Closed-loop Transcranial Temporal Interference Stimulation Targeted of the Nucleus Accumbens as an Intervention for Methamphetamine Use Disorder Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change of Craving
研究概览
简要总结
Closed-loop transcranial temporal interference stimulation (tTIS) targeting the nucleus accumbens may modulate abnormal neural responses to drug-related cues in individuals with methamphetamine use disorder (MUD), thereby reducing drug craving and improving cognitive and behavioral control. Stimulation will be delivered in real time according to each patient's cue-induced response time.
详细描述
This project will recruit individuals with methamphetamine use disorder. Participants will receive closed-loop transcranial temporal interference stimulation targeting the nucleus accumbens once daily for five consecutive days. During each intervention session, participants will be exposed to methamphetamine-related cues, and stimulation will be triggered according to their response time.
Before and after the intervention, clinical questionnaires and behavioral tasks will be administered to evaluate changes in drug craving, methamphetamine-use-related symptoms, inhibitory control, and reward-related decision-making. Cue-induced neural responses will also be assessed to investigate the neural mechanisms through which closed-loop tTIS targeting the nucleus accumbens may alleviate craving and improve addiction-related cognitive and behavioral dysfunction.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged between 18 and 55 years, irrespective of gender, having completed a minimum of 9 years of education and capable of effectively cooperating in questionnaire evaluations.
- •Meet the diagnostic criteria set forth by the DSM-V concerning the amphetamine-type substance addiction.
- •A history of utilizing amphetamine-type substances for a duration not less than one year, with a frequency of use being at least once per week.
- •Consent to actively cooperate in the completion of subsequent follow-up assessments.
排除标准
- •Severe cognitive functional impairments manifested through a history of head trauma, cerebrovascular diseases, epilepsy, etc., or usage of cognitive enhancement drugs in the past 6 months; an intellectual disability with an IQ score less than
- •A diagnosis of schizophrenia or other severe mental illnesses as per the DSM-5 criteria.
- •Abuse or dependence on other psychoactive substances (excluding nicotine) within the past 5 years.
- •Severe organic diseases that might compromise study participation.
- •Contraindications to cTBS, such as a history of epileptic seizures or the presence of metallic implants in proximity to the head.
研究组 & 干预措施
Temporal Interference Stimulation Group
The first pair of electrodes continuously delivers a current at a frequency of f1 = 2 kHz, while the second pair delivers a current at f2 = 2.130 kHz. Based on the principle of temporal interference, an alternating electric field at a frequency of f1 - f2 = 130 Hz is generated in the target region.
干预措施: Temporal Interference Stimulation (Device)
Control Group
The stimulation parameters-including frequency, current intensity, and duration-are identical to those in the active group. However, the sham stimulation mode is activated on the device, resulting in no actual current being delivered during the stimulation.
干预措施: Shame (Device)
结局指标
主要结局
Change of Craving
时间窗: baseline, 1 day after treatment, 1 month after treatment
Visual Analog Scale, range0-100 point. the higher the score, the more one wants drugs.
次要结局
- Obsessive-Compulsive Drug Use Scale score(baseline, 1 day after treatment, 1 month after treatment)
- Dual-Mode of Self-Control Scale-Impulsive System score(baseline, 1 day after treatment, 1 month after treatment)
- Dual-Mode of Self-Control Scale-Control System score(baseline, 1 day after treatment, 1 month after treatment)
- Stop Single Task(baseline, 1 day after treatment, 1 month after treatment)
- EEG ERP amplitude during the Stop-Signal Task(baseline, 1 day after treatment, 1 month after treatment)
- Decision-making Preferences and Delay of Gratification(baseline, 1 day after treatment, 1 month after treatment)
- Changes in Reward Learning(baseline, 1 day after treatment, 1 month after treatment)
- sensitivity to reward and punishment(baseline, 1 day after treatment, 1 month after treatment)
- Behavioral Inhibition/Activation System Scale(baseline, 1 day after treatment, 1 month after treatment)
- Beck Depression Inventory-II score(baseline, 1 day after treatment, 1 month after treatment)
- Drug-cue Flanker task(baseline, 1 day after treatment, 1 month after treatment)
- EEG theta power(baseline, 1 day after treatment, 1 month after treatment)
- EEG P3 amplitude(baseline, 1 day after treatment, 1 month after treatment)