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

NCT ID: NCT07227545

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Alcohol use disorder (AUD) is become a major social and public health problem in China. Craving for alcohol and compulsive drinking behavior are the main symptom of AUD. Previous studies have demonstrated the relationship between cognitive dysfunction and prefrontal-ventral striatum pathway. Studies have shown that abnormal phase synchronization and phase-amplitude coupling (PAC) induced the impairment of cognition, and High-Intensity transcranial Alternating Current Stimulation (HI-tACS) could improve executive-control function thus by adjusting the abnormal synchronization. However, it has not been verified among AUD patients. The investigators assume that tACS could improve AUD patients' executive-control function by adjusting the synchronization patterns and enhancing the functional connectivity of the prefrontal-ventral striatum pathway. This study intends to test the effect of HI-tACS treatment. Three-month follow-up assessment will be conducted to test the changing of the craving and alcohol use behavior. This study will provide a practical and theoretical basis for developing a novel treatment for AUD.

Conditions

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Alcohol Use Disorder (AUD)

Keywords

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High-Intensity Transcranial Alternating Current Stimulation, Alcohol Use Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HI-tACS

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.

Group Type EXPERIMENTAL

HI-tACS

Intervention Type 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.

Interventions

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HI-tACS

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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;
* Agree to participate in follow-up assessments;
* No contraindications for MRI scanning.

Exclusion Criteria

* 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;
* Psychiatric disorders per DSM-5 criteria (e.g., schizophrenia, schizoaffective disorder, intellectual disability, autism spectrum disorder, dementia, memory impairment, or other cognitive disorders).
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai Mental Health Center

Shanghai, , China

Site Status

Countries

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China

Central Contacts

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Jiang Du, MD, PhD.

Role: CONTACT

Phone: +8602164906315

Email: [email protected]

Facility Contacts

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Jiang Du, MD, PhD.

Role: primary

Other Identifiers

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JDu-016

Identifier Type: -

Identifier Source: org_study_id