tACS Intervention for Methamphetamine Addiction — tACS for MUD  

Methamphetamine-dependence Clinical Trial

Official title: tACS Intervention for Methamphetamine Addiction

Status Completed

Clinical Trial Summary

A growing body of evidence suggests a wide range of brain areas are critical for regulating cognitive control over decisions and involving in drug related cue processing. Previous studies have demonstrated that transcranial alternating current stimulation (tACS) over prefrontal cortex reduces craving for meth dependences. In this study, the investigators investigated whether a current level of 15mA with a patented frequency of 77.5Hz tACS intervention of prefrontal cortex cortices in methamphetamine addiction could reduce the subjective craving and improve the cognitive abilities.

Clinical Trial Description

The study will be conducted at the drug rehabilitation center in China. The whole procedure includes enrollment, pre-intervention evaluation, intervention (for 2 weeks, twice daily, 10 times a week, 20 times in total), post-intervention evaluation and one month follow up evaluation.

In enrollment session, participants are recruited according to inclusion criteria.

Sample size was calculated by GPower 3.1.9.4. As Hi-tACS has not been investigated in drug addiction, therefore, according to the previous study 'Transcranial alternating current stimulation for treating depression: a randomized controlled trial', the investigators choose the effect size as 1.2. After calculation, the sample size per group should be at least 20. A total of sample size should be 40. Considering the rate of drop-out during the treatment, the investigators set the sample size as 60 (30 per group).

In the pre-intervention evaluation, firstly, participants need complete a questionnaire to assess their demographic information, drug addiction history and drug abstinence. And then are assigned to either active group or sham group according to the counterbalance of their basic demographic and drug use information. Then, participants need complete craving, cognitive ability and electroencephalogram (EEG) assessment. For craving assessing, participants are shown a video of methamphetamine usage for 5 minutes, and then rated on the visual analogue scale (0 means completely undesired and 100 means extremely wanting) to report their craving for methamphetamine. For cognitive ability and EEG signal assessing, the whole process is conducted on the computer according to instructions.

In the intervention session, tACS stimulates the scalp with three Nexalin electrodes (Nexalin Technology, Inc., Houston, TX, USA): the locations of electrodes are determined according to international 10/20 system for EEG recording, and a 4.45 × 9.53cm electrode is placed above the forehead (Fpz, Fp1, and Fp2), the other two 3.18 × 3.81cm electrodes are placed above both mastoid areas. The active group received 77.5 Hz tACS for 40 minutes per session. The sham group received treatment with identical technical parameters, which induced scalp sensations but without penetration of the electric field into the brain.

Post-intervention evaluation and one month follow up evaluation are the same as in pre-intervention evaluation.

To ensure study quality, some measures are taken as bellow: Researchers and drug rehabilitation staff will work together in whole process and the data will be converted into electronic versions once finishing each evaluation.

In the intervention, patients, operators, and raters were blind to treatment condition. Each patient is assigned a tACS device (real or sham) and raters are not present while treatments are administered.

After each treatment times, any side effect from participant's report are recorded to assure the safety and feasibility.

Statistical analyses will be performed using R Studio and Matlab. The principal statistical analysis will be performed using the linear mixed effect model. For details, piecewise linear mixed effect models will be conducted according to the changes patterns of scores (craving, BIS, BDI, BAI, PSQI) over time. The interaction term will be included in the linear mixed effect models to describe the changing rate (slope) difference between treatment groups. Pairwise comparison for craving/BIS/BAI/BDI/PSQI reduction speed before and after the treatment period, and the comparisons of follow-up after treatment to baseline across treatment groups, will be evaluated through the piecewise linear mixed effect models. Linear models will be employed, after confirming the normality of score changes.

The Person's correlation and Spearman's correlation will be conducted to estimate the corraltion between symptoms and score changes. In addition, significant results identified will be checked for consistency and robustness.

All missing data will be recorded and marked. ;

Related Conditions & MeSH terms

• Behavior, Addictive
• Methamphetamine-dependence

• NCT number: NCT06288997
• Study type: Interventional
• Source: Shanghai Mental Health Center
• Status: Completed
• Phase: N/A
• Start date: November 21, 2021
• Completion date: November 9, 2023