TMS (Transcranial Magnetic Stimulation) for Methamphetamine Use Disorder in People Living With HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Cue-induced methamphetamine craving
研究概览
简要总结
The purpose of this study is to learn more about how accelerated theta burst stimulation affects methamphetamine craving and brain activity. Theta burst stimulation is a unique transcranial magnetic stimulation (TMS) paradigm that is efficient and potent.
详细描述
The investigators will compare how two theta burst paradigms, intermittent theta burst stimulation (iTBS) and continuous theta burst stimulation (cTBS), compare with sham TMS in changing methamphetamine craving and brain activity. iTBS, cTBS, and sham TMS will be delivered in an accelerated fashion (two sessions daily, separated by 50 minutes). iTBS will be delivered to the left dorsolateral prefrontal cortex (left dorsolateral prefrontal cortex), and cTBS will be delivered to the frontal pole. A brain MRI scan will be done before and after the iTBS/cTBS/sham TMS sessions. The study involves four visits. Each visit will last three hours. Hence, participants will spend a total of 12 hours in the study.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults in the age group 18-65 years
- •Able to read and understand English
- •Able to provide informed consent
- •Diagnosed with HIV
- •History of current or previous Methamphetamine Use Disorder
- •Endorse craving for methamphetamine
- •Demonstrate an attentional bias for methamphetamine
排除标准
- •Traumatic brain injury
- •h/o seizure disorder
- •h/o or current diagnosis of schizophrenia
- •intracranial metal shrapnel
- •previous adverse effects with TMS
- •sub-threshold consistency while performing behavioral tasks
- •lack of attentional bias to methamphetamine cues
- •a positive pregnancy test for female participants
- •abnormal brain MRI
研究组 & 干预措施
Group 1
Group 1 will receive actual TMS (iTBS and cTBS) on days 2 and 3 and sham TMS on day 4.
干预措施: Sham TMS (Device)
Group 2
Group 2 will receive actual TMS (iTBS and cTBS) on days 2 and 4 and sham TMS on day 3.
干预措施: intermittent theta burst stimulation (iTBS) (Device)
Group 2
Group 2 will receive actual TMS (iTBS and cTBS) on days 2 and 4 and sham TMS on day 3.
干预措施: Sham TMS (Device)
Group 3
Group 3 will receive sham TMS on day 2 and actual TMS (iTBS and cTBS) on days 3 and 4.
干预措施: intermittent theta burst stimulation (iTBS) (Device)
Group 3
Group 3 will receive sham TMS on day 2 and actual TMS (iTBS and cTBS) on days 3 and 4.
干预措施: continuous theta burst stimulation (cTBS) (Device)
Group 3
Group 3 will receive sham TMS on day 2 and actual TMS (iTBS and cTBS) on days 3 and 4.
干预措施: Sham TMS (Device)
Group 1
Group 1 will receive actual TMS (iTBS and cTBS) on days 2 and 3 and sham TMS on day 4.
干预措施: intermittent theta burst stimulation (iTBS) (Device)
Group 1
Group 1 will receive actual TMS (iTBS and cTBS) on days 2 and 3 and sham TMS on day 4.
干预措施: continuous theta burst stimulation (cTBS) (Device)
Group 2
Group 2 will receive actual TMS (iTBS and cTBS) on days 2 and 4 and sham TMS on day 3.
干预措施: continuous theta burst stimulation (cTBS) (Device)
结局指标
主要结局
Cue-induced methamphetamine craving
时间窗: Baseline and before and after each TMS session up to 4 days
Measured on the visual analog scale (VAS) Scored 0 to 100 with 0=no craving and 100=the most craving.
次要结局
未报告次要终点
研究者
Gopalkumar Rakesh
Assistant Professor
University of Kentucky