Healthy Participants
Conditions
Keywords
Ultrasound, Neuromodulation, Transcranial Magnetic Stimulation, Transcranial Ultrasound Stimulation
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.
Interventions
OTHERTranscranial Ultrasound Magnetic Stimulation
Transcranial Ultrasound Magnetic Stimulation is a paradigm that allows for concurrent and concentric ultrasound stimulation with transcranial magnetic stimulation (TMS).
Sponsors
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Masking description
Participants will be masks from the specific details of the type of TUMS stimulation they are receiving.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactSarah Adams
Outcome results
None listed