A Combined Neurofeedback-TMS Intervention for Alcohol Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change in Brain Activity during Alcohol Cue Presentation over Time
研究概览
简要总结
The goal of this clinical study is to test the effectiveness of a supplemental fMRI neurofeedback and/or TMS intervention in individuals seeking treatment for Alcohol Use Disorder.
After an initial visit, participants will come in once a week for four (4) weeks for an intervention session, which may or may not include TMS and MRI. Participants will be contacted for monthly follow-ups (remotely) for up to 12 months and will be asked to come in for two MRI follow-ups at 6 and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The PI will prospectively assign treatment groups with blind codes and so will not be blind to treatment type. Other staff, who are the individuals primarily working with the patients and who will be conducting follow-up interviews, will be blind to treatment type. It is not possible to blind the 5th condition (treatment as usual with a brief check-in).
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving treatment for Alcohol Use Disorder
排除标准
- •MRI Contraindications
- •Presence of metal in the body that would make having a 7T MRI unsafe (including facial tattoos)
- •Claustrophobia, such that individual would be unable to stay in the MRI for up to 1 hr
- •Hearing loss, including tinnitus, that might be made worse by MRI or TMS
- •TMS Contraindications
- •Has ever had a seizure, or has a family history of epilepsy
- •Taking medications or substances that lower the seizure threshold
- •Implanted devices that are in the head or rely on physiological signals
- •History of neurological disease, such as stroke or brain tumor
- •Head injury with loss of consciousness greater than 30 minutes
- •Actively withdrawing from alcohol
- •Family history of schizophrenia or presence of psychotic symptoms
结局指标
主要结局
Change in Brain Activity during Alcohol Cue Presentation over Time
时间窗: Assessed at weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
Measured via fMRI; standard alcohol cue reactivity
Change in Brain Activity during Simultaneous Sociomoral & Alcohol Cue Presentation over Time
时间窗: Assessed at weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
Measured via fMRI; alcohol-cued sociomoral processing
Change in Alcohol Use over Time
时间窗: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions, pre and post), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups)
Alcohol Timeline Followback (alc-TLFB)
Change in Community Functioning over Time
时间窗: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups)
Drinker Inventory of Consequences (DrInC)
Change in Alcohol Craving over Time
时间窗: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions, pre and post), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups)
Alcohol Craving Questionnaire (ACQ)
Change in Employment Status over Time
时间窗: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups)
self-reported employment status
Change in Aggression and Victimization over Time
时间窗: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57 (follow-ups)
Revised Conflict Tactics Scales (CTS-R)
Change in Antisocial Behavior over Time
时间窗: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57 (follow-ups)
number of self-reported contacts with the police, convictions, and other criminal behaviors
次要结局
- Change in Brain Gray Matter Structure over Time(Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups))
- Change in Resting State Functional Connectivity over Time(Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups))
- Change in Brain White Matter Structure over Time(Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups))
研究者
Samantha Fede
Assistant Professor
Auburn University