Alpha Down EEG Neurofeedback for Alcohol Use Disorder: Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- Participant retention rate over 1 week
研究概览
简要总结
This pilot study is testing a short brain training program called neurofeedback in adults with alcohol use disorder. Participants will complete three sessions over about one week. The goal is to learn if this approach is easy to complete, well tolerated, and acceptable to participants. We will also explore whether it is associated with changes in alcohol cravings and drinking.
详细描述
Alcohol use disorder (AUD) is a common condition, and many individuals do not respond fully to existing treatments. Neurofeedback is a non-invasive method that uses real-time electroencephalography (EEG) signals to provide feedback, allowing individuals to learn to modulate their brain activity.
This pilot study will evaluate a brief EEG-based neurofeedback intervention in adults with AUD. Participants will complete three in-person sessions over approximately one week. During each session, EEG sensors are placed on the scalp to measure brain activity, and participants receive real-time feedback based on these signals.
The neurofeedback protocol targets downregulation of alpha-band activity (8-12 Hz). This approach differs from traditional alpha-theta neurofeedback and is intended to target patterns of brain activity related to attention, inhibitory control, and craving.
The primary aim is to assess feasibility, tolerability, and acceptability. Feasibility will be evaluated through recruitment, retention, and session completion. Tolerability will be assessed by monitoring adverse events, and acceptability will be assessed through participant-reported experience.
Exploratory outcomes will include changes in alcohol craving and alcohol use based on self-report measures. These analyses are exploratory and intended to inform future studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Adults ages 18-65 Meets DSM-5 criteria for current Alcohol Use Disorder Willing and able to provide informed consent Participants must report alcohol consumption within the past 30 days. Not requiring inpatient withdrawal management at the time of enrollment
排除标准
- •History of epilepsy or seizure disorder (excluding uncomplicated alcohol withdrawal seizures) Current psychosis, mania, or acute suicidality, or any psychiatric condition that would impair the ability to provide informed consent or safely participate Acute alcohol intoxication at the time of study visits (as determined by breathalyzer) Pregnancy or breastfeeding Implanted electronic medical devices or metal in the head (excluding dental work), if incompatible with EEG procedures Severe cognitive impairment interfering with informed consent or participation Any medical or psychiatric condition that, in the opinion of the investigators, would make participation unsafe or interfere with study procedures
结局指标
主要结局
Participant retention rate over 1 week
时间窗: one week
Proportion of participants who complete all study visits
Proportion of participants experiencing adverse events during neurofeedback sessions over 1 week
时间窗: One week
Number and severity of adverse events
Proportion of scheduled neurofeedback sessions completed over 1 week
时间窗: One week
Proportion of scheduled neurofeedback sessions completed
次要结局
- Change in alcohol craving (PACS total score) from baseline to Visit 3 (~1 week)(One week)
- Change in alcohol consumption measured by Timeline Follow-Back (TLFB) from baseline (Visit 1) to post-intervention (Visit 3, ~1 week)(One week)
研究者
Olga Terechin, MD
MD
Brigham and Women's Hospital