The Effects of Transcranial Focused Ultrasound on Human Motor Learning

Not Applicable

Withdrawn

• Conditions: Healthy
• Interventions: Device: Focused ultrasound

• Registration Number: NCT03130647
• Lead Sponsor: University of Minnesota

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-03-16
• Study First Submitted QC: 2017-04-24
• Study First Posted: 2017-04-26
• Study Start: 2017-05-15
• Primary Completion: 2017-07-01
• Study Completion: 2017-07-01
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-08
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 18 to 65 years of age Provide written informed consent

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Focused ultrasound	Focused ultrasound	Repeated measures sham control

Primary Outcome Measures

Name	Time	Method
Reaction Time	4 months	Reaction time to visual stimulus response task

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States