tACS Treatment for Cognitive Impairments in Methamphetamine Addicts

1. To evaluate the cognitive function of methamphetamine Patients.
2. Investigate the pathological mechanism of methamphetamine patients from the aspects of EEG and biology;
3. The investigators investigated the effects of transcranial alternating current stimulation (tACS) on cognitive impairments in methamphetamine patients

Study Overview

• Status: Recruiting
• Conditions: Methamphetamine Abuse
• Intervention / Treatment: Device: Theta treatment group; Device: Alpha active control group; Device: Sham control group

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiangyang Zhang, M.D.,Ph.D; Phone Number: +86-10-62710644; Email: zhangxy@psych.ac.cn

Study Locations

• China
  • Mianyang, China
    • Recruiting
    • Xin Hua Drug Rehabilitation Center
    • Contact: China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Clinical diagnosis diagnosis of methamphetamine use disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
• None of participants had mixed use of other drugs
• None of participants had physical disability
• None of participants had acute physical or mental illness, hallucinations, acute withdrawal symptoms
• None of participants were receiving any medical treatment

Exclusion Criteria:

• Intracranial hypertension
• Cranial defects
• Tumors
• Serious physical illnesses (e.g., cardiovascular, liver, kidney, gastrointestinal disorders)
• Infectious diseases
• Immune system disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Theta treatment group; In active tACS, the target 'active' electrode was placed over the MFC and the second 'return' electrode was placed over the medial parietal cortex. 6 Hz stimulation was used and a alternating current of 2mA was applied for 30min each day(Monday-Friday) for 3 consecutive weeks.	Device: Theta treatment group; The target 'active' electrode was placed over the MFC and the second 'return' electrode was placed over the medial parietal cortex. 6 Hz stimulation was used and a alternating current of 2mA was applied for 30min each day(Monday-Friday) for 3consecutive weeks
Active Comparator: Alpha active control group; In active tACS, the target 'active' electrode was placed over the MFC and the second 'return' electrode was placed over the medial parietal cortex. 10 Hz stimulation was used and a alternating current of 2mA was applied for 30min each day(Monday-Friday) for 3 consecutive weeks.	Device: Alpha active control group; The target 'active' electrode was placed over the MFC and the second 'return' electrode was placed over the medial parietal cortex. 10 Hz stimulation was used and a alternating current of 2mA was applied for 30min each day(Monday-Friday) for 3 consecutive weeks
Sham Comparator: Sham control group; In sham group, Sham stimulation lasted 30 s (15 s of ramp- up and 15 of ramp-down) .	Device: Sham control group; Sham stimulation lasted 30 s (15 s of ramp- up and 15 s of ramp-down).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)	The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), which contains 12 subtests for calculating the index scores of delayed memory (including list recall, story recall, figure recall, and list recognition tests), attention (including digit span and coding tests), language (including picture naming and semantic fluency tests), visuospatial/constructional index (including figure copy and line orientation tasks), immediate memory (including list learning and story memory tasks), and global neuropsychological function.	Baseline, week 3, week7
ERP components associated with cognitive function	Investigate the ERP components associated with cognitive function of methamphetamine patients using event-related potential analysis	Baseline, week 3, week7
Condition stop signal task	Condition stop signal task was used to assess cognitive control function, including proactive control and reactive control.	Baseline, week 3, week7
Neural oscillations associated with cognitive function	Investigate the neural oscillations associated with cognitive function of methamphetamine patients using time-frequency analysis.	Baseline, week 3, week7
Functional connection of brain region associated with cognitive function	Investigate the functional connection of brain region associated with cognitive function of methamphetamine patients using functional connection analysis	Baseline, week 3, week7
Microstate associated with cognitive function	Investigate the microstate associated with cognitive function of methamphetamine patients using microstate analysis	Baseline, week 3, week7
The effect of oxidative stress system on cognitive function	The investigators examined markers of oxidative stress related to cognitive function using bioassay.	Baseline, week 3, week7
The effect of immune system on cognitive function	The investigators immune indicators related to cognitive function using bioassay.	Baseline, week 3, week7
The effect of brain derived neurotrophic factor(BDNF) on cognitive function	The investigators BDNF indicators related to cognitive function using bioassay.	Baseline, week 3, week7
Genetic mechanism of cognitive function	The investigators performed comprehensive genetic testing to explore the genetic mechanism of cognitive function.	Baseline, week 3, week7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reverse learning task	Reverse learning task was used to access the compulsive drug using behavior of methamphetamine patients.	Baseline, week 3, week7
Beck Depression Scale	Beck Depression Scale was used to access degree of depression.The total score varies between 0 and 30 points, with higher scores indicating higher levels of depression.	Baseline, week 3, week7
Barrett impulse Scale	The scale includes three dimensions: motor impulsivity, cognitive impulsivity and unplanned impulsivity. The total score varies between 30 and 150 points, with higher scores indicating higher levels of impulsivity. High scores on the three subscales indicated hyperactivity, inattention, and lack of planning, respectively.	Baseline, week 3, week7
Degree of insomnia	Insomnia Severity Index was used acess the patient's insomnia.The total score varies between 0 and 28 points, with higher scores indicating higher levels of insomnia.	Baseline, week 3, week7
The Sensitivity to Punishment and Reward Questionnaire	The Sensitivity to Punishment and Reward Questionnaire including penalty sensitivity factor and reward sensitivity factor. The total score varies between 0 and 31 points, with higher scores indicating higher sensitivity to penalty and reward.	Baseline, week 3, week7
Visual analog scale	Visual analog scale（VAS） was used to acess the craving of drug on a scale of 1 to 10.A higher score indicates a higher desire for the drug	Baseline, week 3, week7
The Desires for Drug Questionnaire	The Desires for Drug Questionnaire (DDQ) was used to access the craving of drug, which measures three factors, including desire and intention, negative reinforcement, and control. Higher scores of drug desire and negative reinforcement indicated higher drug craving, and higher scores of control indicated better drug craving control ability.The total score on the table is equal to the sum of the scores in the three dimensions, ranging from 3 to 21 points.	Baseline, week 3, week7
Obsessive compulsive drug use scale	The Obsessive Compulsive Drug Use Scale (OCDUS) also measures three factors: thoughts about methamphetamine and interference, desire and control, and resistance to thoughts and intention.The higher the total score, the higher the craving. The total score varies between 13 and 65 points, with higher scores indicating higher craving.	Baseline, week 3, week7
Obsessive-compulsive inventory	Obsessive-compulsive inventory was evaluated the subjects' obsessive-compulsive symptoms from 6 different dimensions, including washing, forcing thoughts, storing, sorting, checking, mixing.The total score varies between 0 and 72 points, with higher scores indicating more severe obsessive-compulsive symptoms.	Baseline, week 3, week7
Thought Control Ability Questionnaire	Thought Control Ability Questionnaire was used to measure the ability of an individual to control unwanted and intrusive thoughts. The total score varies between 25 and 125 points, with higher indicating scores the stronger the thought control ability.	Baseline, week 3, week7
Thought Suppression Questionnaire	Thought Suppression Questionnaire were used to access the thought control ability. The total score varies between 15 and 75 points, with higher indicating scores the stronger the thought suppression ability.	Baseline, week 3, week7
Rumination Questionnaire	Rumination Questionnaire was used to access ruminate behavior.A higher total score indicates a higher tendency to ruminate. The total score varies between 22 and 88 points, with higher scores indicating higher tendency to ruminate.	Baseline, week 3, week7
Anger Rumination Questionnaire	Anger Rumination Questionnaire was used to access anger ruminate behavior. The total score varies between 19 and 76 points, with higher scores indicating higher tendency to anger ruminate.	Baseline, week 3, week7
Beck Anxiety Scale	Beck Anxiety Scale was used to access degree of anxiety.The total score varies between 0 and 63 points, with higher scores indicating higher levels of anxiety.	Baseline, week 3, week7
Emotional Regulation Difficulty Scale	Emotional Regulation Difficulty Scale was used to access the emotional regulation ability of methamphetamine patients.The total score varies between 36 and 180 points, with higher scores indicating the more serious the difficulty in emotion regulation and the lower the level of emotion regulation ability.	Baseline, week 3, week7
Aggressive questionnair	Aggressive questionnaire was used to access aggressive behavior of methamphetamine patients. The total score varies between 30 and 150 points, with higher scores indicating the more aggressive behavior.	Baseline, week 3, week7

Collaborators and Investigators

• Sponsor: Beijing HuiLongGuan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: December 3, 2023
• First Submitted That Met QC Criteria: March 2, 2024
• First Posted (Estimated): March 4, 2024

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 2, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: tACS; Cognitive impairments; Methamphetamine patients
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: CASPsy7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be avaliable on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No