Ultrasound Effects on Human Motor Cortical Plasticity

University of Virginia

Status: Unknown

Conditions: Healthy Participants

Treatments: Other: Transcranial Ultrasound Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04168762

20620

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

TUMS and Sham Group

Experimental group

Description:

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

Treatment:

Other: Transcranial Ultrasound Magnetic Stimulation

TUMS or Sham Group

Experimental group

Description:

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.

Treatment:

Other: Transcranial Ultrasound Magnetic Stimulation