Trials / Unknown
UnknownNCT05312359
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 210 (estimated)
- Sponsor
- Shanghai Mental Health Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Transcranial alternating current stimulation-true 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. 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. |
| DEVICE | Transcranial 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. |
Timeline
- Start date
- 2022-06-01
- Primary completion
- 2025-06-01
- Completion
- 2025-12-31
- First posted
- 2022-04-05
- Last updated
- 2022-04-05
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05312359. Inclusion in this directory is not an endorsement.