Effect of High-Intensity Transcranial Alternating Current Stimulation on Gambling Disorder: A Randomized Controlled Trial

NCT07228182 | Recruiting DMC FDA Device

• 1 other identifier: JDu-017
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators assume that High-intensity transcranial Alternating Current Stimulation (HI-tACS) could improve gambling disorder patients' executive-control function by modulating abnormal neural activity, particularly gamma-band oscillations, which are closely associated with executive-control deficits. This study intends to validate the effect of HI-tACS treatment, which has been discovered in the previous pilot study. A three-month follow-up assessment will be conducted to test the changes in executive-control function and its underlying mechanism.

Conditions

Gambling Disorder

Keywords

High-Intensity Transcranial Alternating Current Stimulation, Gambling disorder.

Outcome Measures

Primary Outcomes (1)

• Change of the gambling symptoms

  Gambling symptom severity will be measured by the Pathological Gambling Yale-Brown Obsessive Compulsive Scale (PG-YBOCS). The total score of PG-YBOCS ranges from 0 to 40, in which higher scores indicate more severe pathological gambling symptoms.

  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 (10)

• Change of depressive symptoms

  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

• Change of anxiety symptoms

  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

• Change of the sleep quality

  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

• Change of the gambling craving

  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

• Side effect of the modulation

  Immediately after the intervention

Other Outcomes (2)

• Individualized Electric Field Simulation and Dose Estimation

  Baseline, immediately after the intervention.

• Change of the molecular-level neurochemistry

  Baseline, immediately after the intervention.

Study Arms (2)

Intervention group for gambling disorder

EXPERIMENTAL

A 40-minute transcranial alternating current stimulus intervention of real stimulus is conducted twice a day (at least 3 hours apart) for a total of 10 days in the intervention group of gambling disorder.

Device: HI-tACS

Sham stimulation

SHAM COMPARATOR

A 40-minute transcranial alternating current stimulus intervention of sham stimulus is conducted twice a day (at least 3 hours apart) for a total of 10 days in the intervention group of gambling disorder.

Device: Sham stimulation

Interventions

HI-tACS DEVICE

Three conductive electrodes are placed overhead. In the 10/20 international placement system, a 4.45 9.53 cm electrode is placed on the forehead corresponding to Fpz, Fp1 and Fp2. Two 3.18 3.81 cm electrodes are placed on the mastoid region of each side. The tACS stimulation waveform includes ramp-up and ramp-down periods of 180 and 12 s, respectively. The frequency of stimulation is 77.5Hz, and the current is 15mA.

Intervention group for gambling disorder

Sham stimulation DEVICE

Three conductive electrodes are placed overhead. In the 10/20 international placement system, a 4.45 9.53 cm electrode is placed on the forehead corresponding to Fpz, Fp1 and Fp2. Two 3.18 3.81 cm electrodes are placed on the mastoid region of each side. The appearance of the above-mentioned equipment is identical to that of the real stimulation group devices, but it only simulates the electrical sensation produced at the beginning and end of stimulation.

Sham stimulation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18-60, male or female, with 9 or more years of education, and able to complete questionnaire evaluation and behavioral tests;
• Meet DSM-5 (Diagnostic and Statistical Manual of mental disorders，DSM) diagnostic criteria for gambling disorder;
• Have gambled for at least one year (at least once a week);
• Normal vision and hearing, or within the normal range after correction;
• Agree to cooperate in the follow-up evaluation;
• No metal implantation in the head, no history of nerve problems or head injury, and no skin sensitivity.

You may not qualify if:

• Have severe cognitive impairment, such as a history of head trauma, -cerebrovascular disease, epilepsy, etc.;
• Have used drugs promoting cognitive function in the last 6 months;
• Have impaired intelligence (Intelligence Quotient\<70);
• Abuse or dependence of psychoactive substances (except nicotine) in the last 5 years.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Gambling

Condition Hierarchy (Ancestors)

Risk-Taking; Behavior; Disruptive, Impulse Control, and Conduct Disorders; Mental Disorders

Central Study Contacts

Jiang Du, MD, PhD.

CONTACT

+8602164906315; dujiangdou@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2025
• First Posted: November 14, 2025
• Study Start: June 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 28, 2026
• Last Updated: June 10, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)