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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)

NCT07071493 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-07-17

No results posted yet for this study

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

Conditions

  • Normal Subjects

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.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • Young-Chul Jung, Professor, MD, PhD · Department of Psychiatry, Yonsei University College of Medicine Severance Hospital, Yonsei University Health System

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-15
Primary Completion
2025-08-31
Completion
2025-08-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07071493 on ClinicalTrials.gov