Cerebellar Functions in Visuomotor Adaptation

November 17, 2019 updated by: University of Virginia

Dissecting Cerebellar Functions in Visuomotor Adaptation With Transcranial Focused Ultrasound Stimulation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to test functions of the cerebellum in human motor learning. The cerebellum has been thought to play critical roles in human motor control and motor learning. Non-invasive brain stimulation studies with transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) provided evidence for the involvement of the cerebellum in human motor learning. However, due to limitations in spatial resolution of tDCS and TMS stimulation, it is still unclear what specific functions the cerebellum may have in motor learning, considering the behavioral and anatomical evidence that the cerebellum also has connections with prefrontal cortex and is associated with cognitive functions. By applying transcranial focused ultrasound stimulation (tFUS), which is a non-invasive brain stimulation technology with great spatial precision, the investigators aim to dissect functions of motor area and non-motor area of the cerebellum in motor learning. Young healthy adults will be recruited and randomly assigned to one of three experimental groups. During learning to adapt to a visual rotation (45 degrees) when reaching for a virtual target, subjects will receive tFUS stimulation over motor area of the cerebellum or non-motor area of the cerebellum depending on the study group. 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.

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Focused Ultrasound
Low intensity focused ultrasound is sound energy stimulation at a low intensity of 1-30 W/cm2
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.
Other: Focused Ultrasound
Low intensity focused ultrasound is sound energy stimulation at a low intensity of 1-30 W/cm2
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.
Other: Sham
The investigators will simulate focused ultrasound stimulation similar to the experimental groups but without stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance Error on Visuomotor Task
Time Frame: baseline, immediately after FUS, and 30 minutes after FUS
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Motor Evoked Potentials (MEP)
Time Frame: baseline, immediately after FUS, 10 minutes after FUS, and 20 minutes after FUS
MEPs will be taken at baseline and throughout the task to assess effects ultrasound stimulation has on MEPs.
baseline, immediately after FUS, 10 minutes after FUS, and 20 minutes after FUS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Wynn Legon, PhD, University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2019

Primary Completion (Anticipated)

January 27, 2020

Study Completion (Anticipated)

January 27, 2020

Study Registration Dates

First Submitted

March 19, 2019

First Submitted That Met QC Criteria

November 17, 2019

First Posted (Actual)

November 19, 2019

Study Record Updates

Last Update Posted (Actual)

November 19, 2019

Last Update Submitted That Met QC Criteria

November 17, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 21135

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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