Closed-loop Neuromodulation Based on Individualised EEG Biomarkers of Methamphetamine Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change of Craving assessed by Visual Analog Scale (VAS)
研究概览
简要总结
Using specific EEG biomarkers in methamphetamine-dependent individuals, this study systematically probes closed-loop continuous Theta-burst Stimulation (cTBS) based on brain states, assessing dosage, neurologic and behavioral effects, while comparing its efficacy with traditional open-loop cTBS methods.
详细描述
The current study delineates a robust correlation between prefrontal cortex EEG signals and the psychological craving associated with methamphetamine usage. Dependents exhibit heightened β oscillation energy in the MPFC region and diminished γ oscillation energy across the DLPFC-MPFC region. Previously, through the implementation of rTMS interventions on the left DLPFC, the investigators have successfully reduced the craving levels in users when exposed to relevant cues, coupled with observed decreases in β oscillation energy and increases in γ oscillation energy in the MPFC region. This indicates that both β and γ oscillation energies are instrumental in representing the involvement of MPFC and DLPFC during craving episodes, and neuromodulatory technologies can modulate these energy levels, consequently reducing cravings. Furthermore, the investigators identified a significant augmentation in the theta energy in the occipital lobe when MA dependents are confronted with drug-related cue imagery, signifying a potential crucial neural marker for addiction-induced brain activity. Therefore, the investigators intend to employ the non-invasive continuous Theta-burst Stimulation (cTBS) , 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged between 18 and 60 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.
结局指标
主要结局
Change of Craving assessed by Visual Analog Scale (VAS)
时间窗: through study completion, an average of 1 month
The intensity of psychological craving in MA dependents was assessed using the Visual Analogue Scale (VAS), where individuals rated their cravings on a scale from 0 to 10, 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. individuals rated their cravings on a scale from 0 to 10, 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
- Changes of electroencephalogram power spectrum(through study completion, an average of 1 month)
- sleep quality(through study completion, an average of 1 month)
- Anxiety(through study completion, an average of 1 month)
- Probabilistic inversion learning task(through study completion, an average of 1 month)
- Depression(through study completion, an average of 1 month)