Investigation of the Duration of Low-intensity Focused Ultrasound
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low-Intensity Focused Ultrasound.
- Who it may be relevant to
- Registry conditions: Development of LIFU for Clinical Purposes. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
This project examines the effects of various durations of noninvasive neuromodulation on muscle contractions. The investigators believe this study will help to better understand noninvasive brain stimulation techniques that may have the potential to aid in addiction, pain, and mental health issues. Participants undergo structural imaging, a functional Magnetic Resonance Image (fMRI) and computed tomography (CT). These images are used to align the low-intensity focused ultrasound (LIFU) and transcranial magnetic stimulation (TMS) devices to temporarily change brain activity. Electromyography (EMG) will be used to record muscle contractions of the hand.
Interventions
- Device Low-Intensity Focused Ultrasound
LIFU application using various durations, responses of neuromodulation recorded using TMS and EMG.
Primary outcome measures
- Waveforms [Time frame: Outcomes assessed throughout participation - an average of 3 weeks.]
Eligibility criteria
Inclusion criteria
- Above criteria and must understand and speak English.
Exclusion criteria
- Contraindications to MRI, CT, or TMS
- Claustrophobia
- Pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
- Pregnancy
- Active medical disorder or treatment with potential CNS effects
- History of neurologic disorder
- History of head injury resulting in loss of consciousness for >10 minutes
- History of alcohol or drug dependence
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Fralin Biomedical Research Institute — Roanoke
Publications
- Legon W, Bansal P, Tyshynsky R, Ai L, Mueller JK. Transcranial focused ultrasound neuromodulation of the human primary motor cortex. Sci Rep. 2018 Jul 3;8(1):10007. doi: 10.1038/s41598-018-28320-1. PMID 29968768
- Legon W, Ai L, Bansal P, Mueller JK. Neuromodulation with single-element transcranial focused ultrasound in human thalamus. Hum Brain Mapp. 2018 May;39(5):1995-2006. doi: 10.1002/hbm.23981. Epub 2018 Jan 29. PMID 29380485
- Legon W, Sato TF, Opitz A, Mueller J, Barbour A, Williams A, Tyler WJ. Transcranial focused ultrasound modulates the activity of primary somatosensory cortex in humans. Nat Neurosci. 2014 Feb;17(2):322-9. doi: 10.1038/nn.3620. Epub 2014 Jan 12. PMID 24413698
Identifiers
NCT: NCT05147103 · 21-892