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

Shanghai Mental Health Center

Status: Not yet enrolling

Conditions: Gambling Disorder

Treatments: Device: HI-tACS; Device: Sham stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07228182

JDu-017

Details and patient eligibility

About

The investigators assume that transcranial Alternating Current Stimulation (tACS) could improve gambling disorder patients' executive-control function by adjusting the synchronization patterns and enhancing the functional connectivity of the prefrontal-ventral striatum pathway. This study intends to validate the effect of tACS treatment, which has been discovered in the previous pilot study. Three-month follow-up assessment will be conducted to test the changing of the executive-control function and its mechanism.

Full description

Gambling disorder is become a major social and public health problem in China. Executive-control dysfunction is the main symptom of behavioral addiction like gambling disorder. 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 transcranial Alternating Current Stimulation (tACS) could improve executive-control function by adjusting the abnormal synchronization. However, it has not been verified among gambling disorder patients. The investigators assume that tACS could improve gambling disorder 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 tACS treatment, which has been discovered in the previous pilot study. Three-month follow-up assessment will be conducted to test the changing of the executive-control function and its mechanism. This study will provide a practical and theoretical basis for developing a novel treatment for gambling disorder.

Enrollment: 60 estimated patients

Sex: Male

Ages: 16 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Intervention group for gambling addiction

Experimental group

Description:

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 addiction.

Treatment:

Device: HI-tACS

Sham stimulation

Sham Comparator group

Description:

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 addiction.

Treatment:

Device: Sham stimulation