tACS Intervention for Methamphetamine Addiction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 5
- 主要终点
- Subjective craving
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Methamphetamine dependents
- •middle school degree or above
排除标准
- •Have contraindications to rTMS (head trauma, epilepsy or history of epilepsy, metal implant etc.)
- •psychiatric illnesses
- •intellectual impairment (IQ<90)
研究组 & 干预措施
Active tACS group
In the active group, the intervention is carried out using Hi-tACS with an intensive current of 15mA and a frequency of 77.5 Hz. Each intervention session lasts for 40 minutes, with two sessions conducted daily - one in the morning and one in the afternoon. The intervention is spread over a 10-day period, with sessions taking place five days per week, totaling two weeks.
干预措施: Active transcranial alternating current stimulation (Device)
Sham tACS group
The sham group undergoes sessions with the same technical settings, designed to produce similar scalp sensations but without effective penetration of the electric field into the brain. Each session lasts for 40 minutes, with two sessions conducted daily - one in the morning and one in the afternoon. The intervention is spread over a 10-day period, with sessions taking place five days per week, totaling two weeks.
干预措施: Sham transcranial alternating current stimulation (Device)
结局指标
主要结局
Subjective craving
时间窗: The day before intervention, the day after intervention, 2 weeks after intervention and 3 months after intervention.
Subjective craving is measured by using Analogue Scale (VAS) for craving after watching video stimulus, ranging from 0 to 100, where 0 indicates no craving at all and 100 represents an extremely intense craving.
Objective craving
时间窗: The day before intervention, the day after intervention, 2 weeks after intervention and 3 months after intervention.
Objective craving is measured by using the EEG recording to reflect the brain activity of individuals to the drug-related videos and pictures. EEG data were recorded when participants watch videos in Video-induced Craving Task (VCT) and when participants see pictures in Picture-induced Craving Task (PCT). The amplitude of late positive potential (LPP) was considered as a major outcome of the drug-cue related ERP, higher LPP is related to higher craving.
次要结局
- Resting-state brain activity(The day before intervention, the day after intervention, 2 weeks after intervention and 3 months after intervention.)
- Depression status(The day before intervention, the day after intervention, 2 weeks after intervention and 3 months after intervention.)
- Anxiety status(The day before intervention, the day after intervention, 2 weeks after intervention and 3 months after intervention.)
- Sleep status(The day before intervention, the day after intervention, 2 weeks after intervention and 3 months after intervention.)
- Impulsivity(The day before intervention, the day after intervention, 2 weeks after intervention and 3 months after intervention.)
- Uncertainty decision-making(The day before intervention, the day after intervention, 2 weeks after intervention and 3 months after intervention.)