Ultrasound Effects on Human Motor Cortical Plasticity

NCT04168762 | Unknown

• 1 other identifier: 20620
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Ultrasound; Neuromodulation; Transcranial Magnetic Stimulation; Transcranial Ultrasound Stimulation

Outcome Measures

Primary Outcomes (1)

• Change in Motor Evoked Potential Amplitude

  The effect of ultrasound will be measured by comparing MEP amplitude changes after TUMS compared to baseline. Baseline MEPs will be collected at the beginning of each session and changes in MEP amplitude will be measured directly after with TUMS.

  baseline and immediately following the TUMS stimulation

Study Arms (2)

TUMS and Sham Group

EXPERIMENTAL

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

Other: Transcranial Ultrasound Magnetic Stimulation

TUMS or Sham Group

EXPERIMENTAL

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.

Other: Transcranial Ultrasound Magnetic Stimulation

Interventions

Transcranial Ultrasound Magnetic Stimulation OTHER

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

TUMS and Sham Group; TUMS or Sham Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy, adult subject
• years of age
• Provided 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

Central Study Contacts

Sarah Adams

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be masks from the specific details of the type of TUMS stimulation they are receiving.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized into two groups. Group A will receive a two part Transcranial Ultrasound Magnetic Stimulation (TUMS) on two visits and Group B will receive a one part TUMS on two visits.

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: November 19, 2019
• Study Start: January 28, 2019
• Primary Completion: January 27, 2020
• Study Completion: January 27, 2020
• Last Updated: November 20, 2019

Record last verified: 2019-11

Locations

US (1)