About this trial
This one-arm pilot study aims to evaluate the preliminary clinical, behavioral, and neurophysiological effects of high-intensity transcranial alternating current stimulation (HI-tACS) in individuals with alcohol use disorder (AUD). Participants will receive HI-tACS and undergo clinical and neurophysiological assessments before and after the intervention.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Education level of junior high school or above, capable of completing questionnaires and behavioral tests;
Aged 18-60 years;
Meet DSM-5 diagnostic criteria for Alcohol Use Disorder;
No abnormal findings on physical examination;
Disqualifiers
Have impaired intelligence (Intelligence Quotient<70);
Prior tDCS or TMS treatment within the past 3 months;
Contraindications for TMS therapy (e.g., intracranial metal implants, history of traumatic brain injury, skull defects, cardiac pacemakers, cardiovascular diseases, or epilepsy);
Severe somatic diseases or major organ dysfunction;
Trial design
Single group
Treatments tested in this trial
HI-tACS
DeviceA 40-minute 15mA transcranial alternating current stimulus intervention with 77.5 Hz of real stimulus is conducted twice a day (at least 3 hours apart) for a total of 10 days in the intervention group of AUD.
Treatment groups
Trial outcomes
Primary outcomes
The change of alcohol craving
Alcohol craving will be measured by the alcohol craving Visual Analog Scale (VAS). The total score of VAS ranged from 0 to 10, in which higher scores mean a higher level of alcohol craving.
Secondary outcomes
The change of drinking urge
Alcohol urge will be assessed using the Alcohol Urge Questionnaire (AUQ). The total score of AUQ ranges from 8 to 56, with higher scores indicating stronger urges to consume alcohol.
Change of the compulsive drinking behavior
Compulsive drinking behavior will be measured by the short form of the Obsessive-Compulsive Drinking Scale (OCDS). The total score of OCDS ranges from 0 to 40, with higher scores reflecting greater obsessive-compulsive thoughts and behaviors related to alcohol use.
Side effects of the modulation
Side effects will be assessed using a standardized adverse reaction evaluation form. The presence and severity of stimulation-related adverse reactions will be recorded for each symptom.
Change of depressive symptoms.
Depressive symptoms will be measured using the 17-item Hamilton Depression Rating Scale (HAMD-17). The total score ranges from 0 to 52, with higher scores indicating more severe depressive symptoms.
Other outcomes
Individualized Electric Field Simulation
Structural magnetic resonance imaging (sMRI), including T1-weighted imaging and diffusion tensor imaging (DTI), will be used to construct individualized head models for simulation of the electric field distribution induced by HI-tACS. Individualized electric field characteristics will be estimated to characterize interindividual variability in stimulation exposure.
Change of the molecular-level neurochemistry
SPICE fast spectroscopic imaging will be used to assess neurochemical metabolites and their spatial distributions in the brain. Changes in multiple metabolite and neurotransmitter-related measures will be examined to characterize alterations in brain neurochemical profiles following HI-tACS.
Sponsors and contacts
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