Cerebellar Functions in Visuomotor Adaptation

NCT04168086 | Unknown

• 1 other identifier: 21135
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Keywords

Ultrasound; Neuromodulation; Cerebellum; Transcranial Ultrasound Stimulation

Outcome Measures

Primary Outcomes (1)

• Performance Error on Visuomotor Task

  The visuomotor task has practice, baseline, and experimental trials. Performance on the task will be compared between groups.

  baseline, immediately after FUS, and 30 minutes after FUS

Secondary Outcomes (1)

• Changes in Motor Evoked Potentials (MEP)

  baseline, immediately after FUS, 10 minutes after FUS, and 20 minutes after FUS

Study Arms (3)

Right Motor Area Cerebellum

EXPERIMENTAL

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

Other: Focused Ultrasound

Non-Motor Area Cerebellum

EXPERIMENTAL

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

Other: Focused Ultrasound

Control

SHAM COMPARATOR

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

Other: Sham

Interventions

Focused Ultrasound OTHER

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

Non-Motor Area Cerebellum; Right Motor Area Cerebellum

Sham OTHER

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

Control

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

MeSH Terms

Interventions

salicylhydroxamic acid

Study Officials

• Wynn Legon, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Adams

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to what group they are assigned to
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: November 19, 2019
• Study Start: January 28, 2019
• Primary Completion: January 27, 2020
• Study Completion: January 27, 2020
• Last Updated: November 19, 2019

Record last verified: 2019-11

Locations

US (1)