An Exploratory Preliminary Study on the Effect of Combined Transcranial Photobiomodulation(tPBM)-Transauricular Vagus Nerve Stimulation(taVNS) on Alcohol Craving and Neurophysiological Marker in Drinkers (in South Korea)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Change in Alcohol Craving Measured by the Penn Alcohol Craving Scale (PACS)
研究概览
简要总结
Study Summary This pilot study aims to explore the mechanisms and effects of non-invasive neurostimulation in individuals with alcohol use, in order to develop a more accessible and sustainable treatment approach for alcohol use disorder.
Objectives
To evaluate the impact of:
Transcranial photobiomodulation (tPBM) Transcutaneous auricular vagus nerve stimulation (taVNS) Combined tPBM + taVNS on alcohol craving and neurophysiological indicators.
Method Participants: 60 adults (30 at Severance Hospital, 30 at Samsung Medical Center) Design: Randomized into 3 groups (tPBM, taVNS, combined) Intervention: 15 minutes/day, 5 days/week for 5 weeks (home-based) Assessments: Questionnaires, neurocognitive tests, EEG, and heart rate variability (HRV) Safety: Weekly phone check-ins for monitoring adverse effects Follow-up: Post-intervention assessments after 5 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria
- •Adults aged between 19 and 40 years who are able to provide valid written informed consent.
- •Individuals who consume alcohol, have an AUDIT-K score of 4 or higher, and do not meet the DSM-5 criteria for alcohol use disorder.
- •Individuals who are capable of completing the 5-week stimulation program.
- •Individuals who voluntarily agree to participate and sign the informed consent form.
排除标准
- •Individuals who cannot read or understand the informed consent (e.g., illiterate individuals, non-Korean speakers).
- •Individuals with impaired decision-making capacity.
- •Pregnant women.
- •Vulnerable populations, including individuals employed by or under the supervision of the research institution, investigators, or sponsors (e.g., employees, students, military personnel).
- •Individuals unable to comply with the 5-week stimulation protocol.
- •Individuals diagnosed with alcohol use disorder according to DSM-5 criteria.
- •Individuals diagnosed with a substance use disorder other than alcohol or nicotine.
- •Individuals with metal allergies that may interfere with EEG or stimulation devices.
研究组 & 干预措施
Three Group Intervention Studies
* Stimulation Program (5 Weeks) Each participant will follow one of the following programs, assigned randomly, five days a week for a total duration of five weeks.
- tPBM Group: Participants will receive transcranial photobiomodulation (tPBM) for 15 minutes per day.
- taVNS Group: Participants will receive transcutaneous auricular vagus nerve stimulation (taVNS) for 15 minutes per day.
- Combined Treatment Group: Participants will simultaneously receive both tPBM and taVNS for 15 minutes per day.
干预措施: tPBM Group, taVNS Group, Combined Treatment Group: Stimulation Program (5 Weeks) (Device)
结局指标
主要结局
Change in Alcohol Craving Measured by the Penn Alcohol Craving Scale (PACS)
时间窗: Administered at baseline (V1), five weeks (V2)
The Pennsylvania Alcohol Craving Scale (PACS) consists of 5 items, each rated on a scale from 0 to 6. The scale comprehensively assesses the frequency, intensity, and duration of alcohol craving, as well as the individual's ability to resist drinking. The total score ranges from 0 to 30, with a score of 20 or higher indicating a level consistent with a substance use disorder. To evaluate changes in alcohol craving before and after a 5-week brain stimulation intervention using the Penn Alcohol Craving Scale (PACS). The study will compare the change in craving scores across three groups: combined stimulation (tPBM+taVNS), tPBM-only, and taVNS-only.
Change in Alcohol Craving Measured by the Penn Alcohol Craving Scale (PACS)
时间窗: Administered at baseline (V1), five weeks (V2)
The Pennsylvania Alcohol Craving Scale (PACS) consists of 5 items, each rated on a scale from 0 to 6. The scale comprehensively assesses the frequency, intensity, and duration of alcohol craving, as well as the individual's ability to resist drinking. The total score ranges from 0 to 30, with a score of 20 or higher indicating a level consistent with a substance use disorder. To evaluate changes in alcohol craving before and after a 5-week brain stimulation intervention using the Penn Alcohol Craving Scale (PACS). The study will compare the change in craving scores across three groups: combined stimulation (tPBM+taVNS), tPBM-only, and taVNS-only.
次要结局
- Change in EEG-Based Neurophysiological Markers(Administered at baseline (V1), five weeks (V2))
- Change in Heart Rate Variability (HRV)(Administered at baseline (V1), five weeks (V2))
- Change in Alcohol Use Measured by Alcohol Use Disorders Identification Test (AUDIT)(Administered at baseline (V1), five weeks (V2))
- Change in Drinking Motives Measured by Drinking Motives Questionnaire-Revised (DMQ-R)(Administered at baseline (V1), five weeks (V2))
- Change in Depressive Symptoms Measured by Beck Depression Inventory (BDI).(Administered at baseline (V1), five weeks (V2))
- Change in Anxiety Symptoms Measured by Beck Anxiety Inventory (BAI).(Administered at baseline (V1), five weeks (V2))
- Change in Sleep Quality Measured by Pittsburgh Sleep Quality Index (PSQI).(Administered at baseline (V1), five weeks (V2))
- Change in Impulsivity Measured by Barratt Impulsiveness Scale (BIS).(Administered at baseline (V1), five weeks (V2))
- Change in readiness to change measured by the Korean version of the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES-K).(Administered at baseline (V1), five weeks (V2))
- Change in Interoceptive Awareness Measured by Multidimensional Assessment of Interoceptive Awareness (MAIA).(Administered at baseline (V1), five weeks (V2))
- Change in Craving and Metacognitive Control Measured by Meta Cognitions Questionnaire (MCQ).(Administered at baseline (V1), five weeks (V2))
- Change in Credit Assignment Task (CAT)(Administered at baseline (V1), five weeks (V2))
- Change in Delay Discounting Task (DDT)(Administered at baseline (V1), five weeks (V2))
- Change in Loss Aversion Task (LAT)(Administered at baseline (V1), five weeks (V2))
- Change in Choice under Risk and Ambiguity Task (CRAT)(Administered at baseline (V1), five weeks (V2))
- Change in Anxiety Symptoms Measured by Beck Anxiety Inventory (BAI).(Administered at baseline (V1), five weeks (V2))
- Change in Sleep Quality Measured by Pittsburgh Sleep Quality Index (PSQI).(Administered at baseline (V1), five weeks (V2))
- Change in EEG-Based Neurophysiological Markers(Administered at baseline (V1), five weeks (V2))
- Change in Heart Rate Variability (HRV)(Administered at baseline (V1), five weeks (V2))
- Change in Alcohol Use Measured by Alcohol Use Disorders Identification Test (AUDIT)(Administered at baseline (V1), five weeks (V2))
- Change in Drinking Motives Measured by Drinking Motives Questionnaire-Revised (DMQ-R)(Administered at baseline (V1), five weeks (V2))
- Change in Depressive Symptoms Measured by Beck Depression Inventory (BDI).(Administered at baseline (V1), five weeks (V2))
- Change in Impulsivity Measured by Barratt Impulsiveness Scale (BIS).(Administered at baseline (V1), five weeks (V2))
- Change in readiness to change measured by the Korean version of the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES-K).(Administered at baseline (V1), five weeks (V2))
- Change in Interoceptive Awareness Measured by Multidimensional Assessment of Interoceptive Awareness (MAIA).(Administered at baseline (V1), five weeks (V2))
- Change in Craving and Metacognitive Control Measured by Meta Cognitions Questionnaire (MCQ).(Administered at baseline (V1), five weeks (V2))
- Change in Credit Assignment Task (CAT)(Administered at baseline (V1), five weeks (V2))
- Change in Delay Discounting Task (DDT)(Administered at baseline (V1), five weeks (V2))
- Change in Loss Aversion Task (LAT)(Administered at baseline (V1), five weeks (V2))
- Change in Choice under Risk and Ambiguity Task (CRAT)(Administered at baseline (V1), five weeks (V2))