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临床试验/NCT04192149
NCT04192149Unknown不适用

The Effects of Ultrasound on Central Nervous System

University of Virginia2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年2月19日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
2
主要终点
Electrophysiological Changes as a result of Ultrasound

研究概览

简要总结

Focused ultrasound at low intensities is a form of neuromodulation with high spatial resolution that can be applied invasively or non-invasively using acoustic energy to affect neuronal activity. The purpose of this study is to better understand the effects of low intensity focused ultrasound (FUS) on the central nervous system. Specific patient populations within UVA health system are undergoing treatment that provide unique opportunities to study these effects.

详细描述

Focused ultrasound (FUS) at low intensities is a form of neuromodulation with high spatial resolution that can be applied invasively or non-invasively using acoustic energy to affect neuronal activity. In this study the investigators intended to use specific patient populations to investigate the effects of FUS on different areas of the central nervous system (CNS). Each of our patients groups is undergoing a unique procedure at University of Virginia that will provide us different insights into the CNS. (1) Patients receiving an awake or asleep craniotomy for brain tumors and/or epilepsy will undergo a brain mapping procedure using electrical stimulation as a part of their normal care. The research procedures will duplicate this mapping with an invasive FUS mapping. (2) Patients undergoing long term monitoring for epilepsy will receive a non-invasive form of FUS stimulation which will be measured by their EEG cap and intracranial electrodes which are a part of their normal care. (3) Patients undergoing high intensity FUS treatment for tremor will be asked to wear a research provided EEG cap while undergoing a non-invasive low intensity FUS research procedure and changes in their tremor will be monitored. (4) Patients undergoing Deep Brain Stimulation (DBS) treatment for tremor will receive a non-invasive FUS stimulation observed through their newly implanted electrode. (5) Patients receiving a spinal surgery will undergo a spinal stimulation using electrical stimulation as a part of their normal care. The research procedures will duplicate this with an invasive FUS stimulation.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Be a patient receiving a treatment or surgical procedure specified below:
  • Receiving a Craniotomy with brain mapping
  • Receiving treatment or monitoring for Epilepsy
  • Receiving either FUS or DBS treatment for Tremor
  • Receiving a Spinal Surgery for stimulator placement
  • Able to provide informed consent
  • Must speak English
  • Age 18-85

排除标准

  • Not receiving one of the specified inclusion procedures
  • Unable to provide consent
  • Women who self-report pregnancy
  • Patients who are currently incarcerated

结局指标

主要结局

Electrophysiological Changes as a result of Ultrasound

时间窗: baseline, immediately after ultrasound (same day, approximately 5-10 minutes after baseline)

Each participant group has different type of electrophysiological recording depending on the type of procedure. Recordings will include a baseline, during ultrasound, and/or post-ultrasound electrophysiology.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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