The Effects of Transcranial Focused Ultrasound on Human Motor Learning

Healthy Clinical Trial

Official title:

The Effects of Transcranial Focused Ultrasound on Human Motor Learning

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03130647
• Other study ID #: M1 ultrasound
• Status: Withdrawn
• Phase: N/A
• First received: March 16, 2017
• Last updated: September 8, 2017
• Start date: May 15, 2017
• Est. completion date: July 1, 2017

Study information

• Verified date: September 2017
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 1, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18 to 65 years of age Provide written informed consent

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

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Focused ultrasound
Focused ultrasound

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reaction Time	Reaction time to visual stimulus response task	4 months