tACS Treatment for Cognitive Impairments in Methamphetamine Addicts

Methamphetamine Abuse Clinical Trial

Official title:

tACS Treatment for Cognitive Impairments in Methamphetamine Addicts

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06292156
• Other study ID #: CASPsy7
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2023
• Est. completion date: August 2024

Study information

• Verified date: March 2024
• Source: Beijing HuiLongGuan Hospital
• Contact: Xiangyang Zhang, M.D.,Ph.D
• Phone: +86-10-62710644
• Email: zhangxy[@]psych.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Methamphetamine Abuse

Intervention

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

Locations

Country	Name	City	State
China	Xin Hua Drug Rehabilitation Center	Mianyang

Sponsors (1)

Lead Sponsor	Collaborator
Beijing HuiLongGuan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Microstate associated with cognitive function	Investigate the microstate associated with cognitive function of methamphetamine patients using microstate analysis	Baseline, week 3, week7
Primary	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
Primary	The effect of immune system on cognitive function	The investigators immune indicators related to cognitive function using bioassay.	Baseline, week 3, week7
Primary	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
Primary	Genetic mechanism of cognitive function	The investigators performed comprehensive genetic testing to explore the genetic mechanism of cognitive function.	Baseline, week 3, week7
Secondary	Reverse learning task	Reverse learning task was used to access the compulsive drug using behavior of methamphetamine patients.	Baseline, week 3, week7
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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