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

NCT ID: NCT06195995

Last Updated: 2024-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-15

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Transcutaneous Electric Nerve Stimulation Gambling

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group for gambling addiction

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.

Group Type EXPERIMENTAL

Transcranial alternating current stimulation-true stimulus

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jiang Du, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mental Health Center

Locations

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Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiang Du, MD, PhD

Role: CONTACT

+862164906315

Facility Contacts

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Jiang Du, MD, PhD

Role: primary

+86 021 6490 6315

Other Identifiers

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JDu-012

Identifier Type: -

Identifier Source: org_study_id

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