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

NCT06195995 | Unknown DMC

• 1 other identifier: JDu-012
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Transcutaneous Electric Nerve Stimulation; Gambling

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

• The change of self-control

  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 (3)

• The change 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

• The change 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

• The change of sleep

  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

Study Arms (1)

Intervention group for gambling addiction

EXPERIMENTAL

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.

Device: Transcranial alternating current stimulation-true stimulus

Interventions

Transcranial alternating current stimulation-true stimulus DEVICE

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.

Intervention group for gambling addiction

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Gambling

Condition Hierarchy (Ancestors)

Risk-Taking; Behavior; Disruptive, Impulse Control, and Conduct Disorders; Mental Disorders

Study Officials

• Jiang Du, M.D., Ph.D.

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiang Du, MD, PhD

CONTACT

+862164906315; dujiangdou@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2023
• First Posted: January 8, 2024
• Study Start: January 15, 2024
• Primary Completion: January 1, 2025
• Study Completion: December 31, 2025
• Last Updated: June 14, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)