Cerebellar Functions in Visuomotor Adaptation

Healthy Participants Clinical Trial

Official title:

Dissecting Cerebellar Functions in Visuomotor Adaptation With Transcranial Focused Ultrasound Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04168086
• Other study ID #: 21135
• Status: Recruiting
• Phase: N/A
• Start date: January 28, 2019
• Est. completion date: January 27, 2020

Study information

• Verified date: November 2019
• Source: University of Virginia
• Contact: Sarah Adams
• Phone: 434-243-4319
• Email: neuromodlab[@]hscmail.mcc.virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: January 27, 2020
• Est. primary completion date: January 27, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in Motor Evoked Potentials (MEP)	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