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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03882931
Other study ID # 21068
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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 sa4fa@virginia.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Dorsolateral prefrontal cortex (DLPFC) has been found to be involved in cognitive functions such as executive function, response selection, and working memory. By applying transcranial magnetic stimulation (TMS) or transcranial focused ultrasound (FUS), which is a technology to temporally alter brain state in the stimulation site, the investigators aim to find supporting evidence for the causal relationship between the targeted stimulation site and motor learning improvement or response selection.


Description:

The purpose of this study is to test the functions of dorsolateral prefrontal cortex in human motor learning. Dorsolateral prefrontal cortex (DLPFC) has been found to be involved in cognitive functions such as executive function, response selection, and working memory. Recent Findings hint potential involvement of dorsolateral prefrontal cortex in motor learning. Rare studies provided supporting evidence on its involvement and functions. This study aims to examine the functional roles of dorsolateral prefrontal cortex in human motor learning. By applying transcranial magnetic stimulation (TMS) or transcranial focused ultrasound (FUS), which is a technology to temporally alter brain state in the stimulation site, the investigators aim to find supporting evidence for the causal relationship between the targeted stimulation site and motor learning improvement or response selection.

Young healthy adults will be recruited and randomly assigned to one of four experimental groups. If randomized into one of the TMS groups, participants will learn to adapt to two visual rotations (20 and 60 degrees) when reaching for a virtual target, subjects will receive repetitive TMS (rTMS) stimulation over the targeted location, left DLPFC, or right DLPFC depending on the study group. How rTMS stimulation influencing the acquisition and retention of motor memory will be assessed based on group comparison of behavioral measures such as reaching accuracy. If randomized into the FUS group, participants will complete a flanker task to focuses on the assessment of response selection and inhibitory control.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
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

- Have no any type of metal in the body

- Provide written informed consent

Exclusion Criteria:

- Presence of a significant medical, 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

- Failure to follow laboratory or study procedures

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Theta Burst Transcranial Magnetic Stimulation
Theta Bursts are short bursts of stimulation at high frequencies, which are applied 5 times per second
Focused Ultrasound
Low intensity focused ultrasound is sound energy stimulation at a low intensity of 1-30 W/cm2
Sham
The investigators will simulate theta bursts pulses similar to the Theta Burst Transcranial Magnetic Stimulation 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. immediately following baseline assessment
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