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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06195995
Other study ID # JDu-012
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 15, 2024
Est. completion date December 31, 2025

Study information

Verified date December 2023
Source Shanghai Mental Health Center
Contact Jiang Du, MD, PhD
Phone +862164906315
Email dujiangdou@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms

  • Gambling
  • Transcutaneous Electric Nerve Stimulation

Intervention

Device:
Transcranial alternating current stimulation-true stimulus
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.

Locations

Country Name City State
China Shanghai Mental Health Center Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

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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