Efficacy and Safety of Dual-target DBS for Treatment-resistant Alcohol Use Disorder
Alcohol Use Disorder, Deep Brain Stimulation
About this trial
This is an interventional treatment trial for Alcohol Use Disorder
Eligibility Criteria
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.
Sites / Locations
- Second Xiangya Hospital of Central South UniversityRecruiting
- Shanghai Mental Health CenterRecruiting
Arms of the Study
Arm 1
Experimental
dual-target deep brain stimulation
This is a single arm, prospective, open label clinical study, participants who fit inclusion/exclusion standards, completed physical anti-addiction treatments and surgical implantation standard will start DBS system stimulation and adjust parameters after 10-14 days of implantation. Then after stimulation for 9-32 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 32 weeks ± 7 days of following, once every 2-3 months.