An interventional study of deep brain stimulation in Deep Brain Stimulation, sponsored by Shanghai Mental Health Center. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Shanghai Mental Health Center · Not applicable, Interventional, and Treatment
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).
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:
Study recruitment is currently ongoing.
635 studies on the registry are indexed under Obsessive-Compulsive Disorder; 166 are open to participants now.
This study's planned enrollment of 18 is below the median of 45 across 520 interventional studies indexed under Obsessive-Compulsive Disorder.
Browse Obsessive-Compulsive Disorder studies →Shanghai Mental Health Center is the lead sponsor of 272 studies on the registry; 91 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Treatment 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:
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:
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:
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:
Adult autism:
Exclusion Criteria:
From screening period to baseline, patients who has significant improvement in evaluation scores:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 12 weeks
the duration of abstinence in gambling disorder
within 24 weeks of stimulation, longest consecutive days without gambling
Time frame: 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.
Time frame: 12 weeks
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.
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
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: within 24 weeks
Reduce rate of PANSS score in schizophrenia
Reduce rate of PANSS score compared to baseline after 8/24 weeks of stimulation.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: within 24 weeks
duration of abstinence in gambling disorder
within 24 weeks of stimulation, total days of sustained quit gambling
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: within 24 weeks
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