Recruiting

Observational Study

Sponsor:

University of Virginia

Code:

NCT04168086

Conditions

Healthy Participants

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

Focused Ultrasound

Sham

Study Details

Brief summary:

Transcranial focused ultrasound stimulation (tFUS) will be used in this study to functions of the cerebellum in human motor learning. Participants will complete a visuomotor task while receiving stimulation pulses from tFUS. How tFUS stimulation influencing the acquisition and retention of motor memory will be assessed based on group comparison of behavioral measures such as reaching accuracy.

Conditions

Healthy Participants

Study ID

NCT04168086

Start date

Jan 28, 2019

Status verified date

Nov, 2019

Completion date

Jan 27, 2020

Anticipated

Primary completion date

Jan 27, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Healthy, adult subjects
  • 18 to 35 years of age
  • Right-handed
  • Provide written informed consent

Exclusion Criteria:

  • Presence of a psychiatric or neurologic illness
  • 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) or severe traumatic brain injury
  • Taking any medications that may decrease the threshold for seizure
  • Pregnancy (self-reported)
  • 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
  • Have any type of metal in the body
  • Failure to follow laboratory or study procedures

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Right Motor Area Cerebellum

Participants will receive Focused Ultrasound stimulation to motor area of the right cerebellum prior to completing a motor learning task.

experimental: Non-Motor Area Cerebellum

Participants will receive Focused Ultrasound stimulation to a non-motor area of the right cerebellum prior to completing a motor learning task.

sham comparator: Control

Participants will have the Focused Ultrasound transducer placed on their neck without stimulation as a Sham present prior to completing a motor learning task.

Interventions

Focused Ultrasound

Low intensity focused ultrasound is sound energy stimulation at a low intensity of 1-30 W/cm2

Sham

The investigators will simulate focused ultrasound stimulation similar to the experimental groups but without stimulation.

Primary outcome measure

  • Performance Error on Visuomotor Task [ Time Frame: baseline, immediately after FUS, and 30 minutes after FUS ]

Central Contacts and Locations

Central contacts

Sarah Adams

434-243-4319neuromodlab@hscmail.mcc.virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Sarah Adams

434-243-4319neuromodlab@hscmail.mcc.virginia.edu

More Information

Sponsor

University of Virginia

Last update posted

Nov 19, 2019

Last verified

Nov, 2019

Keywords

  • Ultrasound
  • Neuromodulation
  • Cerebellum
  • Transcranial Ultrasound Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2019-11-19.