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

Brain Mechanism and Intervention of Executive-control Dysfunction Caused by Impaired Prefrontal-ventral Striatum Synchronization Among Substance Dependents

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05312359
Enrollment
210
Registered
2022-04-05
Start date
2022-06-01
Completion date
2025-12-31
Last updated
2022-04-05

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

Conditions

Executive Function Disorder, Substance Dependence, Transcranial Alternating Current Stimulation

Keywords

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

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.

Detailed 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.

Interventions

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.

DEVICETranscranial alternating current stimulation-sham stimulus

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.

Sponsors

Shanghai Mental Health Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The change of theta-gamma phase amplitude coupling(θ-γ PAC)baseline, immediately after the intervention, one month after the intervention, three months after the interventionThe change of θ-γ PAC in the prefrontal - ventral striatum pathway in amphetamine addicts and alcohol addicts will be measured by EEG.
The change of theta(θ) phase synchronicitybaseline, immediately after the intervention, one month after the intervention, three months after the interventionThe change of θ phase synchronicity in the prefrontal - ventral striatum pathway in amphetamine addicts and alcohol addicts will be measured by EEG.
The change of inhibitory control abilitybaseline, immediately after the intervention, one month after the intervention, three months after the interventionThe change of inhibitory control ability will be reflected by participants' performance in the Go/No Go task.

Secondary

MeasureTime frameDescription
The change of decision-making abilitybaseline, immediately after the intervention, one month after the intervention, three months after the interventionThe change of decision-making ability will be measured by the Balloon Analog Risk Task.
The change of working memorybaseline, immediately after the intervention, one month after the intervention, three months after the interventionThe change of working memory will be measured by the two-back task.
DA metabolic ratebaselineDA metabolism was measured by Positron Emission Computed Tomography

Other

MeasureTime frameDescription
The The change of depressionbaseline, immediately after the intervention, one month 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, one month 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.

Countries

China

Contacts

Primary ContactJiang Du
dujiangdou@163.com021-64906315

Outcome results

None listed

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