Evaluation of Bilateral HF-rTMS Over DLPFC in add-on to Usual Treatment on Abstinence in Alcohol Use Disorder Patients With Executive Dysfunction After Withdrawal
试验速览
- 阶段
- 不适用
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Percentage of participants with continuous complete alcohol abstinence
研究概览
简要总结
High frequency repetitive transcranial magnetic stimulation (HF-rTMS) over dorsolateral prefrontal cortex (DLPFC) could correct defective executive functions over the hyperactive reward circuit through the meso-fronto-limbic connections. The restored cortical inhibitory control over compulsive alcohol use, could improve abstinence after withdrawal. The goal of this study is to evaluate the efficacy of HF-rTMS over DLPFC in AUD patients with executive dysfunction after withdrawal.
详细描述
PARTICIPANTS:
Participants with AUD (moderate to mild according to Alcohol Dependance Scale) with executive dysfunctions will be randomized.
DESIGN:
This study is a multicenter pilot double blind randomized controlled trial. After at least seven days of alcohol residential detoxification, executive dysfunctions's participants will be tested. 64 of them with executive dysfunctions will be randomized either in the active rTMS group or in the sham rTMS group. TMS will be performed during hospitalisation over 10 days. rTMS are proposed as an add on to the usual treatment.
INTERVENTION:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double Blind
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-75 years
- •Alcohol use disorder according to DSM 5, moderate to mild according to ADS
- •Residential stay for alcohol detoxofication
排除标准
- •Cognitive deficits defined by MoCA <25 (Montreal Cognitive Assessment) performed at least 7days after alcohol detoxification and after at least 12 hours after benzodiazepine cessation
- •History of cerebral stroke
- •DSM-5 substance use disorders other than nicotine and alcohol
- •Contraindication for rTMS :
- •Pregnancy
- •History of epilepsy or seizure
- •Cochlear implants
- •Cardiac pacemaker or intracardiac lines, or metal in the body
- •Clinical history of complicated withdrawal symptoms
- •History of severe head trauma followed by loss of consciousness
- •Actual major depressive episode, schizophrenia according to the MINI (Mini International Neuropsychiatric Interview)
- •Breastfeeding women
- •Actual or history of organic failure including cirrhosis
- •Absence of health insurance; or patient with AME
- •Legal protection (curatorship or tutorship)
- •Deprive of freedom or security measure
- •No adequate mastering of the French language or no ability to consent
- •Major socio-economic problem: homelessness
- •No written informed consent
- •Participation in another interventional study
- •Secondary inclusion criteria (before randomization):
- •Abnormal executive function defined as at least 3 impaired measurements among 19 measurements of 7 tests (Stroop test, Wisconsin test; Trail making test, verbal fluency, 6 elements, Brixton test, Dual task Baddeley test) from the Greffex battery. Each measure will be considered as impaired if it is below 1.65 SD. The procedure and the measurement are standardized. The neuropsychological evaluation will be performed at least seven days after alcohol detoxification and after at least 12 hours after benzodiazepine cessation.
结局指标
主要结局
Percentage of participants with continuous complete alcohol abstinence
时间窗: 1 month after the end of rTMS sessions
Percentage of patients with continuous complete abstinence up to one month after the end of the rTMS treatment. The abstinence will be assessed using the Alcohol-Time Line Follow Back tool (TLFB). The Alcohol TLFB is a descriptive questionnaire, using a calendar, participants will retrospectively record at M1 the number of days they drank over the 30 days following the end of the rTMS treatment. Continuous complete abstinence will be defined as no day with alcohol consumption over the 30 days.
次要结局
- Time until the first heavy drinking days (HDD)(3 months after the end of rTMS sessions)
- Number of heavy drinking days (HDD)(3 month after the end of rTMS sessions)
- Percentage of participants with alcohol continuous complete abstinence(3 months after the end of rTMS sessions)
- Alcohol dependence severity assessed by the Alcohol Dependence Scale (ADS)(3 months after the end of rTMS sessions)
- Alcohol due induced craving using a Visual Analogic Scale (VAS)(At 3 months after the end of rTMS sessions)
- Number of impaired measures on the Grefex batery (executive functions)(1 month after the end of rTMS sessions)
- Trail making test(1 month after the end of rTMS sessions)
- Brixton test(1 month after the end of rTMS sessions)
- Number of cumulative abstinence days(3 months after the end of rTMS sessions)
- Alcohol cue induced craving using a Visual Analogic Scale (VAS)(At 1 month after the end of rTMS sessions)
- Wisconsin Test(1 month after the end of rTMS sessions)
- Quality of life assessed by the Quality of life Scale (AQoLS)(At 3 months after the end of rTMS sessions)
- % rTMS stimulation performed with optimal stimulation parameters(At the end of rTMS treatment)
- Percentage of participants experiencing sides effect(3 months at the end of rTMS treatment)
- Time to relapse(3 months after the end of rTMS sessions)
- Stroop test(1 month after the end of rTMS sessions)
- 6 elements(1 month after the end of rTMS sessions)
- Dual task Baddeley test(1 month after the end of rTMS sessions)
- Alcohol cue induced craving using the Cue induced Obsessive Compulsive Drinking Scale (OCDS)(at 3 months after the end of rTMS sessions)
- Change in Alcohol cue induced craving using a Visual Analogic Scale (VAS)(From baseline to the last rTMS session after the end of rTMS sessions)
- Verbal fluency(1 month after the end of rTMS sessions)
- Percentage of rTMS sessions performed.(At the end of rTMS treatment)