tACS Treatment for Cognitive Impairments in Methamphetamine Addicts

Beijing HuiLongGuan Hospital68 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Methamphetamine Abuse

Interventions

Theta treatment groupDEVICE

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

Sham control groupDEVICE

Sham stimulation lasted 30 s (15 s of ramp- up and 15 s of ramp-down).

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Xin Hua Drug Rehabilitation Center

Mianyang, China

Outcomes

Primary Outcomes

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.

Time frame: Baseline, week 3

ERP components associated with cognitive function

Investigate the ERP components associated with cognitive function of methamphetamine patients using event-related potential analysis

Time frame: Baseline, week 3

Condition stop signal task

Condition stop signal task was used to assess cognitive control function, including proactive control and reactive control.

Time frame: Baseline, week 3

Neural oscillations associated with cognitive function

Investigate the neural oscillations associated with cognitive function of methamphetamine patients using time-frequency analysis.

Time frame: Baseline, week 3

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

Time frame: Baseline, week 3

Microstate associated with cognitive function

Investigate the microstate associated with cognitive function of methamphetamine patients using microstate analysis

Data from ClinicalTrials.gov

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Secondary Outcomes

Reverse learning task

Reverse learning task was used to access the compulsive drug using behavior of methamphetamine patients.

Time frame: Baseline, week 3

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.

Time frame: Baseline, week 3

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.

Time frame: Baseline, week 3

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.

Time frame: Baseline, week 3

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.

Time frame: Baseline, week 3

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

Time frame: Baseline, week 3

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.

Time frame: Baseline, week 3

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.

Time frame: Baseline, week 3

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.

Time frame: Baseline, week 3

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.

Time frame: Baseline, week 3

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.

Time frame: Baseline, week 3

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.

Time frame: Baseline, week 3

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.

Time frame: Baseline, week 3

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.

Time frame: Baseline, week 3

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.

Time frame: Baseline, week 3

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.

Time frame: Baseline, week 3