Deep Brain StimulationNCT06112067
Efficacy and Safety of Combo-stim Deep Brain Stimulation for Treatment-refractory Mental Disorders
A study testing deep brain stimulation in people with Deep Brain Stimulation, run by Shanghai Mental Health Center at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Deep Brain Stimulation
- What is being tested?
- deep brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- f)CGI-S ≥ 4 in screening period and baseline. g)GAF ≤ 60 in screening period and baseline. h)Patient and guardian agree to DBS implant and sign informed consent after fully understood research aims, contents, anticipated treatments and risks.
- Treatment refractory bipolar with depression:
- Aged 18~65 when signing informed consent, outpatient or inpatient, male or female.
- Fits DSM-5 bipolar I or bipolar II criteria, currently with depression episode.
- Course of disorder ≥ 2 years.
- Fits treatment refractory bipolar with depression criteria (treated with two different kinds of treatment below, enough dosage and enough course of treatment ≥ 8 weeks, and cannot acquire symptom cure for 8 consecutive weeks, either i or ii):
- i.Used at least two medications (alone) among Olanzapine (10-20mg/d) + Fluoxetine (20-60mg/d), Quetiapine (200-600mg/d), Lurasidone (40-160mg/d), Lamotrigine (200-400mg/d) ii.Used at least one medication above (alone), and used one of medication above with another medication among Lamotrigine (200-400mg/d), Valproate (1000-2000mg/d) and lithium salt (blood lithium reaches 0.8mmol/L).
- e)Upon medication treatment, electroconvulsive therapy ≥ 12 times, no effect or failed (such as intolerant).
- f)Fits severe symptom criteria: i.Depression episode ≥ 12 weeks in screening period. ii.MADRS score ≥ 26 in screening period and baseline. iii.GCI-BP score ≥ 4 in screening period and baseline. iv.YMRS score ≥ 12 in screening period and baseline. g)Patient and guardian agree to DBS implant and sign informed consent after fully understood research aims, contents, anticipated treatments and risks.
- Treatment refractory anorexia nervosa:
- Aged 18~65 when signing informed consent, outpatient or inpatient, male or female.
- Fits DSM-5 anorexia nervosa criteria, consider both restricting type and binge-eating/purging type.
- 10 ≤ BMI < 16 in screening period and baseline.
- Fits treatment refractory anorexia nervosa criteria (both i, ii, iii and iv):
- i.Course of disorder ≥ 5 years, severe and sustained anorexia nervosa. ii.With ≥ 3 times repeated inpatient history and bad treatment effect (can't complete treatment or immediate relapse after treatment).
- iii.Through systemic nutrient treatment, medication (SSRIs and/or anti-psychotics), psychotherapies (such as reinforced CBT, FBT treatment), no effect or intolerant.
- iv.Worsened instability of clinical treatment, refuse treatment or bad reaction to reinforced treatment, last for more than 1 year, with more than 2 times of involuntary food intake.
- e)Patient and guardian agree to DBS implant and sign informed consent after fully understood research aims, contents, anticipated treatments and risks.
- Gambling disorder:
- Aged 18~65 when signing informed consent, outpatient or inpatient, male or female.
- Course of disorder ≥ 2 years.
- Diagnosed as gambling disorder based on DSM-5, fits medium or severe diagnostic standard (≥ 6 terms)
- Received systemic treatment (such as medication and social mental intervention) but still has iterative thoughts of impulse or gambling behaviors.
- Patient and guardian agree to DBS implant and sign informed consent after fully understood research aims, contents, anticipated treatments and risks.
- Adult autism:
- Aged 18~65 when signing informed consent, outpatient or inpatient, male or female.
- Fits DSM-5 autism spectrum disorder diagnostic standard, and there's severe, life-threatening iterative behaviors, and independently evaluated by two psychiatric doctors.
- AuBC score ≥ 62 in screening period and baseline.
- CGI-S score ≥ 4 in screening period and baseline.
- Course of disorder ≥ 10 years, received systemic behavior intervention or training ( such as critical reaction training, cognitive behavior intervention, language expression training, demonstration method, natural environment training, patriarch training, social skill training, intervention based on story tales, etc. ) but failed, or intolerant.
- Patient and guardian agree to DBS implant and sign informed consent after fully understood research aims, contents, anticipated treatments and risks.
Who cannot join
- 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%
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- 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.
- Female in gestation, lactation, or blood HCG / urine gestation test positive. Or patients who can't take effective contraception actions during the trial. Or patients planning to birth or give birth after the trial begins for 3 months.
- Currently involved or involved in other medication or medical device clinical trials 3 months before the screening period.
- Other patients who are considered unfit by investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai
Zhen Wang, MD,PhD, 862164387259 ext. 73516, wangzhen@smhc.org.cn
Zhen Wang, MD,PhD
About this study
Official title: Efficacy and Safety of Combo-stim Deep Brain Stimulation for Treatment-refractory Mental Disorders: a Multi-center, Single Arm, Prospective, Open-label, Extendable Study
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).
Read the detailed description
Total of 18 subjects from Shanghai Mental Health Center who fit inclusion and don't fit exclusion criteria are recruited to undergo neurosurgical implantation of combo-stim DBS in bilateral nucleus accumbens (NAcc) and anterior limb of internal capsule (ALIC) on a certain date, the DBS system will be turned on for stimulation and parameters adjusted 7-14 days after implantation, treatment purposes are evaluated after system has been turned on for 8-24 weeks. Primary efficacy is evaluated by change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), Positive and Negative Syndrome (PANSS), Montgomery-Asberg Depression Rating Scale (MADRS), Body Mass Index (BMI), Autism Behavior Checklist (AuBC) score and longest consecutive days without gambling within one month. Safety is evaluated by adverse events (AE) and device-related adverse events (ADE), serious adverse events (SAE) and serious device-related events (SADE), device deficiencies (DD) and device malfunction, physical examination and vital signs, laboratory examination, electrocardiogram (ECG), imaging examination, scale evaluation and early drop out ratio due to AE.
Recruitment Progress Update (As of August 2026)
This ongoing study has completed a total of 16 screenings and enrolled 15 participants. Detailed recruitment and safety status by indication is presented below:
- Obsessive-Compulsive Disorder (OCD) A total of 5 participants were screened, 4 participants were enrolled, and 1 participant failed screening. All 4 enrolled participants have completed study discontinuation.
- Bipolar Disorder A total of 6 participants were screened and all 6 participants were successfully enrolled with no screening failure. Among the enrolled participants, 5 participants have discontinued from the study, and 1 serious adverse event (SAE) has been reported in this subgroup.
- Schizophrenia Spectrum Disorder A total of 3 participants were screened and enrolled, with no screening failure. Two participants have discontinued from the study.
- Autism Spectrum Disorder A total of 2 participants were screened and enrolled, with no screening failure. Both enrolled participants have completed study discontinuation.
Study recruitment is currently ongoing.
- Conditions
- Deep Brain Stimulation
- Being tested
- 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
- Medical subject headings
- Obsessive-Compulsive Disorder, Schizophrenia, Anorexia Nervosa, Gambling, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep brain stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 12 weeks
the duration of abstinence in gambling disorder
within 24 weeks of stimulation, longest consecutive days without gambling
Measured: 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.
Measured: 12 weeks
Secondary outcomes (41)
Treatment efficacy rate in OCD
the number of treatment-response patient/total patient*100% after 8/12/24 weeks of stimulation. The Y-BOCS score reduce rate ≥ 35% and Clinical Global Impression Scale (CGI-I) score being 1 or 2 means treatment response.
Measured: within 24 weeks
Change in Y-BOCS score compared to baseline after 8/24 weeks of stimulation. Change of Y-BOCS score in OCD
Change in Y-BOCS score compared to baseline after 8/24 weeks of stimulation. The Y-BOCS is a test to rate the severity of obsessive-compulsive symptoms. Total of 10 items, total score is 40, minimum score is 0 (no symptom) , maximum score is 40 (extreme).
Measured: within 24 weeks
Change of CGI-S score in OCD
Change in CGI-S score compared to baseline after 8/12/24 weeks of stimulation. The clinical global impression (CGI) rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders. It is composed of Severity of Illness (CGI-S) and Global Improvement (CGI-I). Item or total score is not available for both scales, minimum score 0 (no symptom), maximum score 7 (extreme).
Measured: within 24 weeks
Change of HAMD-17 score in OCD
Change in Hamilton Depression Scale (HAMD-17) score compared to baseline after 8/12/24 weeks of stimulation. This is a 17-item clinician-rated scale that is used to measure the severity of depression. Total score is 52, minimum socre is 0 (no symptom), maximum score is 52 (severe).
Measured: within 24 weeks
Change of HAMA score in OCD
Change in Hamilton Anxiety Scale (HAMA) score compared to baseline after 8/12/24 weeks of stimulation. This is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety.The scale consists of 14 items, total score is 56, minimum score 0 (no symptom), maximum score 52 (severe).
Measured: within 24 weeks
CGI-I score in OCD
CGI-I score after 8/12/24 weeks of stimulation. The clinical global impression (CGI) rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders. It is composed of Severity of Illness (CGI-S) and Global Improvement (CGI-I). In CGI-I, minimum score 1 (very much improved), maximum score 7 (extremely deteriorated).
Measured: within 24 weeks
Sheehan Disability Scale score in OCD
Change in Sheehan Disability Scale (SDS) score compared to baseline after 8/12/24 weeks of stimulation. The Sheehan Disability Scale (SDS) is a short, simple, and cost-effective measure of disability and functional impairment. Total of 5 items, no total score/maximum/minimum score available.
Measured: within 24 weeks
Treatment efficacy rate in schizophrenia
Treatment efficacy rate (PANSS score reduce rate ≥ 20% compared to baseline) after 8/12/24 weeks of stimulation. The Positive and Negative Syndrome Scale (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).
Measured: within 24 weeks
Reduce rate of PANSS score in schizophrenia
Reduce rate of PANSS score compared to baseline after 8/24 weeks of stimulation.
Measured: within 24 weeks
Reduce rate of PANSS positive symptoms
Reduce rate of PANSS positive symptoms compared to baseline after 8/12/24 weeks of stimulation.
Measured: within 24 weeks
Reduce rate of PANSS negative symptoms
Reduce rate of PANSS negative symptoms compared to baseline after 8/12/24 weeks of stimulation.
Measured: within 24 weeks
Change in Global Assessment of Function (GAF) score in schizophrenia
e)Change in Global Assessment of Function (GAF) score compared to baseline after 8/12/24 weeks of stimulation. The Global Assessment of Functioning (GAF) is a numeric scale used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of an individual. Total of 10 items, toal score 100, minimum score 1 (severely impaired), maximum score 100 (extremely high functioning).
Measured: within 24 weeks
Change of CGI-S score in schizophrenia
Change in CGI-Schizophrenia score compared to baseline after 8/12/24 weeks of stimulation. The clinical global impression-schizophrenia (CGI-S) scale is a valid, reliable instrument to evaluate severity and treatment response in schizophrenia. Total of 5 items, total score 35, minimum score 5, maximum score 35.
Measured: within 24 weeks
CGI-I score in schizophrenia
Change in CGI-I score compared to baseline after 8/12/24 weeks of stimulation. The clinical global impression (CGI) rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders. It is composed of Severity of Illness (CGI-S) and Global Improvement (CGI-I). In CGI-I, minimum score 1 (very much improved), maximum score 7 (extremely deteriorated).
Measured: within 24 weeks
Change of MADRS score in bipolar with depression
Change in MADRS score compared to baseline after 8/24 weeks of stimulation. The Montgomery-Åsberg Depression Rating Scale (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).
Measured: within 24 weeks
Treatment efficacy rate in bipolar with depression
Treatment efficacy rate (ratio of patients whose MADRS score reduce ≥ 50% compared to baseline) after 8/12/24 weeks of stimulation. The Montgomery-Åsberg Depression Rating Scale (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).
Measured: within 24 weeks
Symptom relieve rate in bipolar with depression
Symptom relieve rate (ratio of patients whose MADRS score ≤ 12) after 8/12/24 weeks of stimulation. The Montgomery-Åsberg Depression Rating Scale (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).
Measured: within 24 weeks
Change of HAMD-17 score in bipolar with depression
Change of HAMD-17 score compared to baseline after 8/12/24 weeks of stimulation. The Hamilton Depression Rating Scale (HAMD 17) is a 17-item clinician-rated scale that is used to measure the severity of depression. Total score is 52, minimum score is 0 (no symptom), maximum score is 52 (extreme).
Measured: within 24 weeks
Change of YMRS score in bipolar with depression
Change of Young Manic Rating Scale (YMRS) score compared to baseline after 8/12/24 weeks of stimulation. The Young Mania Rating Scale (YMRS) is an eleven-item multiple choice diagnostic questionnaire which psychiatrists use to measure the presence and severity of mania and associated symptoms. The scale has eleven items and is based on the patient's subjective report of his or her clinical condition, total score is 60, minimum score 0 (no symptom), maximum score 60 (extreme).
Measured: within 24 weeks
Change of CGI-BP-S score in bipolar with depression
Change of CGI-BP-S score compared to baseline after 8/12/24 weeks of stimulation. The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania. Total of 3 subscales, total score is 7 for each scale, minimum score 1, maximum score 7.
Measured: within 24 weeks
CGI-I score in bipolar with depression
CGI-I score after 8/12/24 weeks of stimulation. The clinical global impression (CGI) rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders. It is composed of Severity of Illness (CGI-S) and Global Improvement (CGI-I). In CGI-I, minimum score 1 (very much improved), maximum score 7 (extremely deteriorated).
Measured: within 24 weeks
Change of Pittsburgh Sleep Quality Index (PSQI) in bipolar with depression
Change of Pittsburgh Sleep Quality Index (PSQI) score compared to baseline after 8/12/24 weeks of stimulation. The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. Total of 19 items, total score 21, minimum score 0, maximum score 21.
Measured: within 24 weeks
Change of SDS in bipolar with depression
Change of SDS score compared to baseline after 8/12/24 weeks of stimulation. The Sheehan Disability Scale (SDS) is a short, simple, and cost-effective measure of disability and functional impairment. Total of 5 items, no total score/maximum/minimum score available.
Measured: within 24 weeks
Change of BMI in anorexia nervosa
Change of BMI compared to baseline after 8/24 weeks of stimulation. Weight and height will be combined to report BMI in kg/m^2.
Measured: within 24 weeks
Change of Eating Disorder Examination Questionnaire 6.0 in anorexia nervosa
Change of Eating Disorder Examination Questionnaire 6.0 (EDEQ-6.0) score compared to baseline after 8/12/24 weeks of stimulation. The Eating Disorder Examination Questionnaire 6.0 (EDE-Q 6.0) is one of the most broadly used self-report tools that assesses attitudes and behaviors associated with eating disorders (EDs). Total of 28 items, there's no total score or maximum/minimum score.
Measured: within 24 weeks
Change of CGI-S score in anorexia nervosa
Change of CGI-S score compared to baseline after 8/12/24 weeks of stimulation. The clinical global impression (CGI) rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders. It is composed of Severity of Illness (CGI-S) and Global Improvement (CGI-I). Item or total score is not available for both scales, minimum score 0 (no symptom), maximum score 7 (extreme).
Measured: within 24 weeks
Change of HAMD-17 score in anorexia nervosa
Change of HAMD-17 score compared to baseline after 8/12/24 weeks of stimulation. The Hamilton Depression Rating Scale (HAMD 17) is a 17-item clinician-rated scale that is used to measure the severity of depression. Total score is 52, minimum score is 0 (no symptom), maximum score is 52 (extreme).
Measured: within 24 weeks
Change of HAMA score in anorexia nervosa
Change of HAMA score compared to baseline after 8/12/24 weeks of stimulation. This is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety.The scale consists of 14 items, total score is 56, minimum score 0 (no symptom), maximum score 52 (severe).
Measured: within 24 weeks
Change of Y-BOCS score in anorexia nervosa
Change of Y-BOCS score compared to baseline after 8/12/24 weeks of stimulation. The Y-BOCS is a test to rate the severity of obsessive-compulsive symptoms. Total of 10 items, total score is 40, minimum score is 0 (no symptom) , maximum score is 40 (extreme).
Measured: within 24 weeks
Change of Barratt Impulsivity Scale-11 in anorexia nervosa
Change of Barratt Impulsivity Scale-11 (BIS-11) score compared to baseline after 8/12/24 weeks of stimulation. The Barratt Impulsiveness Scale (BIS) is a widely used measure of impulsiveness. Total of 26 items, there's no total score or maximum/minimum score.
Measured: within 24 weeks
CGI-I score in anorexia nervosa
CGI-I score after 8/12/24 weeks of stimulation. The clinical global impression (CGI) rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders. It is composed of Severity of Illness (CGI-S) and Global Improvement (CGI-I). In CGI-I, minimum score 1 (very much improved), maximum score 7 (extremely deteriorated).
Measured: within 24 weeks
duration of abstinence in gambling disorder
within 24 weeks of stimulation, total days of sustained quit gambling
Measured: within 24 weeks
Subjective craving in gambling disorder
Change of Visual Analogue Scale (VAS) (0-10 scale, 0 is no craving, 10 is extreme craving) score compared to baseline after 8/12/24 weeks of stimulation.
Measured: within 24 weeks
Change of HAMD-17 in gambling disorder
Change in HAMD-17 score compared to baseline after 8/12/24 weeks of stimulation. The Hamilton Depression Rating Scale (HAMD 17) is a 17-item clinician-rated scale that is used to measure the severity of depression. Total score is 52, minimum score is 0 (no symptom), maximum score is 52 (extreme).
Measured: within 24 weeks
Change of HAMA in gambling disorder
Change in HAMA score compared to baseline after 8/12/24 weeks of stimulation. This is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety.The scale consists of 14 items, total score is 56, minimum score 0 (no symptom), maximum score 52 (severe).
Measured: within 24 weeks
Change of SDS in gambling disorder
Change in SDS score compared to baseline after 8/12/24 weeks of stimulation. The Sheehan Disability Scale (SDS) is a short, simple, and cost-effective measure of disability and functional impairment. Total of 5 items, no total score/maximum/minimum score available.
Measured: within 24 weeks
Change of AuBC score in autism disorder
Change in AuBC score compared to baseline after 8/24 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.
Measured: within 12 weeks
Change of Aberrant Behavior Checklist (AbBC) scorein autism disorder
Change in Aberrant Behavior Checklist (AbBC) score compared to baseline after 8/12/24 weeks of stimulation. The Aberrant Behavior Checklist (AbBC) is a symptom checklist for assessing problem behaviors of children and adults with developmental disabilities. Total of 58 items, total score 174, minimum score 0, maximum score 174.
Measured: within 24 weeks
Change of GCI-S score in autism disorder
Change in GCI-S score compared to baseline after 8/12/24 weeks of stimulation. The clinical global impression (CGI) rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders. It is composed of Severity of Illness (CGI-S) and Global Improvement (CGI-I). Item or total score is not available for both scales, minimum score 0 (no symptom), maximum score 7 (extreme).
Measured: within 24 weeks
CGI-I score in autism disorder
CGI-I score after 8/12/24 weeks of stimulation. The clinical global impression (CGI) rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders. It is composed of Severity of Illness (CGI-S) and Global Improvement (CGI-I). In CGI-I, minimum score 1 (very much improved), maximum score 7 (extremely deteriorated).
Measured: within 24 weeks
Change of ADL score in autism disorder
Change in Activity of Daily Living Scale (ADL) score compared to baseline after 8/12/24 weeks of stimulation. Activities of daily living (ADL) is a scale used in healthcare to refer to people's daily self-care activities. Total of 14 items, total score 56, minimum score 14, maximum score 56.
Measured: within 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start16 Oct 2023
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Brain StimulationStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- SceneRay Corporation, Limited, Huashan Hospital, Shanghai 6th People's Hospital, Changhai Hospital
- Responsible party
- Principal investigator, Zhen Wang, Shanghai Mental Health Center
- Investigators
- Zhen Wang, MD,PhD, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112067
- Sponsor's protocol ID
- DBS-TRP-01
- Status last verified
- Aug 2026
- First submitted
- 8 Oct 2023
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Combo-stim Deep Brain Stimulation for Treatment-refractory Mental Disorders: a Multi-center, Single Arm, Prospective, Open-label, Extendable Study
- ClinicalTrials.gov ID
- NCT06112067
- Acronym / sponsor ID
- DBS-TRP-01
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- SceneRay Corporation, Limited, Huashan Hospital, Shanghai 6th People's Hospital, Changhai Hospital
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Total of 18 subjects from Shanghai Mental Health Center who fit inclusion and don't fit exclusion criteria are recruited to undergo neurosurgical implantation of combo-stim DBS in bilateral nucleus accumbens (NAcc) and anterior limb of internal capsule (ALIC) on a certain date, the DBS system will be turned on for stimulation and parameters adjusted 7-14 days after implantation, treatment purposes are evaluated after system has been turned on for 8-24 weeks. Primary efficacy is evaluated by change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), Positive and Negative Syndrome (PANSS), Montgomery-Asberg Depression Rating Scale (MADRS), Body Mass Index (BMI), Autism Behavior Checklist (AuBC) score and longest consecutive days without gambling within one month. Safety is evaluated by adverse events (AE) and device-related adverse events (ADE), serious adverse events (SAE) and serious device-related events (SADE), device deficiencies (DD) and device malfunction, physical examination and vital signs, laboratory examination, electrocardiogram (ECG), imaging examination, scale evaluation and early drop out ratio due to AE.
Recruitment Progress Update (As of August 2026)
This ongoing study has completed a total of 16 screenings and enrolled 15 participants. Detailed recruitment and safety status by indication is presented below:
- Obsessive-Compulsive Disorder (OCD) A total of 5 participants were screened, 4 participants were enrolled, and 1 participant failed screening. All 4 enrolled participants have completed study discontinuation.
- Bipolar Disorder A total of 6 participants were screened and all 6 participants were successfully enrolled with no screening failure. Among the enrolled participants, 5 participants have discontinued from the study, and 1 serious adverse event (SAE) has been reported in this subgroup.
- Schizophrenia Spectrum Disorder A total of 3 participants were screened and enrolled, with no screening failure. Two participants have discontinued from the study.
- Autism Spectrum Disorder A total of 2 participants were screened and enrolled, with no screening failure. Both enrolled participants have completed study discontinuation.
Study recruitment is currently ongoing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DBS intervention group | Experimental | Device: deep brain stimulationThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (46 listed)
- Treatment refractory obsessive-compulsive disorder:
- 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:
Key exclusion criteria (18 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| deep brain stimulationDBS 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. | Device | DBS intervention group |
Primary outcome
change of Y-BOCS score compared to baseline after 12 weeks of stimulation
Time frame: 12 weeks.
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).
reduce rate of PANSS score compared to baseline after 12 weeks of stimulation
Time frame: 12 weeks
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).
change of Montgomery-Åsberg Depression Rating Scale (MADRS) score compared to baseline after 12 weeks of stimulation
Time frame: 12 weeks
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).
change of BMI compared to baseline after 12 weeks of stimulation
Time frame: 12 weeks
change of BMI compared to baseline after 12 weeks of stimulation. Weight and height will be combined to report BMI in kg/m^2.
the duration of abstinence in gambling disorder
Time frame: within 24 weeks
within 24 weeks of stimulation, longest consecutive days without gambling
change of AuBC score compared to baseline after 12 weeks of stimulation
Time frame: 12 weeks
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.
41 secondary outcomes
Treatment efficacy rate in OCD
Time frame: within 24 weeks
Change in Y-BOCS score compared to baseline after 8/24 weeks of stimulation. Change of Y-BOCS score in OCD
Time frame: within 24 weeks
Change of CGI-S score in OCD
Time frame: within 24 weeks
Change of HAMD-17 score in OCD
Time frame: within 24 weeks
Change of HAMA score in OCD
Time frame: within 24 weeks
CGI-I score in OCD
Time frame: within 24 weeks
Sheehan Disability Scale score in OCD
Time frame: within 24 weeks
Treatment efficacy rate in schizophrenia
Time frame: within 24 weeks
Reduce rate of PANSS score in schizophrenia
Time frame: within 24 weeks
Reduce rate of PANSS positive symptoms
Time frame: within 24 weeks
Reduce rate of PANSS negative symptoms
Time frame: within 24 weeks
Change in Global Assessment of Function (GAF) score in schizophrenia
Time frame: within 24 weeks
Change of CGI-S score in schizophrenia
Time frame: within 24 weeks
CGI-I score in schizophrenia
Time frame: within 24 weeks
Change of MADRS score in bipolar with depression
Time frame: within 24 weeks
Treatment efficacy rate in bipolar with depression
Time frame: within 24 weeks
Symptom relieve rate in bipolar with depression
Time frame: within 24 weeks
Change of HAMD-17 score in bipolar with depression
Time frame: within 24 weeks
Change of YMRS score in bipolar with depression
Time frame: within 24 weeks
Change of CGI-BP-S score in bipolar with depression
Time frame: within 24 weeks
CGI-I score in bipolar with depression
Time frame: within 24 weeks
Change of Pittsburgh Sleep Quality Index (PSQI) in bipolar with depression
Time frame: within 24 weeks
Change of SDS in bipolar with depression
Time frame: within 24 weeks
Change of BMI in anorexia nervosa
Time frame: within 24 weeks
Change of Eating Disorder Examination Questionnaire 6.0 in anorexia nervosa
Time frame: within 24 weeks
Change of CGI-S score in anorexia nervosa
Time frame: within 24 weeks
Change of HAMD-17 score in anorexia nervosa
Time frame: within 24 weeks
Change of HAMA score in anorexia nervosa
Time frame: within 24 weeks
Change of Y-BOCS score in anorexia nervosa
Time frame: within 24 weeks
Change of Barratt Impulsivity Scale-11 in anorexia nervosa
Time frame: within 24 weeks
CGI-I score in anorexia nervosa
Time frame: within 24 weeks
duration of abstinence in gambling disorder
Time frame: within 24 weeks
Subjective craving in gambling disorder
Time frame: within 24 weeks
Change of HAMD-17 in gambling disorder
Time frame: within 24 weeks
Change of HAMA in gambling disorder
Time frame: within 24 weeks
Change of SDS in gambling disorder
Time frame: within 24 weeks
Change of AuBC score in autism disorder
Time frame: within 12 weeks
Change of Aberrant Behavior Checklist (AbBC) scorein autism disorder
Time frame: within 24 weeks
Change of GCI-S score in autism disorder
Time frame: within 24 weeks
CGI-I score in autism disorder
Time frame: within 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhen Wang, MD,PhD principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing deep brain stimulation in people with Deep Brain Stimulation, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 46 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhen Wang, MD,PhD (862164387250 ext. 73516, wangzhen@smhc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of Y-BOCS score compared to baseline after 12 weeks of stimulation (time frame: 12 weeks.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.