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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: tPBM Group, taVNS Group, Combined Treatment Group: Stimulation Program (5 Weeks).
- Who it may be relevant to
- Registry conditions: Normal Subjects. Basic parameters: 19 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Interventions
- Device tPBM Group, taVNS Group, Combined Treatment Group: Stimulation Program (5 Weeks)
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.
Primary outcome measures
- Change in Alcohol Craving Measured by the Penn Alcohol Craving Scale (PACS) [Time frame: Administered at baseline (V1), five weeks (V2)]
Secondary outcome measures (12)
- Change in EEG-Based Neurophysiological Markers [Time frame: Administered at baseline (V1), five weeks (V2)]
- Change in Heart Rate Variability (HRV) [Time frame: Administered at baseline (V1), five weeks (V2)]
- Change in Alcohol Use Measured by Alcohol Use Disorders Identification Test (AUDIT) [Time frame: Administered at baseline (V1), five weeks (V2)]
- Change in Drinking Motives Measured by Drinking Motives Questionnaire-Revised (DMQ-R) [Time frame: Administered at baseline (V1), five weeks (V2)]
- Change in Depressive Symptoms Measured by Beck Depression Inventory (BDI). [Time frame: Administered at baseline (V1), five weeks (V2)]
- Change in Anxiety Symptoms Measured by Beck Anxiety Inventory (BAI). [Time frame: Administered at baseline (V1), five weeks (V2)]
- Change in Sleep Quality Measured by Pittsburgh Sleep Quality Index (PSQI). [Time frame: Administered at baseline (V1), five weeks (V2)]
- Change in Impulsivity Measured by Barratt Impulsiveness Scale (BIS). [Time frame: 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). [Time frame: Administered at baseline (V1), five weeks (V2)]
- Change in Interoceptive Awareness Measured by Multidimensional Assessment of Interoceptive Awareness (MAIA). [Time frame: Administered at baseline (V1), five weeks (V2)]
- Change in Craving and Metacognitive Control Measured by Meta Cognitions Questionnaire (MCQ). [Time frame: Administered at baseline (V1), five weeks (V2)]
- Change in Credit Assignment Task (CAT) [Time frame: Administered at baseline (V1), five weeks (V2)]
Eligibility criteria
1\) 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.
2\) Exclusion Criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
South Korea · 2 centers
- Severance Hospital — Seoul
- Samsung Medical Center — Seoul
Identifiers
NCT: NCT07071493 · A-STEAM-2024-01 · RS-2024-00420674