Alcohol Use Disorder Clinical Trial
Official title:
Efficacy and Safety of Dual-target Deep Brain Stimulation for Treatment-resistant Alcohol Use Disorder: 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 dual-target deep brain stimulation for treatment-resistant alcohol use disorder.
Status | Recruiting |
Enrollment | 12 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - 18 to 65 years old, no limit on sex. - Qualifies DSM-5 definition of alcohol use diagnosis, at least more than 4 terms. - Course of alcohol use disorder = 3 years. - Tried to quit drinking (de-addiction treatment under medical conditions, quit drinking by oneself, quit drinking each time = 1 week) but failed = 3 times. - Patient and relatives agree to accept systemic treatment of this study and sign Informed Consent Form after study purpose, content, expected treatment and risk etc. are fully explained and understood. Exclusion Criteria: - Patients who qualify DSM-5 serious mental disorder diagnosis standard (e.g. Schizophrenia spectrum, depression disorder, biphasic or related disorder, etc. ) - Patients who have other substance (tobacco excluded) abuse. - During screening period, answered 'yes' on question 4 or 5 in suicide intention term from Columbia-Suicide Severity Rating Scale, or had significant suicide intentions in the past 3 months, or patients who are considered by researchers to have suicide or violence risks. 4. Patients who have serious or unstable cardiovascular, respiratory, liver, kidney, hematological, endocrine, nervous system or other systemic diseases. - Patients who have implanted cochlear, pacemaker, cardiac defibrillator, single-sided or double-sided products of the same category, or the investigator evaluates patients have done surgeries within 6 months that can affect this study. - HIV positive patients. - Woman at pregnant or lactation period, or childbearing age woman test positive for HCG/urine pregnancy check; or patients who can't take effective contraception measures during trial; or patients who plan to be/make pregnant 3 months after the trial starts. - Patients who are participating other pharmaceutical or medical device clinical trials or have participated one in the past 3 months. - Patients who are considered unsuitable by investigators. |
Country | Name | City | State |
---|---|---|---|
China | Second Xiangya Hospital of Central South University | Changsha | Hunan |
China | Shanghai Mental Health Center | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Mental Health Center | Central South University, Huashan Hospital, SceneRay Corporation, Limited, Shanghai 6th People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Brain electrophysiology study(electroencephalogram) | Electroencephalographic rhythms (theta and beta) were recorded. And theta/beta ratio was compared to before stimulation | Before stimulation and parameter optimization period(1-8 weeks after stimulation) | |
Other | Brain electrophysiology study(Local Field Potentials) | Electrical signal strength was compared to before stimulation | Before stimulation and parameter optimization period(1-8 weeks after stimulation) | |
Other | PET-CT | Before DBS implant, use Positron Emission Topography (PET) technology to study imaging of brain metabolism. Metabolism features include the amount of dopamine, gamma-aminobutyric acid, glutamate. Patients will be retested for PET after 6 months of implant. | Before DBS implant, after 6 months of implant. | |
Primary | Major alcohol use rate | Calculation formula: 'major alcohol use' times / 56 (total observation times) * 100% | 24 weeks | |
Primary | Cumulated uncontrolled alcohol use days | Definition: more than 3 times consecutive alcohol use (random draw) = 5 standard cups
One time uncontrolled alcohol use days: e.g. 3 times consecutive follow-up results = 5 standard cups, fourth time < 5 standard cups, then uncontrolled alcohol use days is 3 * 3 = 9 days Cumulated uncontrolled alcohol use days: Total days of all uncontrolled alcohol use days throughout 24 weeks |
24 weeks | |
Primary | Maximum consecutive alcohol suspension days | a) Marked as maximum days of 'Constant alcohol suspension' b) Note: i. Major alcohol use standard: Blow test positive and reported = 5 standard cups daily over the past 3 days. 1 standard cup = 10g of pure alcohol.
ii. Minor alcohol use standard: No matter blow test is positive or not, alcohol use is reported over past 3 days but less than 5 standard cups. iii. Constant alcohol suspension standard: Blow test negative and no alcohol use reported over past 3 days. |
24 weeks | |
Secondary | Alcohol use volume | 9-32 weeks after stimulation, change in monthly average alcohol use volume compared to baseline. (Record in every follow-up according to participants. Record alcohol type, amount and experience when drinking throughout 9-32 weeks after stimulation. Increased value implies worse result and reduce of alcohol use volume indicates improvement. | 24 weeks | |
Secondary | Cumulated alcohol suspension days | total value of 'Constant alcohol suspension' days after 9-32 weeks of stimulation. | 24 weeks | |
Secondary | Subjective alcohol urge | Change in alcohol urge Visual Analogue Score compared to baseline. ( 0 is no urge, 10 is extreme urge) | At 12, 20 and 32 weeks of stimulation | |
Secondary | Alcohol abstinence | Change in CIWA-Ar score compared to baseline. | At 12, 20 and 32 weeks of stimulation | |
Secondary | Sleep condition | Pittsburgh Sleep Quality Index score compared to baseline. | At 12, 20 and 32 weeks of stimulation | |
Secondary | Emotion condition | Hamilton Anxiety Scale-17 and Hamilton Depression Scale score compared to baseline. | At 12, 20 and 32 weeks of stimulation | |
Secondary | Social functions | SDSS score compared to baseline. | At 12, 20 and 32 weeks of stimulation |
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