The Exploration of Novel Cross-frequency Protocol of Transcranial Alternating Current Stimulation in the Treatment of Methamphetamine Use Disorder: A Randomized Sham-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change of Craving assessed by Visual Analog Scale
研究概览
简要总结
The purpose of this research is to evaluate the efficacy of multiple sessions of theta-gamma cross-frequency transcranial alternating current stimulation in patients with methamphetamine (MA) use disorders.
详细描述
Previous evidence suggests that different aspects of cognitive function are associated with activities of distinct EEG frequency bands. Gamma oscillatory has been found in clinical studies to reflect the processing of rewards in patients with drug dependence, whereas medial prefrontal theta oscillatory characterizes prefrontal response inhibition capacity to downstream reward arousal. Interestingly, impaired response inhibition or impaired evaluation of rewards in patients with drug dependence have been found to correlate with the arousal of psychological craving and the emergence of relapse. Here we aim to find causal evidence supporting these previous correlational findings by applying cross-frequency transcranial alternating current stimulation (tACS) in the specific frequency bands (theta-gamma) previously shown to be addiction-relevant. In a randomized control clinical trial design, we stimulate subjects with either theta-gamma or sham tACS. Electroencephalography will be collected before and after each treatment session. Besides, the scale and behavior task data will also collected before and after the treatment.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders
- •Normal vision and hearing
- •Dextromanual
- •Use MA not less than 1 year, and the last of MA use no less than 3 months
排除标准
- •Have a disease that affects cognitive function such as a history of head injury, cerebrovascular disease, epilepsy, etc
- •Have cognitive-promoting drugs in the last 6 months
- •Other substance abuse or dependence in recent five years (except nicotine)
- •Meet the DSM-5 criteria for other mental disorders
- •Physical disease
研究组 & 干预措施
Experimental: theta-gamma tACS
The study is investigating the use of transcranial alternating current stimulation (tACS). For the experimental arm, the stimulation is delivered at 2 milliamperes (mA) with the stimulation electrode over the left prefrontal cortex (F3) and left orbitofrontal cortex (Fp1) using the cross-frequency stimulation waveform theta-gamma.
干预措施: Cross-frequency transcranial alternating current stimulation via the Neuroelectrics Starstim 32 transcranial electric stimulation device (Device)
Active-sham tACS
For the active sham stimulation, the stimulation is delivered for 12 seconds with the theta-gamma cross-frequency stimulation waveform and then returns to baseline. The stimulus parameter of the sham stimulation is designed to mimic the adaptive sensations experienced by the subject when receiving the real stimulation treatment settings, but no effective brain modulation will be produced, which assists with blinding the participant's assignment.
干预措施: Cross-frequency transcranial alternating current stimulation via the Neuroelectrics Starstim 32 transcranial electric stimulation device (Device)
结局指标
主要结局
Change of Craving assessed by Visual Analog Scale
时间窗: baseline，0-2 days after treatment，1 months after treatment, 3 months after treatment
evaluate all participants' craving for for methamphetamine assessed by Visual Analog Scales (VAS). Score of VAS range from 0 to 10, and higher values represent high level of craving.
次要结局
- Sleep Quality Assessment(baseline，0-2 days after treatment，1 months after treatment, 3 months after treatment)
- Brain oscillations(baseline，within 30 minutes before and after each session of treatment)
- Spatial working memory(baseline，0-2 days after treatment, 3 months after treatment)
- Depression status assessed by Beck Depression Inventory (BDI)(baseline，0-2 days after treatment，1 months after treatment, 3 months after treatment)
- Anxiety status assessed by Beck Anxiety Inventory (BAI)(baseline，0-2 days after treatment，1 months after treatment, 3 months after treatment)
- Reward learning(baseline，0-2 days after treatment, 3 months after treatment)