The Effects of Transcranial Focused Ultrasound on Human Motor Learning

NCT03130647 | Withdrawn FDA Device

• 1 other identifier: M1 ultrasound
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Reaction Time

  Reaction time to visual stimulus response task

  4 months

Study Arms (1)

Focused ultrasound

EXPERIMENTAL

Repeated measures sham control

Device: Focused ultrasound

Interventions

Focused ultrasound DEVICE

Focused ultrasound

Focused ultrasound

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 65 years of age Provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Repeated measures sham controlled

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: April 26, 2017
• Study Start: May 15, 2017
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: September 11, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)