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)

Yonsei University

Status: Invitation-only

Conditions: Normal Subjects

Treatments: Device: tPBM Group, taVNS Group, Combined Treatment Group: Stimulation Program (5 Weeks)

Study type: Interventional

Funder types: Other

Identifiers

NCT07071493

RS-2024-00420674 (Other Grant/Funding Number)

A-STEAM-2024-01

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 19 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Inclusion Criteria

1. Adults aged between 19 and 40 years who are able to provide valid written informed consent.
2. 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.
3. Individuals who are capable of completing the 5-week stimulation program.
4. Individuals who voluntarily agree to participate and sign the informed consent form.

2. Exclusion Criteria

1. Individuals who cannot read or understand the informed consent (e.g., illiterate individuals, non-Korean speakers).
2. Individuals with impaired decision-making capacity.
3. Pregnant women.
4. Vulnerable populations, including individuals employed by or under the supervision of the research institution, investigators, or sponsors (e.g., employees, students, military personnel).
5. Individuals unable to comply with the 5-week stimulation protocol.
6. Individuals diagnosed with alcohol use disorder according to DSM-5 criteria.
7. Individuals diagnosed with a substance use disorder other than alcohol or nicotine.
8. Individuals with metal allergies that may interfere with EEG or stimulation devices.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Three Group Intervention Studies

Experimental group

Description:

\* 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. 1. tPBM Group: Participants will receive transcranial photobiomodulation (tPBM) for 15 minutes per day. 2. taVNS Group: Participants will receive transcutaneous auricular vagus nerve stimulation (taVNS) for 15 minutes per day. 3. Combined Treatment Group: Participants will simultaneously receive both tPBM and taVNS for 15 minutes per day.

Treatment:

Device: tPBM Group, taVNS Group, Combined Treatment Group: Stimulation Program (5 Weeks)