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Brain Mechanism and Intervention of Executive-control Dysfunction Among Gambling Disorder

Brain Mechanism and Intervention of Executive-control Dysfunction Among Gambling Disorder

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06195995
Enrollment
20
Registered
2024-01-08
Start date
2024-01-15
Completion date
2025-12-31
Last updated
2024-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gambling, Transcutaneous Electric Nerve Stimulation

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.

Interventions

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.

Sponsors

Shanghai Mental Health Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The change of pathological gamblingbaseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the interventionPathological 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.
The change of gambling behaviorbaseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the interventionQuestions including monetary loss, time, frequency and interval of gambling will be answered by patients to quantify their gambling behavior.
The change of gambling cravingbaseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the interventionGambling 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.
The change of gambling symptombaseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the interventionGambling 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.

Secondary

MeasureTime frameDescription
The change of self-controlbaseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the interventionThe change of self-control will be measured by the stop-signal task and balloon analog risk-taking task.

Other

MeasureTime frameDescription
The change of depressionbaseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the interventionDepression 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.
The change of anxietybaseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the interventionAnxiety 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.
The change of sleepbaseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the interventionSleep 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.

Countries

China

Contacts

Primary ContactJiang Du, MD, PhD
dujiangdou@163.com+862164906315

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026