About this trial
This study aims to explore the efficacy of high intensity transcranial alternating current stimulation on individuals with alcohol use disorders. Utilizing a one-arm pilot study design, participants will undergo transcranial alternating current stimulation.
Eligibility criteria
This trial does not accept 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.
The change of drinking behavior
Questions including monetary loss, time, frequency and interval of drinking will be answered by patients to quantify their gambling behavior.
Secondary outcomes
The change of drinking urge
Alcohol craving 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.
The change of abstinence symptom
Alcohol withdrawal symptoms will be evaluated using the Clinical Institute Withdrawal Assessment for Alcohol, revised version (CIWA-Ar). The total score of CIWA-Ar ranges from 0 to 67, where higher scores indicate more severe alcohol withdrawal symptoms.
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 the Treatment Emergent Symptom Scale (TESS). The scale evaluates the presence and severity of adverse reactions, with higher scores indicating more significant side effects.
Sponsors and contacts
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