Recruiting

Ultrasound

Sponsor:

University of Virginia

Code:

NCT04168762

Conditions

Healthy Participants

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Transcranial Ultrasound Magnetic Stimulation

Study Details

Brief summary:

The purpose of this study is to test the duration and effect of single element focused ultrasound to the primary motor cortex on healthy human participants with the use of transcranial focused ultrasound and transcranial magnetic stimulation.

Conditions

Healthy Participants

Study ID

NCT04168762

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 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Healthy, adult subject
  • 18-65 years of age
  • Provided 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

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: TUMS and Sham Group

During the subjects two visits they will receive a TUMS stimulation and a sham (placebo) stimulation at both visits.

experimental: TUMS or Sham Group

During the subjects first of two visits they will receive either a TUMS stimulation or a sham (placebo) stimulation and at the second visit they will receive the other.

Interventions

Transcranial Ultrasound Magnetic Stimulation

Transcranial Ultrasound Magnetic Stimulation is a paradigm that allows for concurrent and concentric ultrasound stimulation with transcranial magnetic stimulation (TMS).

Primary outcome measure

  • Change in Motor Evoked Potential Amplitude [ Time Frame: baseline and immediately following the TUMS stimulation ]

Central Contacts and Locations

Central contacts

Sarah Adams

434-243-4319neuromodlab@hscmail.mcc.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 20, 2019

Last verified

Nov, 2019

Keywords

  • Ultrasound
  • 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 2019-11-20.