Normal SubjectsNCT07071493
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)
A study testing tPBM Group, taVNS Group, Combined Treatment Group: Stimulation Program (5 Weeks) in people with Normal Subjects, run by Yonsei University at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 40 years
- Conditions the study is for
- Normal Subjects
- What is being tested?
- tPBM Group, taVNS Group, Combined Treatment Group: Stimulation Program (5 Weeks)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 15 Jan 2025to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- All sexes
- No healthy volunteers
- Adult
- 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.
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea2 sites
Severance Hospital
Seoul, 03722
Samsung Medical Center
Seoul, 06351
About this study
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
Read more
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
- Being tested
- tPBM Group, taVNS Group, Combined Treatment Group: Stimulation Program (5 Weeks)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tPBM Group, taVNS Group, Combined Treatment Group: Stimulation Program (5 Weeks)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Three Group Intervention Studies | Experimental | * 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. Receives: Device: tPBM Group, taVNS Group, Combined Treatment Group: Stimulation Program (5 Weeks) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alcohol Craving Measured by the Penn Alcohol Craving Scale (PACS)
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.
Measured: Administered at baseline (V1), five weeks (V2)
Secondary outcomes (15)
Change in EEG-Based Neurophysiological Markers
To evaluate changes in EEG signals (e.g., power spectral density, event-related potentials) before and after 5 weeks of intervention.
Measured: Administered at baseline (V1), five weeks (V2)
Change in Heart Rate Variability (HRV)
To assess autonomic nervous system changes through time-domain and frequency-domain HRV parameters.
Measured: Administered at baseline (V1), five weeks (V2)
Change in Alcohol Use Measured by Alcohol Use Disorders Identification Test (AUDIT)
The AUDIT is a 10-item questionnaire designed to assess alcohol consumption, drinking behaviors, and alcohol-related problems. Higher scores indicate more severe alcohol-related issues. A score of 8 or above suggests hazardous or harmful alcohol use. Score Range: 0-40
Measured: Administered at baseline (V1), five weeks (V2)
Change in Drinking Motives Measured by Drinking Motives Questionnaire-Revised (DMQ-R)
The DMQ-R is a drinking motives scale developed to measure adult drinking motives. This tool consists of four subscales: enhancement motives, coping motives, conformity motives, and social motives, with a total of 20 items. Each drinking motive is assessed with 5 items, totaling 20 items overall, and each item is rated on a 5-point scale from 1 "Not at all" to 5 "Very much so." Higher scores in each drinking motive subscale indicate a stronger motivation for that particular type of drinking.
Measured: Administered at baseline (V1), five weeks (V2)
Change in Depressive Symptoms Measured by Beck Depression Inventory (BDI).
The Beck Depression Inventory (BDI) is a self-report questionnaire developed based on clinical symptoms of depression to assess the severity of depressive symptoms across 21 areas, including emotional, cognitive, and motivational aspects. Each item is rated on a 4-point scale (0 to 3), with total scores ranging from 0 to 63. A total score of 0-9 indicates no depression, 10-23 indicates moderate depression, and a score of 24 or above indicates severe depression.
Measured: Administered at baseline (V1), five weeks (V2)
Change in Anxiety Symptoms Measured by Beck Anxiety Inventory (BAI).
The Beck Anxiety Inventory (BAI) is a tool designed to measure the severity of anxiety, encompassing cognitive, emotional, and physical aspects of anxiety. It consists of 21 items. The BAI was primarily developed to distinguish anxiety from depression. Each item is rated on a 4-point scale (0 to 3), with total scores ranging from 0 to 63. A total score of 21 or below indicates minimal anxiety, 22-26 indicates moderate anxiety, 27-31 indicates severe anxiety, and a score of 32 or above indicates extreme anxiety.
Measured: Administered at baseline (V1), five weeks (V2)
Change in Sleep Quality Measured by Pittsburgh Sleep Quality Index (PSQI).
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses subjective sleep quality over the past month. It evaluates sleep quality across seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
Measured: Administered at baseline (V1), five weeks (V2)
Change in Impulsivity Measured by Barratt Impulsiveness Scale (BIS).
The Korean version of the Barratt Impulsiveness Scale-11 (BIS-11) is one of the most widely used self-report questionnaires for measuring impulsivity. It consists of three subcomponents: cognitive impulsivity, motor impulsivity, and non-planning impulsivity. The scale includes 30 self-report items, including 11 reverse-scored items. Each item is rated on a 4-point Likert scale ranging from 1 ("Not at all true") to 4 ("Always true"). Scores are calculated by summing the items, taking into account the reverse-scored items. Higher total scores indicate greater impulsivity.
Measured: 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).
The SOCRATES was originally designed to assess motivation for change in problem drinkers. The Korean version (SOCRATES-K) was adapted to better reflect the Korean context and is used to assess motivation for change in individuals with alcohol dependence or abuse. It consists of 19 items, each rated on a 5-point Likert scale ranging from 1 ("Not at all true") to 5 ("Always true").
Measured: Administered at baseline (V1), five weeks (V2)
Change in Interoceptive Awareness Measured by Multidimensional Assessment of Interoceptive Awareness (MAIA).
The Korean version of the Multidimensional Assessment of Interoceptive Awareness (MAIA) is a self-report questionnaire that reflects recent approaches such as mindfulness and acceptance, focusing on how individuals relate to internal experiences, including bodily sensations. It consists of 32 items related to interoceptive awareness. Each item is rated on a 7-point Likert scale ranging from 0 ("Not at all true") to 6 ("Always true"). Higher total scores, calculated by summing item scores, indicate greater interoceptive awareness.
Measured: Administered at baseline (V1), five weeks (V2)
Change in Craving and Metacognitive Control Measured by Meta Cognitions Questionnaire (MCQ).
The Korean version of the Metacognitions Questionnaire consists of 30 items and assesses metacognitive beliefs across five domains: positive beliefs about worry, negative beliefs about the uncontrollability and danger of worry, cognitive confidence, need to control thoughts, and cognitive self-consciousness. Each item is rated on a 4-point Likert scale ranging from 0 ("Do not agree") to 3 ("Strongly agree").
Measured: Administered at baseline (V1), five weeks (V2)
Change in Credit Assignment Task (CAT)
Participants will choose between two options, with rewards delivered after variable and unpredictable temporal delays. This task assesses participants' learning strategy and ability to infer the causal relationship between actions and outcomes when feedback is delayed, probing their capacity for temporal credit assignment.
Measured: Administered at baseline (V1), five weeks (V2)
Change in Delay Discounting Task (DDT)
Participants will complete a computer-based binary choice task in which they repeatedly choose between smaller immediate rewards and larger delayed rewards. The task is designed to assess delay discounting - the degree to which individuals devalue rewards as a function of delay.
Measured: Administered at baseline (V1), five weeks (V2)
Change in Loss Aversion Task (LAT)
A binary choice procedure will be used to assess individual sensitivity to loss aversion, where participants choose between mixed gambles involving potential gains and losses versus a certain outcome. This task quantifies the relative weighting of losses compared to gains.
Measured: Administered at baseline (V1), five weeks (V2)
Change in Choice under Risk and Ambiguity Task (CRAT)
A binary choice procedure will be conducted in which, on certain trials, the probability of winning will be hidden in order to assess decision making under ambiguity, as compared to decision making under risk.
Measured: Administered at baseline (V1), five weeks (V2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start15 Jan 2025
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal SubjectsStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Young-Chul Jung, Professor, MD, PhD, Principal investigator, Department of Psychiatry, Yonsei University College of Medicine Severance Hospital, Yonsei University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071493
- Sponsor's protocol ID
- A-STEAM-2024-01
- Other IDs
- RS-2024-00420674
- Status last verified
- Jul 2025
- First submitted
- 25 Jun 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07071493
- Acronym / sponsor ID
- A-STEAM-2024-01
- Conditions
- Normal Subjects
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Three Group Intervention Studies | Experimental | 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. 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. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Three Group Intervention Studies |
Primary outcome
Change in Alcohol Craving Measured by the Penn Alcohol Craving Scale (PACS)
Time frame: 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.
15 secondary outcomes
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)
Change in Delay Discounting Task (DDT)
Time frame: Administered at baseline (V1), five weeks (V2)
Change in Loss Aversion Task (LAT)
Time frame: Administered at baseline (V1), five weeks (V2)
Change in Choice under Risk and Ambiguity Task (CRAT)
Time frame: Administered at baseline (V1), five weeks (V2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Young-Chul Jung, Professor, MD, PhD principal investigator
Department of Psychiatry, Yonsei University College of Medicine Severance Hospital, Yonsei University Health System
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tPBM Group, taVNS Group, Combined Treatment Group: Stimulation Program (5 Weeks) in people with Normal Subjects, run by Yonsei University at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Alcohol Craving Measured by the Penn Alcohol Craving Scale (PACS) (time frame: Administered at baseline (V1), five weeks (V2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.