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Functional Roles of Dorsolateral Prefrontal Cortex

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ClinicalTrials.gov Identifier: NCT03882931
Recruitment Status : Recruiting
First Posted : March 20, 2019
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
University of Virginia

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
Healthy Participants Other: Theta Burst Transcranial Magnetic Stimulation Other: Focused Ultrasound Other: Sham Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 28, 2019
Estimated Primary Completion Date : January 27, 2020
Estimated Study Completion Date : January 27, 2020

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




Primary Outcome Measures :
  1. Performance Error on Visuomotor Task [ Time Frame: immediately following baseline assessment ]
    The visuomotor task has practice, baseline, and experimental trials. Performance on the task will be compared between groups.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03882931


Contacts
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Contact: Sarah Adams 434-243-4319 sa4fa@virginia.edu

Locations
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United States, Virginia
Wynn Legon, PhD Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Sarah Adams    434-243-4319    neuromodlab@hscmail.mcc.virginia.edu   
Sponsors and Collaborators
University of Virginia
Investigators
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Principal Investigator: Wynn Legon, PhD University of Virginia

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Responsible Party: University of Virginia
ClinicalTrials.gov Identifier: NCT03882931     History of Changes
Other Study ID Numbers: 21068
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Virginia:
Dorsolateral Prefrontal Cortex
Neuromodulation
Transcranial Magnetic Stimulation
Transcranial Ultrasound Stimulation