Gambling Clinical Trial
Official title:
Brain Mechanism and Intervention of Executive-control Dysfunction Among Gambling Disorder
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 31, 2025 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Mental Health Center | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Mental Health Center |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The change of depression | Depression will be measured by the Patient Health Questionnaire-9(PHQ-9). The total score of PHQ-9 ranged from 0 to 27, in which higher scores mean a higher level of depression. | 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 | The change of anxiety | Anxiety will be measured by the questionnaire of Generalized Anxiety Disorder(GAD-7). The total score of GAD-7 ranged from 0 to 21, in which higher scores mean a higher level of anxiety. | 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 | The change of sleep | Sleep will be measured by the Pittsburgh Sleep Quality Index (PSQI) rated by both patients and observers. The total score of PSQI ranged from 0 to 21, in which higher scores mean a lower level of 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 | |
Primary | The change of gambling behavior | Questions including monetary loss, time, frequency and interval of gambling will be answered by patients to quantify their gambling behavior. | 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 | |
Primary | The change of gambling craving | Gambling craving will be measured by the gambling craving Visual Analog Scale (VAS). The total score of VAS ranged from 0 to 10, in which higher scores mean a higher level of 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 | |
Primary | The change of gambling symptom | Gambling symptom will be measured by the Gambling Symptom Assessment Scale (G-SAS). The total score of G-SAS ranged from 0 to 48, in which higher scores mean a higher level of gambling symptom. | 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 | |
Primary | The change of pathological gambling | Pathological gambling will be measured by the Yale-Brown Obsessive Compulsive Scale adapted for Pathological Gambling (PG-YBOCS). The total score of PG-YBOCS ranged from 0 to 40, in which higher scores mean a higher level of pathological gambling. | 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 | The change of self-control | The change of self-control will be measured by the stop-signal task and balloon analog risk-taking task. | 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 |
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