Recruiting

Observational Study

Sponsor:

University of Virginia

Code:

NCT03882931

Conditions

Healthy Participants

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

Theta Burst Transcranial Magnetic Stimulation

Focused Ultrasound

Sham

Study Details

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.

Conditions

Healthy Participants

Study ID

NCT03882931

Start date

Jan 28, 2019

Status verified date

Nov, 2019

Completion date

Jan 27, 2020

Anticipated

Primary completion date

Jan 27, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

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 Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

Interventions

Theta Burst Transcranial Magnetic Stimulation

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

Focused Ultrasound

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

Sham

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

Primary outcome measure

  • Performance Error on Visuomotor Task [ Time Frame: immediately following baseline assessment ]

Central Contacts and Locations

Central contacts

Sarah Adams

434-243-4319sa4fa@virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Sarah Adams

434-243-4319neuromodlab@hscmail.mcc.virginia.edu

More Information

Sponsor

University of Virginia

Last update posted

Nov 19, 2019

Last verified

Nov, 2019

Keywords

  • Dorsolateral Prefrontal Cortex
  • Neuromodulation
  • Transcranial Magnetic Stimulation
  • Transcranial Ultrasound Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2019-11-19.