Ultrasound Effects on Human Motor Cortical Plasticity

• Sponsor: University of Virginia (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04168762
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 6.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Other: Transcranial Ultrasound Magnetic Stimulation	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.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.
• Masking: Single (Participant)
• Masking Description: Participants will be masks from the specific details of the type of TUMS stimulation they are receiving.
• Primary Purpose: Basic Science
• Official Title: Ultrasound Effects on Human Motor Cortical Plasticity
• Actual Study Start Date: Jan 28, 2019
• Anticipated Primary Completion Date: Jan 27, 2020
• Anticipated Study Completion Date: Jan 27, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TUMS and Sham Group During the subjects two visits they will receive a TUMS stimulation and a sham (placebo) stimulation at both visits.	Other: Transcranial Ultrasound Magnetic Stimulation; Transcranial Ultrasound Magnetic Stimulation is a paradigm that allows for concurrent and concentric ultrasound stimulation with transcranial magnetic stimulation (TMS).
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.	Other: Transcranial Ultrasound Magnetic Stimulation; Transcranial Ultrasound Magnetic Stimulation is a paradigm that allows for concurrent and concentric ultrasound stimulation with transcranial magnetic stimulation (TMS).

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Virginia	Charlottesville	Virginia	United States	22903

Sponsors and Collaborators

• University of Virginia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Virginia
• ClinicalTrials.gov Identifier: NCT04168762
• Other Study ID Numbers: 20620
• First Posted: Nov 19, 2019
• Last Update Posted: Nov 20, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Virginia: Ultrasound; Neuromodulation; Transcranial Magnetic Stimulation; Transcranial Ultrasound Stimulation

Study Results

No Results Posted as of Nov 20, 2019