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 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 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 completion of the 2-week intervention

Secondary outcomes

1

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.

Time frame
Baseline, immediately after completion of the 2-week intervention
2

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 completion of the 2-week intervention
3

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.

Time frame
Immediately after each of the 20 HI-tACS sessions during the 2-week intervention period
4

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.

Time frame
Baseline, immediately after completion of the 2-week intervention

Other outcomes

1

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.

Time frame
Baseline, immediately after completion of the 2-week intervention
2

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.

Time frame
Baseline, immediately after completion of the 2-week intervention

Sponsors and contacts

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