An interventional study of Focused ultrasound in Healthy, sponsored by University of Minnesota. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-11.
Sponsored by University of Minnesota · Not applicable, Interventional, and Basic science
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.
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.
University of Minnesota is the lead sponsor of 1,210 studies on the registry; 194 are open to participants now.
Of its 133 completed or terminated interventional studies of FDA-regulated products, 92 (69%) have results posted.
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Exclusion Criteria:
Repeated measures sham control
Device: Focused ultrasound
Focused ultrasound
Reaction Time
Reaction time to visual stimulus response task
Time frame: 4 months
Plan to share: No — No sharing plan
No publications or documents are linked to this record.
Start is estimated for May 2017; primary completion for Jul 2017, 1 month later.
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This study is withdrawn, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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