Clinical trial NCT06195995: Brain Mechanism and Intervention of Executive-control Dysfunction Among Gambling Disorder
Official title: Brain Mechanism and Intervention of Executive-control Dysfunction Among Gambling Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transcutaneous Electric Nerve Stimulation
Gambling
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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 test the effect of tACS treatment. Three-month follow-up assessment will be conducted to test the changing of the executive-control function and its mechanism.

Detailed 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: The change of gambling behavior
timeFrame: 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
measure: The change of gambling craving
timeFrame: 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
measure: The change of gambling symptom
timeFrame: 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
measure: The change of pathological gambling
timeFrame: 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:
measure: The change of self-control
timeFrame: 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
Other outcomes:
measure: The change of depression
timeFrame: 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
measure: The change of anxiety
timeFrame: 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
measure: The change of sleep
timeFrame: 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
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Jiang Du, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: