High Intensity Alternating Current Stimulation as a Neuromodulation Therapy for Alcohol Use Disorder: A Pilot Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorShanghai Mental Health Center

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • HI-tACS

    Device

    A 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

18 Participants
are divided into 1 treatment group
Group A: HI-tACSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
2

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.

Time frame
Baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention

Secondary outcomes

1

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.

Time frame
Baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
2

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.

Time frame
Baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
3

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.

Time frame
Baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
4

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.

Time frame
Immediately after the intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: