Repetitive dTMS 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
- 2
- 主要终点
- Changes of Cue-induced craving and ERP
研究概览
简要总结
A growing body of evidence suggests a wide range of brain areas including medial prefrontal cortex (mPFC), dorsolateral prefrontal cortex (DLPFC) and other subcortical regions, such as anterior cingulate cortex (ACC) are critical for regulating cognitive control over decisions and involving in drug related cue processing. Previous studies have demonstrated that transcranial magnetic stimulation (rTMS) over dorsolateral prefrontal cortex reduces craving for meth dependences. Specifically, the H7 coil induces a magnetic field can target mPFC and ACC. In this study, the investigators investigated whether repeated dTMS intervention of medial prefrontal and cingulate 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 3 weeks, 5 times a week, 15 times in total), post-intervention evaluation and one month follow up evaluation.
In enrollment session, participants are recruited according to inclusion criteria.
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 10Hz 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, dTMS was administered using a TMS stimulator (Magstim, U.K.) equipped with a unique H-shaped coil design. The H-coil version used in this study was the H7 (Brainsway, Jerusalem, Israel). When placed 4-5 cm anterior to the foot motor cortex and used at 100% of the leg resting motor threshold (RMT), the H7 coil stimulates the dorsal mPFC and ACC bilaterally. A participant's RMT was determined before the first treatment and at the beginning of each week by ascertaining the coil position that elicited the minimal involuntary contractions of the feet (three of six attempts). The 10Hz group received 10 Hz dTMS at 100% of RMT, with 3-second pulse and 17-second intervals, for a total of 50 trains and 1500 pulses 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.
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 60 Years（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)
结局指标
主要结局
Changes of Cue-induced craving and ERP
时间窗: the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention
Subjective craving (cue induced, 0-100 based VAS, craving scale) and drug cue-ERP (P300 etc. measured)
次要结局
- Changes of cognition: behavioral inhibition(the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention)
- Changes of depression status(the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention)
- Changes of anxiety status(the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention)
- Changes of sleep status(the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention)
- Changes of impulsivity(the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention)
- Changes of resting EEG network(the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention)
- Changes of cognition: working memory(the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention)