Functional Roles of Dorsolateral Prefrontal Cortex

Sponsor
University of Virginia (Other)
Overall Status
Unknown status
CT.gov ID
NCT03882931
Collaborator
(none)
90
1
4
12
7.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Theta Burst Transcranial Magnetic Stimulation
  • Other: Focused Ultrasound
  • Other: Sham
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Participants receiving ultrasound stimulation will be blinded to the type of ultrasound stimulation they are receiving.
Primary Purpose:
Basic Science
Official Title:
Functional Roles of Dorsolateral Prefrontal Cortex in Visuomotor Adaptation and Response Selection
Actual Study Start Date :
Jan 28, 2019
Anticipated Primary Completion Date :
Jan 27, 2020
Anticipated Study Completion Date :
Jan 27, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: TMS to left DLPFC

Theta Burst Transcranial Magnetic Stimulation will be delivered at 80% of the participants motor threshold to the left DLPFC and complete a visuomotor rotation task.

Other: Theta Burst Transcranial Magnetic Stimulation
Theta Bursts are short bursts of stimulation at high frequencies, which are applied 5 times per second

Experimental: TMS to right DLPFC

Theta Burst Transcranial Magnetic Stimulation will be delivered at 80% of the participants motor threshold to the right DLPFC and complete a visuomotor rotation task.

Other: Theta Burst Transcranial Magnetic Stimulation
Theta Bursts are short bursts of stimulation at high frequencies, which are applied 5 times per second

Sham Comparator: TMS Control

A Sham Theta Burst Transcranial Magnetic Stimulation will be delivered to the right/left DLPFC and complete a visuomotor rotation task.

Other: Sham
The investigators will simulate theta bursts pulses similar to the Theta Burst Transcranial Magnetic Stimulation groups but without stimulation.

Experimental: FUS to right/left DLPFC

Low intensity Focused Ultrasound stimulation will be delivered to either the left or right DLPFC depending on the subject's DLPFC response during their functional MRI flanker task.

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

Outcome Measures

Primary Outcome Measures

  1. Performance Error on Visuomotor Task [immediately following baseline assessment]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Virginia Charlottesville Virginia United States 22903

Sponsors and Collaborators

  • University of Virginia

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Virginia
ClinicalTrials.gov Identifier:
NCT03882931
Other Study ID Numbers:
  • 21068
First Posted:
Mar 20, 2019
Last Update Posted:
Nov 19, 2019
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Virginia

Study Results

No Results Posted as of Nov 19, 2019