Cerebellar Functions in Visuomotor Adaptation

NCT ID: NCT04168086

Last Updated: 2019-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-28

Study Completion Date

2020-01-27

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants will be blinded to what group they are assigned to

Study Groups

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Right Motor Area Cerebellum

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

Group Type EXPERIMENTAL

Focused Ultrasound

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Focused Ultrasound

Intervention Type OTHER

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

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.

Group Type SHAM_COMPARATOR

Sham

Intervention Type OTHER

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

Interventions

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Focused Ultrasound

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

Intervention Type OTHER

Sham

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wynn Legon, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

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University of Virginia

Charlottesville, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sarah Adams

Role: CONTACT

434-243-4319

Facility Contacts

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Sarah Adams

Role: primary

434-243-4319

Other Identifiers

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21135

Identifier Type: -

Identifier Source: org_study_id

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