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

Primary Purpose

Substance Dependence, Executive Function Disorder, Transcranial Alternating Current Stimulation

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transcranial alternating current stimulation-true stimulus
Transcranial alternating current stimulation-sham stimulus
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Dependence focused on measuring Substance dependence, Execution-control dysfunction, Synchronization, Transcranial alternating current stimulation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Shanghai Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Experimental

Sham Comparator

Experimental

Sham Comparator

Arm Label

Healthy control group

Intervention group of amphetamine addiction

Control group of amphetamine addiction

Intervention group of alcohol addiction

Control group of alcohol addiction

Arm Description

No intervention is conducted in the healthy control group.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The change of working memory
The change of working memory will be measured by the two-back task.
DA metabolic rate
DA metabolism was measured by Positron Emission Computed Tomography
The change of decision-making ability
The change of decision-making ability will be measured by the Balloon Analog Risk Task.

Full Information

First Posted
March 5, 2022
Last Updated
March 28, 2022
Sponsor
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT05312359
Brief Title
Brain Mechanism and Intervention of Executive-control Dysfunction Among Substance Dependents
Official Title
Brain Mechanism and Intervention of Executive-control Dysfunction Caused by Impaired Prefrontal-ventral Striatum Synchronization Among Substance Dependents
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Dependence, Executive Function Disorder, Transcranial Alternating Current Stimulation
Keywords
Substance dependence, Execution-control dysfunction, Synchronization, Transcranial alternating current stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy control group
Arm Type
No Intervention
Arm Description
No intervention is conducted in the healthy control group.
Arm Title
Intervention group of amphetamine addiction
Arm Type
Experimental
Arm 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.
Arm Title
Control group of amphetamine addiction
Arm Type
Sham Comparator
Arm 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.
Arm Title
Intervention group of alcohol addiction
Arm Type
Experimental
Arm 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.
Arm Title
Control group of alcohol addiction
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Transcranial alternating current stimulation-true stimulus
Intervention Description
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 Type
Device
Intervention Name(s)
Transcranial alternating current stimulation-sham stimulus
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change of inhibitory control ability
Description
The change of inhibitory control ability will be reflected by participants' performance in the Go/No Go task.
Time Frame
baseline, immediately after the intervention, one month after the intervention, three months after the intervention
Title
The change of theta(θ) phase synchronicity
Description
The change of θ phase synchronicity in the prefrontal - ventral striatum pathway in amphetamine addicts and alcohol addicts will be measured by EEG.
Time Frame
baseline, immediately after the intervention, one month after the intervention, three months after the intervention
Title
The change of theta-gamma phase amplitude coupling(θ-γ PAC)
Description
The change of θ-γ PAC in the prefrontal - ventral striatum pathway in amphetamine addicts and alcohol addicts will be measured by EEG.
Time Frame
baseline, immediately after the intervention, one month after the intervention, three months after the intervention
Secondary Outcome Measure Information:
Title
The change of working memory
Description
The change of working memory will be measured by the two-back task.
Time Frame
baseline, immediately after the intervention, one month after the intervention, three months after the intervention
Title
DA metabolic rate
Description
DA metabolism was measured by Positron Emission Computed Tomography
Time Frame
baseline
Title
The change of decision-making ability
Description
The change of decision-making ability will be measured by the Balloon Analog Risk Task.
Time Frame
baseline, immediately after the intervention, one month after the intervention, three months after the intervention
Other Pre-specified Outcome Measures:
Title
The The change of depression
Description
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.
Time Frame
baseline, immediately after the intervention, one month after the intervention, three months after the intervention
Title
The change of anxiety
Description
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.
Time Frame
baseline, immediately after the intervention, one month after the intervention, three months after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiang Du
Phone
021-64906315
Email
dujiangdou@163.com
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China

12. IPD Sharing Statement

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

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