six treatment-refractory mental disorders. No results have been posted. The study is recruiting and describes primary outcomes to be measured over 12–24 weeks, but the record contains no efficacy or safety data.

What was studied

Interventional, Single Group, Open label, Treatment purpose. Deep Brain Stimulation; age from 18 Years; to 65 Years. Intervention: DBS intervention group. n = 18. 1 site: China.

Key findings

Safety

Effect sizes, safety events, statistical significance, and completion rates are not available.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a registry record for an ongoing, uncontrolled, open-label device study with no results yet posted; it describes planned enrollment and outcome measures only.

Study design

As stated by the source record.

MethodsPrimary outcome measures: change of Y-BOCS score compared to baseline after 12 weeks of stimulation (assessed at 12 weeks.); reduce rate of PANSS score compared to baseline after 12 weeks of stimulation (assessed at 12 weeks); change of Montgomery-Åsberg Depression Rating Scale (MADRS) score compared to baseline after 12 weeks of stimulation (assessed at 12 weeks); change of BMI compared to baseline after 12 weeks of stimulation (assessed at 12 weeks); the duration of abstinence in gambling disorder (assessed at within 24 weeks); change of AuBC score compared to baseline after 12 weeks of sti…

DesignInterventional, Single Group, Open label, Treatment purpose

PopulationDeep Brain Stimulation; age from 18 Years; to 65 Years

Sample size18

InterventionDBS intervention group

Setting1 site: China

Reported figures

Quoted from the source exactly as published.

Planned enrollment18

Primary outcome: Y-BOCS change from baseline12 weeks

Primary outcome: PANSS score reduction from baseline12 weeks

Primary outcome: MADRS score change from baseline12 weeks

Primary outcome: BMI change from baseline12 weeks

Primary outcome: duration of abstinence in gambling disorder24 weeks

Primary outcome: AuBC score change from baseline12 weeks

Caveats

No results are reported in this registry record; enrollment is ongoing.
Single-arm, open-label design without control group or blinding limits causal inference.
Small estimated sample (18 participants) distributed across six disparate diagnoses; underpowered for each condition.
Effect sizes, safety events, statistical significance, and completion rates are not available.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Single-arm, open-label, prospective design without control group or blinding.

Directness

moderate

Primary outcomes measure clinical scales directly relevant to stated conditions.

Consistency

insufficient

No results reported; consistency cannot be assessed.

Risk of bias

limited

Open-label, single-arm design with no control; vulnerable to bias; blinding absent.

Sample adequacy

limited

Estimated 18 participants across six distinct diagnostic conditions; severely underpowered.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06112067). This is a study registration, not published results. Lead sponsor: Shanghai Mental Health Center. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 18 participants (ESTIMATED). Conditions: Deep Brain Stimulation. Interventions: DEVICE: deep brain stimulation. Primary outcome measures: change of Y-BOCS score compared to baseline after 12 weeks of stimulation , 12 weeks.; reduce rate of PANSS score compared to baseline after 12 weeks of stimulation , 12 weeks; change of Montgomery-Åsberg Depression Rating Scale (MADRS) score compared to baseline after 12 weeks of stimulation , 12 weeks; change of BMI compared to baseline after 12 weeks of stimulation , 12 weeks; the duration of abstinence in gambling disorder , within 24 weeks; change of AuBC score compared to baseline after 12 weeks of stimulation , 12 weeks. 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).

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Shanghai Mental Health Centerdeep brain stimulationDeep Brain StimulationNCT06112067