NCT06292156

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2023

Completed
27 days until next milestone

Study Start

First participant enrolled

December 30, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

December 3, 2023

Last Update Submit

December 15, 2025

Conditions

Keywords

Methamphetamine patientsCognitive impairmentstACS

Outcome Measures

Primary Outcomes (11)

  • 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

  • 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

  • Condition stop signal task

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

    Baseline, week 3

  • Neural oscillations associated with cognitive function

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

    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

    Baseline, week 3

  • Microstate associated with cognitive function

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

    Baseline, week 3

  • Neural Dynamic Coding of brain region associated with cognitive function

    Investigate the functional connection of brain region associated with cognitive function of methamphetamine patients using multivariate pattern analysis

    baseline, week 3

  • 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

  • The effect of immune system on cognitive function

    The investigators immune indicators related to cognitive function using bioassay.

    Baseline, week 3

  • The effect of brain derived neurotrophic factor(BDNF) on cognitive function

    The investigators BDNF indicators related to cognitive function using bioassay.

    Baseline, week 3

  • Genetic mechanism of cognitive function

    The investigators performed comprehensive genetic testing to explore the genetic mechanism of cognitive function.

    Baseline, week 3

Secondary Outcomes (16)

  • Reverse learning task

    Baseline, week 3

  • Beck Depression Scale

    Baseline, week 3

  • Barrett impulse Scale

    Baseline, week 3

  • Degree of insomnia

    Baseline, week 3

  • The Sensitivity to Punishment and Reward Questionnaire

    Baseline, week 3

  • +11 more secondary outcomes

Study Arms (2)

Theta treatment group

EXPERIMENTAL

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

Sham control group

SHAM COMPARATOR

In sham group, Sham stimulation lasted 30 s (15 s of ramp- up and 15 of ramp-down) .

Device: Sham control group

Interventions

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

Theta treatment group

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

Sham control group

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xin Hua Drug Rehabilitation Center

Mianyang, China

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 3, 2023

First Posted

March 4, 2024

Study Start

December 30, 2023

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Data will be avaliable on request

Locations