Cortical Excitability in Cyclic Vomiting Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Paired-pulse ratios
研究概览
简要总结
This exploratory study will determine if there are differences in cortical excitability between patients suffering from cyclic vomiting syndrome (CVS) and healthy control subjects, as assessed by a non-invasive method of brain stimulation (Transcranial Magnetic Stimulation, TMS).
详细描述
This exploratory study will determine if there are differences in cortical excitability between patients suffering from cyclic vomiting syndrome (CVS) and healthy control subjects, as assessed by a non-invasive method of brain stimulation (Transcranial Magnetic Stimulation, TMS).
Using the paired-pulse TMS paradigm, intracortical inhibition and facilitation of cortical circuitry will be assessed by stimulating the motor cortex and using the electromyographic (EMG) response of a target muscle as readout. In such studies, a conditioning stimulus modulates the amplitude of the motor-evoked potential (MEP) produced by the test stimulus. Depending on the inter-stimulus interval, effects can be attributed to different aspects of cortical processing. Brief intervals (1-5 ms) will be used to assess short-interval intracortical inhibition (SICI) and short-interval intracortical facilitation (SICF), intermediate intervals (7-20 ms) to assess intracortical facilitation (ICF) and long intervals (50-200 ms) to assess long-interval intracortical inhibition (LICI).
Some clinical, demographic, and autonomic data (i.e. EKG) will be recorded and used as covariates to investigate any systematic impact on cortical excitability measures collected with the paired-pulse protocols.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •diagnosis of CVS
排除标准
- •history of CVS (for healthy control population only)
- •psychosis or altered cognitive status
- •history of head injury, metal in the skull, stroke, or a history of seizures or a history of syncope (fainting or passing out)
- •implantable devices, such as a pacemaker or nerve stimulator
- •current use of the following medications or use of substances which are known to lower the seizure threshold: clozapine (Clozaril), chlorpromazine (Thorazine), amphetamines or methamphetamine, Ecstasy, Ketamine, Angel Dust/PCP, cocaine, or 3 or more alcoholic drinks per day
- •pregnancy
研究组 & 干预措施
CVS subjects
Subjects diagnosed with Cyclic Vomiting Syndrome (CVS)
干预措施: Autonomic activity (Other)
healthy, non-CVS subjects
Subjects not diagnosed with CVS
干预措施: TMS Paired-Pulse assessment of cortical excitability (Other)
healthy, non-CVS subjects
Subjects not diagnosed with CVS
干预措施: Autonomic activity (Other)
CVS subjects
Subjects diagnosed with Cyclic Vomiting Syndrome (CVS)
干预措施: TMS Paired-Pulse assessment of cortical excitability (Other)
结局指标
主要结局
Paired-pulse ratios
时间窗: Multiple study sessions spanning up to 12 months
Percentage Change in Paired Pulse (PP) TMS induced MEP responses with inhibitory or facilitatory stimulation.
次要结局
- Cortical silent period(Multiple study sessions spanning up to 12 months)
- Heart rate variability(Multiple study sessions spanning up to 12 months)
- TMS motor threshold(Multiple study sessions spanning up to 12 months)
研究者
David Levinthal
Assistant Professor
University of Pittsburgh