Ultrasound Effects on Human Motor Cortical Plasticity

Healthy Participants Clinical Trial

Official title:

Ultrasound Effects on Human Motor Cortical Plasticity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04168762
• Other study ID #: 20620
• Status: Recruiting
• Phase: N/A
• Start date: January 28, 2019
• Est. completion date: January 27, 2020

Study information

• Verified date: November 2019
• Source: University of Virginia
• Contact: Sarah Adams
• Phone: 434-243-4319
• Email: neuromodlab[@]hscmail.mcc.virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 27, 2020
• Est. primary completion date: January 27, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

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).

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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