Exploring the Feasibility and Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) in a Healthy Population
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Pain Sensitivity
研究概览
简要总结
Transcranial magnetic stimulation (TMS) is a neuromodulation device that is FDA-approved for use in treating depression and obsessive compulsive disorder. TMS works by applying a safe, electromagnetic field on the scalp, which can either increase or decrease neuronal communication and activity (depending on the mode of stimulation). Although it is only approved for two disorders, there has been substantial research into the potential of TMS to treat a wide range of neuropsychiatric disorders, including substance use disorders (SUDs). This project aims to develop an initial TMS protocol in a sample of healthy controls and to establish the feasibility and efficacy of using repetitive TMS (rTMS) to impact several carefully-selected cognitive, behavioral, and physiologic measures. This pilot project will enable the research team to gather baseline data using this new method and to plan longer-term programmatic studies focusing on populations with SUDs. The overarching aim of this project is to develop an rTMS protocol for use in the human laboratory setting with both healthy controls and individuals with SUDs. The investigators also hope to learn about the impact of high frequency rTMS over the DLPFC on multiple aspects of functioning including: cognitive control, impulsivity, thermal pain sensitivity, motivation, and mood.
详细描述
The short-term goal of this pilot project is to establish the feasibility and efficacy of repetitive transcranial magnetic stimulation (rTMS) on cognitive, behavioral, and physiological measures in a healthy community-recruited sample to plan longer-term programmatic studies focusing on substance use disorder (SUD) populations. Primary Aims are to examine the effect of one session of left dorsolateral prefrontal cortex (DLPFC) rTMS high-frequency (10 Hz) stimulation vs. placebo stimulation (no electromagnetic field but similar auditory and tactile sensations) on: (1) cognitive control, (2), impulsivity, and (3) thermal pain sensitivity. Secondary Aims are to test effects of rTMS on behavioral motivation (monetary incentive delay task, effort choice task), mood (PANAS), peripheral biomarkers (prolactin, BDNF) and collect biosamples for future genotyping.
The investigators recognize the proposed sample size is relatively small to adequately power a full analysis across all outcomes, so will use this study to determine effect sizes for any differences to plan future studies with adequate power. Generally speaking, data will be analyzed using repeated measures ANCOVAs; covariates will include TMS resting motor threshold, sex, and age. Based on sample size calculations, the investigators intend to complete up to 30 subjects. For some outcomes, the results of previous studies indicate that a lower sample size may be appropriate, therefore the investigators will conduct interim analyses at n=18 to calculate effect sizes to determine how many more participants are needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Participants will be blinded to the use of active vs. sham rTMS. For the sham condition, the investigators will use a placebo figure-of-8 coil, which looks identical to the active coil, allows the same scalp placement, and produces the same auditory and tactile sensations as active stimulation without affecting cortical excitability.
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Right handed
- •21-60 years of age
- •IQ score greater than 80
- •Eligible if using tobacco, alcohol, or marijuana fewer than 3 times per week; each "time" must be less than 3 cigarettes or drinks, or less than 1 marijuana "joint"
排除标准
- •Under influence of any substances during any session
- •Use of illicit substances in the past 30 days
- •Medical conditions that prohibit the use of rTMS (e.g. history of seizures or medications that lower seizure threshold)
- •Current DSM-5 Axis I psychiatric disorders, or any history of substance use disorders.
研究组 & 干预措施
Sham rTMS
Sham rTMS will be applied over the left dorsolateral prefrontal cortex using a sham figure of 8 coil (within-subject crossover). Sham rTMS will consist of the same auditory and tactile stimuli as the active condition, but does not induce an electromagnetic field and does not affect cortical excitability.
干预措施: Repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
Active rTMS
Active rTMS will be applied over the left dorsolateral prefrontal cortex using an active figure of 8 coil (within-subject crossover). In the active rTMS condition, the investigators will use high-frequency (10Hz) dorsolateral prefrontal cortex (dlPFC) stimulation with intensity of 110% of resting motor threshold. rTMS will consist of 120 trains with 50 stimuli per train (i.e. 5-sec long at 10 Hz) and 10-sec intertrain interval for a total of 6000 pulses. The entire protocol will last 30 min (120 trains with 5-sec on/10-sec off).
干预措施: Repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
结局指标
主要结局
Pain Sensitivity
时间窗: Change from pre- to 50-minutes post-rTMS stimulation in each session
Examine the effect of rTMS stimulation on pain sensitivity as measured by thermal quantitative sensory threshold (QST) testing.
Stroop Task (cognitive control)
时间窗: Change from pre- to 25-minutes post-rTMS stimulation in each session
Examine the effect of rTMS stimulation on cognitive control as measured by the Stroop Color-Word task.
Stop Signal Task (impulsivity)
时间窗: Change from pre- to 15-minutes post-rTMS stimulation in each session
Examine the effect of rTMS stimulation on impulsivity as measured by the Stop Signal Task.
Delay Discounting Task (cognitive control)
时间窗: Change from pre- to 10-minutes post-rTMS stimulation in each session
Examine the effect of rTMS stimulation on cognitive control as measured by the brief (2-min) monetary delay discounting task
次要结局
- Mood(Change from pre- to 5-minutes post-rTMS stimulation in each session)
- Peripheral Biomarkers(Change from pre- to 0-minutes post-rTMS stimulation in each session)
- Monetary Incentive Delay Task (motivation)(Change from pre- to 40-minutes post-rTMS stimulation in each session)
- Effort Choice Task (motivation)(Change from pre- to 30-minutes post-rTMS stimulation in each session)
研究者
Mark Greenwald, PhD
Professor and Associate Department Chair
Wayne State University