Ultrasound Effects on Human Motor Cortical Plasticity

Not Applicable

• Conditions: Healthy Participants
• Interventions: Other: Transcranial Ultrasound Magnetic Stimulation

• Registration Number: NCT04168762
• Lead Sponsor: University of Virginia

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.

Detailed Description

Previous research has shown ultrasound to inhibit motor cortical excitability though it is currently not known how long these effects last. This is an important consideration if ultrasound is to be translated and advanced to clinical or therapeutic uses as this study will help to determine suitable ultrasound durations for efficacious use. The investigators will test the duration of ultrasound neuromodulation using transcranial magnetic stimulation which will elicit a recordable and quantifiable metric of motor cortical excitability in the form of a motor evoked potential.

Participants will complete 3 study visits. During the first study visit, participants will complete Magnetic Resonance Imaging and Computed Tomography scans for TUMS localization in visits 2 and 3. Each participant will undergo motor cortex thresholding prior to their study TUMS stimulation procedure. Depending on randomization, subjects may receive one or two TUMS stimulation procedures at each session.

Study Timeline

• Study Start: 2019-01-28
• Study First Submitted: 2019-02-14
• Status Verified: 2019-11
• Study First Submitted QC: 2019-11-17
• Last Update Submitted: 2019-11-18
• Study First Posted: 2019-11-19
• Last Update Posted: 2019-11-20
• Primary Completion: 2020-01-27
• Study Completion: 2020-01-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TUMS or Sham Group	Transcranial Ultrasound Magnetic Stimulation	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.
TUMS and Sham Group	Transcranial Ultrasound Magnetic Stimulation	During the subjects two visits they will receive a TUMS stimulation and a sham (placebo) stimulation at both visits.

Primary Outcome Measures

Name	Time	Method
Change in Motor Evoked Potential Amplitude	baseline and immediately following the TUMS stimulation	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.

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States