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

Substance Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05312359
• Other study ID #: JDu-010
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2022
• Source: Shanghai Mental Health Center
• Contact: Jiang Du
• Phone: 021-64906315
• Email: dujiangdou[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 210
• Est. completion date: December 31, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Executive Function Disorder
• Substance Dependence
• Substance-Related Disorders
• Transcranial Alternating Current Stimulation

Intervention

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 a waves at dorsolateral prefrontal cortex in the closed state. Then an alternating current at ? frequency (? = 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.
• 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.

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The The change of depression	Depression 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.	baseline, immediately after the intervention, one month after the intervention, three months after the intervention
Other	The change of anxiety	Anxiety 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.	baseline, immediately after the intervention, one month after the intervention, three months after the intervention
Primary	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
Primary	The change of theta(?) phase synchronicity	The change of ? 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
Primary	The change of theta-gamma phase amplitude coupling(?-? PAC)	The change of ?-? 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	The change of working memory	The change of working memory will be measured by the two-back task.	baseline, immediately after the intervention, one month after the intervention, three months after the intervention
Secondary	DA metabolic rate	DA metabolism was measured by Positron Emission Computed Tomography	baseline
Secondary	The change of decision-making ability	The change of decision-making ability will be measured by the Balloon Analog Risk Task.	baseline, immediately after the intervention, one month after the intervention, three months after the intervention