- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03882931
Functional Roles of Dorsolateral Prefrontal Cortex
Functional Roles of Dorsolateral Prefrontal Cortex in Visuomotor Adaptation and Response Selection
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sarah Adams
- Phone Number: 434-243-4319
- Email: sa4fa@virginia.edu
Study Locations
-
-
Virginia
-
Charlottesville, Virginia, United States, 22903
- Recruiting
- University of Virginia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
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.
|
Low intensity focused ultrasound is sound energy stimulation at a low intensity of 1-30 W/cm2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
immediately following baseline assessment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wynn Legon, PhD, University of Virginia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 21068
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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