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)

Обзор

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

Вмешательства

• Устройство 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.

Первичные конечные точки

• Change in Alcohol Craving Measured by the Penn Alcohol Craving Scale (PACS) [Срок оценки: Administered at baseline (V1), five weeks (V2)]

Вторичные конечные точки (12)

• Change in EEG-Based Neurophysiological Markers [Срок оценки: Administered at baseline (V1), five weeks (V2)]
• Change in Heart Rate Variability (HRV) [Срок оценки: Administered at baseline (V1), five weeks (V2)]
• Change in Alcohol Use Measured by Alcohol Use Disorders Identification Test (AUDIT) [Срок оценки: Administered at baseline (V1), five weeks (V2)]
• Change in Drinking Motives Measured by Drinking Motives Questionnaire-Revised (DMQ-R) [Срок оценки: Administered at baseline (V1), five weeks (V2)]
• Change in Depressive Symptoms Measured by Beck Depression Inventory (BDI). [Срок оценки: Administered at baseline (V1), five weeks (V2)]
• Change in Anxiety Symptoms Measured by Beck Anxiety Inventory (BAI). [Срок оценки: Administered at baseline (V1), five weeks (V2)]
• Change in Sleep Quality Measured by Pittsburgh Sleep Quality Index (PSQI). [Срок оценки: Administered at baseline (V1), five weeks (V2)]
• Change in Impulsivity Measured by Barratt Impulsiveness Scale (BIS). [Срок оценки: 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). [Срок оценки: Administered at baseline (V1), five weeks (V2)]
• Change in Interoceptive Awareness Measured by Multidimensional Assessment of Interoceptive Awareness (MAIA). [Срок оценки: Administered at baseline (V1), five weeks (V2)]
• Change in Craving and Metacognitive Control Measured by Meta Cognitions Questionnaire (MCQ). [Срок оценки: Administered at baseline (V1), five weeks (V2)]
• Change in Credit Assignment Task (CAT) [Срок оценки: Administered at baseline (V1), five weeks (V2)]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

South Korea · 2 центра

• Severance Hospital — Seoul
• Samsung Medical Center — Seoul

Идентификаторы

NCT: NCT07071493 · A-STEAM-2024-01 · RS-2024-00420674

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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