Brain Mechanism and Intervention of Executive-control Dysfunction Among Substance Dependents

Shanghai Mental Health Center

Status: Not yet enrolling

Conditions: Transcranial Alternating Current Stimulation; Substance Dependence; Executive Function Disorder

Treatments: Device: Transcranial alternating current stimulation-sham stimulus; Device: Transcranial alternating current stimulation-true stimulus

Study type: Interventional

Funder types: Other

Identifiers

NCT05312359

JDu-010

Details and patient eligibility

About

The investigators assume that tACS could improve amphetamine and alcohol dependent patients' executive-control function by adjusting the synchronization patterns and enhancing the functional connectivity of the prefrontal-ventral striatum pathway. A random controlled trial will be used to test the effect of θ-tACS treatment. Three months follow-up assessment will be conducted to test the changing of executive-control function and its mechanism.

Full description

Substance abuse has become a major social and public health problem in China, especially for amphetamine abuse and alcohol abuse. Executive-control dysfunction is the main symptom for substance dependents. 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 cognitive, and tACS could improve executive-control function by adjusting the abnormal synchronization. But it has not been verified among MA or alcohol patients. The investigators assume that tACS could improve MA and alcohol dependent patients' executive-control function by adjusting the synchronization patterns and enhancing the functional connectivity of the prefrontal-ventral striatum pathway. A random controlled trial will be used to test the effect of θ-tACS treatment. Three months follow-up assessment will be conducted to test the changing of executive-control function and its mechanism. This study will provide a practical and theoretical basis for developing a novel treatment for substance dependents.

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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 criteria for amphetamine-type substance addiction or alcohol addiction
• Have used amphetamine or alcohol 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 (IQ<70)
• Abuse or dependence of other psychoactive substances (except nicotine) in the last 5 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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210 participants in 5 patient groups

Healthy control group

No Intervention group

Description:

No intervention is conducted in the healthy control group.

Intervention group of amphetamine addiction

Experimental group

Description:

A 20-minute tACS intervention of real-stimulus is conducted twice a day for a total of 10 days in the intervention group of amphetamine addiction.

Treatment:

Device: Transcranial alternating current stimulation-true stimulus

Control group of amphetamine addiction

Sham Comparator group

Description:

A 20-minute tACS intervention of sham-stimulus is conducted twice a day for a total of 10 days in the control group of amphetamine addiction.

Treatment:

Device: Transcranial alternating current stimulation-sham stimulus

Intervention group of alcohol addiction

Experimental group

Description:

A 20-minute tACS intervention of real-stimulus is conducted twice a day for a total of 10 days in the intervention group of alcohol addiction.

Treatment:

Device: Transcranial alternating current stimulation-true stimulus

Control group of alcohol addiction

Sham Comparator group

Description:

A 20-minute tACS intervention of sham-stimulus is conducted twice a day for a total of 10 days in the control group of alcohol addiction.

Treatment:

Device: Transcranial alternating current stimulation-sham stimulus