Functional Roles of Dorsolateral Prefrontal Cortex

NCT ID: NCT03882931

Last Updated: 2019-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-28

Study Completion Date

2020-01-27

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Participants receiving ultrasound stimulation will be blinded to the type of ultrasound stimulation they are receiving.

Study Groups

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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.

Group Type EXPERIMENTAL

Theta Burst Transcranial Magnetic Stimulation

Intervention Type OTHER

Theta Bursts are short bursts of stimulation at high frequencies, which are applied 5 times per second

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.

Group Type EXPERIMENTAL

Theta Burst Transcranial Magnetic Stimulation

Intervention Type OTHER

Theta Bursts are short bursts of stimulation at high frequencies, which are applied 5 times per second

TMS Control

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

Group Type SHAM_COMPARATOR

Sham

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Focused Ultrasound

Intervention Type OTHER

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

Interventions

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Theta Burst Transcranial Magnetic Stimulation

Theta Bursts are short bursts of stimulation at high frequencies, which are applied 5 times per second

Intervention Type OTHER

Focused Ultrasound

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

Intervention Type OTHER

Sham

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wynn Legon, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

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University of Virginia

Charlottesville, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sarah Adams

Role: CONTACT

434-243-4319

Facility Contacts

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Sarah Adams

Role: primary

434-243-4319

Other Identifiers

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21068

Identifier Type: -

Identifier Source: org_study_id

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