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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Cumulated uncontrolled alcohol use days
研究概览
简要总结
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.
详细描述
Total of 12 subjects from two centers ( Shanghai Mental Health Center and The Second Xiangya Hospital of Central South University ) who meet inclusion and don't meet exclusion criteria are recruited to undergo neurosurgical implantation of dual-target DBS in bilateral nucleus accumbens (NAcc) and anterior limb of internal capsule (ALIC) on Day 0. The DBS system will be turned on for stimulation and parameter adjustment will be conducted on day 10-14 after implantation. The efficacy and safety evaluation will be conducted in 9-32 weeks after implantation. The indicators on efficacy are heaving drinking rate, uncontrolled alcohol consumption days, maximum consecutive alcohol abstinent days. The indicators for safety are adverse events (AE) and device related AE, serious adverse events (SAE) and device related SAE, device deficiencies (DD) and device malfunction, physical examination and vital signs, laboratory examination, ECG, imaging examination, scale evaluation and early drop out ratio due to AE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 65 years old, no limit on sex.
- •Meet The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for alcohol use diagnosis with more than 4 positive items.
- •Course of alcohol use disorder ≥ 3 years.
- •Had at least 3 failed quit drinking experiences (de-addiction treatment under medical conditions, quit drinking by oneself, quit drinking each time ≥ 1 week)
- •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.
排除标准
- •Patients with other serious mental disorders (e.g. schizophrenia spectrum, depression disorder, biphasic or related disorder, etc. )
- •Patients who have other substance (other than tobacco) use disorders.
- •During screening period, answered 'yes' on question 4 or 5 in suicide intention term from Columbia-Suicide Severity Rating Scale, or had significant suicidal ideations in the past 3 months, or patients who are considered by researchers to have suicide or violence risks.
- •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 human chorionic gonadotropin (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.
结局指标
主要结局
Cumulated uncontrolled alcohol use days
时间窗: 9-32 weeks of stimulation
Total days of all uncontrolled alcohol use days throughout 24 weeks 1. Definition: more than 3 times consecutive alcohol use (random draw) ≥ 5 standard cups 2. 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 3. Cumulated uncontrolled alcohol use days: Total days of all uncontrolled alcohol use days throughout 24 weeks
Heavy drinking rate
时间窗: 9-32 weeks of stimulation
Calculation formula: 'major alcohol use' times / 56 (total observation times) \* 100%; 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.
Maximum consecutive alcohol abstinent days
时间窗: 9-32 weeks of stimulation
Constant alcohol suspension standard: Blow test negative and no alcohol use reported over past 3 days. Marked as maximum days of 'Constant alcohol suspension'
次要结局
- Sleep status(At 12, 20 and 32 weeks of stimulation)
- affect status(At 12, 20 and 32 weeks of stimulation)
- Alcohol use volume(9-32 weeks after stimulation)
- Cumulated alcohol abstinent days(9-32 weeks of stimulation.)
- Subjective alcohol craving(At 12, 20 and 32 weeks of stimulation)
- Alcohol withdrawal scores(At 12, 20 and 32 weeks of stimulation)
- Social functionings(At 12, 20 and 32 weeks of stimulation)
研究者
Wei Hao
Chief Physician
Second Xiangya Hospital of Central South University