跳至主要内容
临床试验/NCT05792020
NCT05792020尚未招募不适用

Safety, Parameterization, and Mechanism of Transcranial Focused Ultrasound (fUS) Over the Motor Cortex

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2026年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
25
试验地点
2
主要终点
Motor Evoked Potential Amplitude

研究概览

简要总结

Through the BrainBox Initiative, investigators propose to study the effects of motor tFUS on Motor Evoked Potentials (MEPs) and GABA and Glutamate Concentrations in the Brain.

详细描述

tFUS is an emerging neuromodulatory tool that uses pulses of low-intensity acoustic waves to stimulate deep brain structures such as the thalamus. tFUS has recently been used to probe deep brain structures in unresponsive wakefulness, pain, anxiety, and other neuropsychiatric conditions. However, tFUS is restricted mainly by use in the MR scanner environment, thus limiting session numbers by scan cost and participant comfort. Furthermore, with few human studies to date, the parameter space and mechanisms of action warrant further elucidation. Using novel focused ultrasound methods, investigators can stimulate at a minimum penetration distance of 20mm, uniquely enabling the study of the neuromodulatory effects of tFUS on cortical tissue. Specifically, investigators propose to study the effects of motor tFUS on motor-evoked potentials (MEPs) and GABA concentration. The proposed research is critical for understanding tFUS and advancing its therapeutic potential for future clinical trials.

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
Double (Participant, Care Provider)

盲法说明

Device stimulation will be blinded by the outcomes assessor to maintain the blinding of the participants and care provider

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female
  • Age 18-55
  • Endorse good health with no history of mental or physical illness or implanted metal
  • English as a primary language
  • Capacity to consent
  • Negative urine pregnancy test if a female of childbearing potential
  • Willingness to adhere to the tFUS and MRI study schedule

排除标准

  • Any psychotropic medication is taken within 5 half-lives of procedure time
  • Any head trauma resulting in loss of consciousness
  • Personal or family history of neurological illness or injury
  • Alcohol or substance abuse or dependence (other than tobacco) in the past week
  • Diagnosis or current treatment (pharmacological or otherwise) of any psychiatric condition
  • Pregnancy
  • Personal or family history of seizures or epilepsy
  • Claustrophobia or inability to stay still in the MR scanner environment
  • Any metal in the body
  • Other contraindications to electrical or electromagnetic stimulation
  • Hair in dreadlocks, braids, or weave
  • Diagnosis of COVID-19 in the past 14 days
  • Inability to adhere to the treatment schedule.

研究组 & 干预措施

Excitatory tFUS parameters effect on Motor Evoked Potentials

Experimental

All participants will receive three sessions of Focused Ultrasound Stimulation to their motor hotspot. This stimulation cycle will operate at a 50% duty cycle.

干预措施: Focused Ultrasound Stimulation (Device)

Inhibitory tFUS parameters effect of Motor Evoked Potentials

Experimental

All participants will receive three sessions of Focused Ultrasound Stimulation to their motor hotspot. This stimulation cycle will operate at a 5% duty cycle

干预措施: Focused Ultrasound Stimulation (Device)

Sham tFUS parameters effect of Motor Evoked Potentials

Sham Comparator

All participants will receive three sessions of Focused Ultrasound Stimulation to their motor hotspot. This stimulation cycle will utilize an air-filled spacer to block stimulation from reaching the brain

干预措施: Focused Ultrasound Stimulation (Device)

结局指标

主要结局

Motor Evoked Potential Amplitude

时间窗: Immediate Post-Stimulation

How has the focused ultrasound stimulation affected MEP amplitude

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor
主要研究者

Kevin Caulfield

Principal Investigator

Medical University of South Carolina

研究点 (2)

Loading locations...

相似试验