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临床试验/NCT03130647
NCT03130647撤回不适用

The Effects of Transcranial Focused Ultrasound on Human Motor Learning

University of Minnesota2 个研究点 分布在 1 个国家开始时间: 2017年5月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Reaction Time

研究概览

简要总结

Transcranial focused ultrasound (tFUS) is a form of neuromodulation that uses a single element transducer to produce highly focused low-intensity acoustic energy that can be used to affect cortical excitability in humans.

详细描述

Here the investigator plan to investigate the effect of tFUS on motor behavior. M1 has been chosen for two fundamental reasons for this study: 1) The use of muscle contraction to generate a detectable evoked potential signal allows for targeting of a precise area within M1 with tFUS, and 2) It is known that M1 is involved in fast learning of sequential motor tasks By targeting M1 with tFUS in neurologically healthy volunteers, we can study the effects of tFUS on motor learning measures (e.g., reaction time, accuracy) while a subject is performing a finger tapping motor learning task. If ultrasound is proven efficacious for stimulating the motor cortex, non-surgical ultrasound could potentially replace costly and risky surgery for the treatment of brain disorders as is common with deep brain stimulation for essential tremor or Parkinson's disease. There is currently no way to affect brain tissue deep into the cortex without surgery, genetic alteration or viral vectors (the latter two are not approved for human use). This technology is non-surgical and as invasive as any diagnostic ultrasound exam. With success, transcranial focused ultrasound could become useful world-wide as a cheap, portable and effective tool for human brain mapping efforts as well as for the diagnosis and potential treatment of a broad range of psychiatric and neurological disorders.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 to 65 years of age Provide written informed consent

排除标准

  • Evidence of a current significant medical illness or psychiatric or central or peripheral neurologic disorder History of loss of consciousness of more than ten minutes in the past year or loss of consciousness in a lifetime that required rehabilitation services Personal or family history of seizure Any history of stroke/transient ischemic attack (TIA) Taking any medications that may decrease the threshold for seizure Pregnancy Affirmative answers to one or more questions of the provided attached safety questionnaires. These are not absolute contraindications to this study but the risk/benefit ratio will be carefully balanced by the PI Left handedness. Failure to follow laboratory or study procedures

研究组 & 干预措施

Focused ultrasound

Experimental

Repeated measures sham control

干预措施: Focused ultrasound (Device)

结局指标

主要结局

Reaction Time

时间窗: 4 months

Reaction time to visual stimulus response task

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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