Functional Roles of Dorsolateral Prefrontal Cortex
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 28, 2019
CompletedFirst Submitted
Initial submission to the registry
March 19, 2019
CompletedFirst Posted
Study publicly available on registry
March 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 27, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 27, 2020
CompletedNovember 19, 2019
November 1, 2019
12 months
March 19, 2019
November 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
TMS to left DLPFC
EXPERIMENTALTheta Burst Transcranial Magnetic Stimulation will be delivered at 80% of the participants motor threshold to the left DLPFC and complete a visuomotor rotation task.
TMS to right DLPFC
EXPERIMENTALTheta Burst Transcranial Magnetic Stimulation will be delivered at 80% of the participants motor threshold to the right DLPFC and complete a visuomotor rotation task.
TMS Control
SHAM COMPARATORA Sham Theta Burst Transcranial Magnetic Stimulation will be delivered to the right/left DLPFC and complete a visuomotor rotation task.
FUS to right/left DLPFC
EXPERIMENTALLow 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.
Interventions
Theta Bursts are short bursts of stimulation at high frequencies, which are applied 5 times per second
Low intensity focused ultrasound is sound energy stimulation at a low intensity of 1-30 W/cm2
The investigators will simulate theta bursts pulses similar to the Theta Burst Transcranial Magnetic Stimulation groups but without stimulation.
Eligibility Criteria
You may qualify if:
- Healthy, adult subjects
- to 35 years of age
- Right-handed
- Have no any type of metal in the body
- Provide written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Virginia
Charlottesville, Virginia, 22903, United States
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Wynn Legon, PhD
University of Virginia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants receiving ultrasound stimulation will be blinded to the type of ultrasound stimulation they are receiving.
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2019
First Posted
March 20, 2019
Study Start
January 28, 2019
Primary Completion
January 27, 2020
Study Completion
January 27, 2020
Last Updated
November 19, 2019
Record last verified: 2019-11