Individualized Neuromodulation Intervention Techniques for the Core Clinical Features of Drug Addiction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 3
- 主要终点
- Visual Analog Scale for craving (VAS-Craving)
研究概览
简要总结
Using specific EEG biomarkers in methamphetamine-dependent individuals, this study systematically probes the effect of closed-loop tACS based on brain states
详细描述
Methamphetamine use disorder (MUD) addiction represents a severe public health concern. Individuals addicted to methamphetamine exhibit intense cravings and physiological reactions when exposed to addiction-related cues, a phenomenon termed "cue reactivity." Cue reactivity is a critical factor in the development and persistence of addiction. Impairments in inhibitory control are considered a significant factor contributing to the emergence of cue reactivity. Conventional pharmacological and physical interventions suffer from low efficiency and high effect variance. Closed-loop physical interventions, which adjust stimulation parameters in real-time based on brain state, are an innovative approach with the potential to enhance the precision and efficiency of treatments. Closed-loop interventions based on transcranial alternating current stimulation (tACS) hold promise as a novel therapeutic method for treating methamphetamine addiction. This study aims to develop and evaluate the effect of closed-loop tACS on cue reactivity and inhibition control function in MUD. Therefore, the investigators intend to employ the non-invasive tACS technique, predicated upon biomarkers of addiction states, to administer specific frequency stimulations to targeted brain regions, aiming to achieve therapeutic objectives in addiction treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 or are capable of effectively cooperating in questionnaire evaluations.
- •Meet the diagnostic criteria set forth by the DSM-5 concerning the severity of amphetamine-type substance addiction.
- •A history of utilizing amphetamine-type substances for a duration not less than one year, with a frequency of use of 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 tACS, include a history of epileptic seizures or the presence of metallic implants in proximity to the head.
研究组 & 干预措施
Closed-loop tACS stimulation based on addiction-induced states
In the initial phase of this study, participants will receive individualized closed-loop tACS interventions once daily for five consecutive days. Concurrently, they will be exposed to MA-related cue paradigms to induce cue-reactivity states, while scalp EEG signals are collected. Stimulation will be initiated only upon identifying specific neural signals associated with MA cues.
干预措施: Closed-loop tACS stimulation based on addiction-induced states (Device)
结局指标
主要结局
Visual Analog Scale for craving (VAS-Craving)
时间窗: through study completion, an average of 5 days
The intensity of psychological craving in MA dependents was assessed using the Visual Analogue Scale for craving (VAS-Craving), where individuals rated their cravings on a scale from 0 to 100, with higher scores indicating greater levels of craving. The VAS scores were utilized based on two conditions: during a resting state and when subjected to cue induction involving images associated with methamphetamine, serving as the criteria for evaluation.
次要结局
- Obsessive Compulsive Drug Use Scale (OCDUS)(through study completion, an average of 5 days)
- Stop-signal task(through study completion, an average of 5 days)