Alpha Down EEG Neurofeedback for Alcohol Use Disorder: Feasibility Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство EEG Neurofeedback
  Participants will receive a brief course of EEG-based neurofeedback consisting of three sessions over approximately one week. During each session, scalp electrodes are placed to record brain activity using electroencephalography (EEG). Real-time feedback is provided to guide participants in modulating their brain activity. The neurofeedback protocol targets downregulation of alpha-band activity (8-12 Hz). Training is delivered using a standardized protocol with real-time visual and/or auditory

Первичные конечные точки

• Participant retention rate over 1 week [Срок оценки: one week]
• Proportion of participants experiencing adverse events during neurofeedback sessions over 1 week [Срок оценки: One week]
• Proportion of scheduled neurofeedback sessions completed over 1 week [Срок оценки: One week]

Вторичные конечные точки (2)

• Change in alcohol craving (PACS total score) from baseline to Visit 3 (~1 week) [Срок оценки: One week]
• Change in alcohol consumption measured by Timeline Follow-Back (TLFB) from baseline (Visit 1) to post-intervention (Visit 3, ~1 week) [Срок оценки: One week]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Imperatori C, Della Marca G, Amoroso N, Maestoso G, Valenti EM, Massullo C, Carbone GA, Contardi A, Farina B. Alpha/Theta Neurofeedback Increases Mentalization and Default Mode Network Connectivity in a Non-Clinical Sample. Brain Topogr. 2017 Nov;30(6):822-831. doi: 10.1007/s10548-017-0593-8. Epub 2017 Sep 21. PMID 28936792
• Wan H, Chen B, Li X, Bu J. Effect of EEG neurofeedback therapy on addiction disorders: A systematic review and meta-analysis. Addiction. 2026 Feb;121(2):225-238. doi: 10.1111/add.70164. Epub 2025 Aug 12. PMID 40798852
• Affan RO, Huang S, Cruz SM, Holcomb LA, Nguyen E, Marinkovic K. High-intensity binge drinking is associated with alterations in spontaneous neural oscillations in young adults. Alcohol. 2018 Aug;70:51-60. doi: 10.1016/j.alcohol.2018.01.002. Epub 2018 Jan 8. PMID 29778070

Идентификаторы

NCT: NCT07746154 · 2026P000000

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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