Optimizing Transcranial Magnetic Stimulation for Stimulant Use Disorder
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- TEP individual response
研究概览
简要总结
The study will recruit 50 adults with stimulant use disorder currently in treatment and abstinent for at least 2 weeks. The study will also recruit up to 10 healthy controls (adults without StUD) for initial study configuration. The study will consist of five steps that are expected to be completed over two lab visits.
Step 1: The 3T MRI scan will provide accurate prefrontal cortex anatomy for using neuronavigation for TMS. In addition, the study will use an analysis of resting fMRI connectivity to determine the location in the left DLPFC that has the maximum connectivity with the incentive-salience network.
Step 2: The study will use the data collected at the MRI to select the individual TMS location. EEG will be used to collect TEPs in response to single pulse TMS at the left DLPFC. Participants will then be randomized to one of three conditions: A) TMS unsynchronized with EEG, B) TMS synchronized with EEG theta frequency trough, and C) TMS synchronized with EEG theta frequency peak. The stimulation will be applied with an intensity of up to 120% of the resting motor threshold (which is a safe and common practice; Rossi et al., 2021). The intensity can be decreased for individual participants.
Step 3: Following randomization, the study will administer a pre-iTBS assessment.
Step 4: The study will compare brain and behavioral responses before and after the iTBS session with TMS and EEG synchronization as assigned by their randomized group.
Step 5: The study will administer a post-iTBS assessment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 or older
- •Ability to provide consent and comply with all study procedures.
- •Meets Diagnostic and Statistical Manual of Mental Disorders criteria for StUD (As assessed by MINI and self-report; Participants may have current comorbid drug use, but primary diagnosis must be StUD; does not apply to healthy control participants).
- •At least 2 weeks of abstinence from substance use (other than caffeine or nicotine).
- •Intention to remain in an addiction treatment program until intervention completion (does not apply to healthy control participants).
- •Confident level of English language proficiency.
排除标准
- •Any organic brain disorder (e.g. TBI, stroke).
- •Head injury resulting in skull fracture or loss of consciousness exceeding 30 minutes.
- •TMS contraindication (history of seizures, metallic cranial plates/screws or implanted device).
- •MRI contraindications (unapproved metallic implants, pacemakers or any other implanted electrical device, shrapnel, metallic braces, non-removable body piercings, pregnancy, breathing or movement disorder, claustrophobia).
- •Any psychotic disorder (Participants with other treated and stable psychiatric disorders will be included).
- •Presence of a condition that would render study measures impossible to administer or interpret.
- •Primary current substance use disorder diagnosis on a substance other than stimulants or cocaine, except for caffeine or nicotine.
- •Greater than 9 months abstinence from substance use (does not apply to healthy control participants).
- •Pregnancy or breastfeeding.
研究组 & 干预措施
Group 1
Participants assigned to closed-loop-peak
干预措施: closed-loop-peak (Other)
Group 2
Participants assigned to open-loop
干预措施: Open-loop (Other)
Group 3
Participants assigned to closed-loop-trough
干预措施: closed-loop-trough (Other)
结局指标
主要结局
TEP individual response
时间窗: 2 hours
Use TMS-evoked potentials (TEPs) to assess individual response to three TMS-EEG synchronization methods: random, peak, and trough.
Cognitive response
时间窗: Measured immediately after the iTBS
Investigate the CSST task cognitive response to three TMS-EEG synchronization approaches during intermittent Theta Burst Stimulation (iTBS).
次要结局
未报告次要终点