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

NCT05312359 | Unknown

• 1 other identifier: JDu-010
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Substance Dependence; Executive Function Disorder; Transcranial Alternating Current Stimulation

Keywords

Substance dependence; Execution-control dysfunction; Synchronization; Transcranial alternating current stimulation

Outcome Measures

Primary Outcomes (3)

• The change of inhibitory control ability

  The change of inhibitory control ability will be reflected by participants' performance in the Go/No Go task.

  baseline, immediately after the intervention, one month after the intervention, three months after the intervention

• The change of theta(θ) phase synchronicity

  The change of θ phase synchronicity in the prefrontal - ventral striatum pathway in amphetamine addicts and alcohol addicts will be measured by EEG.

  baseline, immediately after the intervention, one month after the intervention, three months after the intervention

• The change of theta-gamma phase amplitude coupling(θ-γ PAC)

  The change of θ-γ PAC in the prefrontal - ventral striatum pathway in amphetamine addicts and alcohol addicts will be measured by EEG.

  baseline, immediately after the intervention, one month after the intervention, three months after the intervention

Secondary Outcomes (3)

• The change of working memory

  baseline, immediately after the intervention, one month after the intervention, three months after the intervention

• DA metabolic rate

  baseline

• The change of decision-making ability

  baseline, immediately after the intervention, one month after the intervention, three months after the intervention

Other Outcomes (2)

• The The change of depression

  baseline, immediately after the intervention, one month after the intervention, three months after the intervention

• The change of anxiety

  baseline, immediately after the intervention, one month after the intervention, three months after the intervention

Study Arms (5)

Healthy control group

NO INTERVENTION

No intervention is conducted in the healthy control group.

Intervention group of amphetamine addiction

EXPERIMENTAL

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.

Device: Transcranial alternating current stimulation-true stimulus

Control group of amphetamine addiction

SHAM COMPARATOR

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.

Device: Transcranial alternating current stimulation-sham stimulus

Intervention group of alcohol addiction

EXPERIMENTAL

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.

Device: Transcranial alternating current stimulation-true stimulus

Control group of alcohol addiction

SHAM COMPARATOR

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.

Device: Transcranial alternating current stimulation-sham stimulus

Interventions

Transcranial alternating current stimulation-true stimulus DEVICE

The adhesive electrodes were placed at F3 and F4 positions of the 64-bit EEG caps of the 10-20 system, corresponding to bilateral prefrontal lobes respectively. Before the intervention, the individual alpha frequency (IAF) of the subjects was measured according to the average peak value of α waves at dorsolateral prefrontal cortex in the closed state. Then an alternating current at θ frequency (θ = IAF - 5Hz) was applied to each subject based on its IAF value. The amplitude of stimulation was increased with a step of 20μA starting from 0. When the subjects had a slight prickling sensation or optical illusion, the stimulation current was decreased with a step of 20μA until the sensation disappeared. The current value at this time was used as the stimulation current of the subjects.

Intervention group of alcohol addiction; Intervention group of amphetamine addiction

Transcranial alternating current stimulation-sham stimulus DEVICE

The adhesive electrodes were placed at F3 and F4 positions of the 64-bit EEG caps of the 10-20 system, corresponding to bilateral prefrontal lobes respectively. The actual stimulation waveform was just implemented in the first 60 s (or more longer) and then faded out.

Control group of alcohol addiction; Control group of amphetamine addiction

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• 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 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

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 (IQ\<70)
• Abuse or dependence of other 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

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Jiang Du

CONTACT

021-64906315; dujiangdou@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2022
• First Posted: April 5, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2025
• Study Completion: December 31, 2025
• Last Updated: April 5, 2022

Record last verified: 2022-01

Locations

CN (1)