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ENROLLING BY INVITATION
NCT07071493
NA

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)

Sponsor: Yonsei University

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

19 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-01-15

Completion Date

2025-08-31

Last Updated

2025-07-17

Healthy Volunteers

No

Conditions

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.

Locations (2)

Severance Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea