跳至主要内容
临床试验/NCT05924009
NCT05924009
招募中
不适用

Characterization of Gastric Evoked Potentials

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 155 人2023年6月17日

概览

阶段
不适用
干预措施
Transcranial Magnetic Stimulation, TMS
疾病 / 适应症
Healthy
发起方
University of Pittsburgh
入组人数
155
试验地点
1
主要终点
Change in GEP hotspot location
状态
招募中
最后更新
3个月前

概览

简要总结

This is an exploratory study that will determine and standardize how best to record gastric evoked potentials (GEPs) elicited by a non-invasive method of brain stimulation (Transcranial Magnetic Stimulation, TMS), by optimizing the TMS parameters and cortical sites necessary to evoke GEPs.

详细描述

The overall goal of this exploratory study is to determine the optimal conditions to elicit gastric evoked potentials (GEPs) with Transcranial Magnetic Stimulation (TMS). Aim 1: Determine the optimal stimulation parameters and the optimal location for eliciting GEPs in cortical motor areas. Aim 2: Determine whether various modes of repetitive TMS (rTMS) neuromodulation targeted to GEP hotspots shape gastric motor responses to a water load. The investigators will record some clinical, demographic, and autonomic data (i.e. EKG) in our enrolled subjects. Secondary analyses will use these variables as covariates to investigate any systematic impact on the measures from Aims 1 and 2.

注册库
clinicaltrials.gov
开始日期
2023年6月17日
结束日期
2026年12月1日
最后更新
3个月前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Principal Investigator
主要研究者

David Levinthal

Associate Professor

University of Pittsburgh

入排标准

入选标准

  • 未提供

排除标准

  • psychosis or altered cognitive status
  • history of head injury, metal in the skull, stroke, or a history of seizures, loss of consciousness or syncope
  • implantable devices, such as a pacemaker or nerve stimulator
  • current use of antiepileptic medications or current use of the following medications or 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
  • BMI \> 30
  • history of bariatric surgery such as sleeve gastrectomy or Roux-en-Y gastric bypass
  • suffering from a neurodegenerative disorder.

研究组 & 干预措施

All participants

All participants

干预措施: Transcranial Magnetic Stimulation, TMS

结局指标

主要结局

Change in GEP hotspot location

时间窗: Multiple study sessions spanning up to 12 months

Stimulation location evoking the largest GEP response, relative to FDI hotspot location

Change in optimal stimulation parameters at GEP hotspot

时间窗: Multiple study sessions spanning up to 12 months

Stimulation pattern (single pulses or brief bursts) and strength relative to MT for FDI

次要结局

  • Effect of satiety(Multiple study sessions spanning up to 12 months)
  • Effect of neuromodulation(Multiple study sessions spanning up to 12 months)

研究点 (1)

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