A Combined Neurofeedback- TMS Intervention for Alcohol Use Disorder - Aim 2
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in sociomoral attention switching
研究概览
简要总结
The purpose of this study is to help understand how attention processes influence brain engagement during emotion and social cognition. The investigators also want to know if these processes are associated with drinking alcohol.
Participation includes three study visits of about 2 hours each over approximately a month. The first visit involves a magnetic resonance imaging (MRI) scan and answering survey questions. Each of the next two visits will involve a session of transcranial magnetic stimulation (TMS, a non-invasive brain stimulation technique) followed by another MRI scan.
People in the Auburn/Opelika area 19 or older are eligible to participate. People who drink alcohol and people who do not drink or don't drink very much are invited to participate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1. Age 18 or Older
- •2A. (Drinker Group): Reports consuming 4 [if female]/ 5 [if male] or more standard drinks on one occasion at least 2 times a month AND/OR reports consuming more than 7 [if female]/ 14 [if male] standard drinks per week on average
- •2B. (Healthy Volunteer Group): Reports consuming 4 [if female]/ 5 [if male] or more standard drinks on one occasion less than once a month AND reports consuming less than 7 [if female]/ 14 [if male] standard drinks per week on average
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 sociomoral attention switching
时间窗: Baseline, immediately following TMS A, immediately following TMS B
MRI Task- analysis of behavioral data
Change in cue reactivity
时间窗: Baseline, immediately following TMS A, immediately following TMS B
MRI Task- analysis of behavioral data
Change in attention switching
时间窗: Baseline, immediately following TMS A, immediately following TMS B
MRI Task- analysis of behavioral data
次要结局
- Change in brain activity during cue reactivity(Baseline, immediately following TMS A, immediately following TMS B)
- Change in brain activity attention switching(Baseline, immediately following TMS A, immediately following TMS B)
- Change in brain activity during sociomoral attention switching(Baseline, immediately following TMS A, immediately following TMS B)
研究者
Samantha Fede
Assistant Professor
Auburn University