Research on the Heart-Brain Coupling Mechanisms and Interventions for Emotional Inhibitory Control Deficits in Individuals With Alcohol Use Disorder

Summary

The goal of this clinical trial is to understand whether combining transcutaneous auricular vagus nerve stimulation (taVNS) with mindfulness training can improve emotional inhibitory control in adults with Alcohol Use Disorder (AUD). The study also aims to explore the brain-heart coupling mechanisms underlying these control deficits.

The main questions it aims to answer are:

Do individuals with AUD have abnormal brain-heart coupling associated with impaired emotional inhibitory control? Can taVNS combined with mindfulness training enhance emotional inhibitory control in individuals with AUD compared to sham stimulation? Researchers will compare a group receiving taVNS plus mindfulness training to a group receiving sham stimulation plus mindfulness training to see whether the active intervention improves behavioral performance and brain-heart coupling.

Participants will:

Complete an emotional Go/NoGo task while EEG and ECG data are recorded Receive 10 days of either real or sham taVNS combined with mindfulness training Complete questionnaires and cognitive assessments before and after the intervention

Conditions

• Alcohol Use Disorder (AUD)

Interventions

DEVICE

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Participants receive transcutaneous auricular vagus nerve stimulation (taVNS) via a non-invasive ear-clip device targeting the cymba conchae. The device delivers electrical pulses at 25 Hz frequency with a pulse width of 200 µs, for 30 minutes daily over 10 consecutive days. The stimulation intensity is individually adjusted to the participant's perceptual threshold. taVNS is paired with standardized mindfulness training in this arm.

DEVICE

Sham Stimulation

Participants in this group use the same device as in the active taVNS condition, but the stimulation is deactivated. The ear-clip device is placed identically on the cymba conchae, with no electrical current delivered. This sham procedure mimics the look and feel of taVNS but serves as a placebo control. Sham stimulation is combined with the same mindfulness training as the experimental group.

BEHAVIORAL

Mindfulness Training

Participants receive instructor-led mindfulness training conducted by a trained therapist. Each session lasts 30 minutes and focuses on breath awareness, body scanning, and non-judgmental awareness of internal experience. All participants (both taVNS and sham groups) receive this training daily for 10 consecutive days.

Sponsors & Collaborators

• Shanghai Mental Health Center

  lead OTHER

Principal Investigators

• Jiang Du, M.D · Shanghai Mental Health Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-15

Primary Completion

2024-08-31

Completion

2024-08-31

Countries

• China

Study Locations