Theta Burst TMS as a Tool to Change Smoking Behavior
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Percent BOLD signal change in the MPFC
研究概览
简要总结
The goal of this study is to determine whether transcranial magnetic stimulation (TMS) is an effective treatment in decreasing craving in individuals who habitually smoke cigarettes. The study consists of six total visits to MUSC; one for the consent process, two that will include MRI scans, and five that will include TMS administration. Compensation will be provided for each visit.
详细描述
Prior and recent evidence suggests a role of medial prefrontal cortex (mPFC) in cigarette smoking. The present study will examine whether a five-day regimen of theta-burst transcranial magnetic stimulation (TMS) reduces cigarette smoking outside of the lab (examined through self-report and physiological measures) and motivation to smoke inside the lab (examined through behavioral tasks and functional MRI).
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
- •smoke at least 10 cigarettes a day (on average)
排除标准
- •comorbid mental or physical illness (managed or unmanaged)
- •pregnancy
- •use of prescription medication that might affect smoking or nicotine metabolism,
- •use of smokeless tobacco or alternative nicotine products
- •use illicit drugs of abuse (verified through urine screen and self-report),
- •score of above a 7 on the Alcohol Use Disorders Identification Test (indicative of non-risky use),
- •a history of epilepsy or seizures not otherwise specified (other than childhood febrile seizures)
- •a history of chronic migraines,
- •failure to meet all criteria on a standardized MRI/TMS safety screen (including but not limited to implanted electronic devices, bullets or metallic fragments above the waist, hair clips and piercings above the waist that cannot be removed)
- •presence of any barriers to making contact between the TMS coil and the skin (e.g. cornrows that cannot be removed, glasses that the participant is unwilling to remove).
结局指标
主要结局
Percent BOLD signal change in the MPFC
时间窗: immediately after the treatment
The effect of real vs. sham cTBS to the leftt MPFC as a tool to modulate the brain response to craving will be assessed by comparing the brain activity in the limbic circuit before and after TMS.
次要结局
未报告次要终点