Low-intensity Focused Ultrasound and Autonomic Response

Part of paid clinical trials in Roanoke, Virginia.

Sponsor
Virginia Polytechnic Institute and State University
Study ID
NCT05834829
Status
Enrolling By Invitation

Conditions

  • Autonomic Dysfunction

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Low-intensity focused ultrasound neuromodulation — DEVICE
    ultrasound transducer applying low intensity waveforms to targeted brain regions for neuromodulation.
  • Sham Low-intensity focused ultrasound — DEVICE
    sham application of ultrasound using blocking of the ultrasound waves of the transducer.

Study Details

Studying the effects of Low Intensity Focused Ultrasound (LIFU) to the dorsal posterior insula (dPI) and dorsal anterior cingulate cortex (dACC) on autonomic control using a test to probe the autonomic system. A cold pressor task will be performed pre and post LIFU application. Physiologic recordings will be recorded throughout.

Key Dates

Start date
Feb 22, 2024
Status verified
Jun 2026
Primary completion
Dec 30, 2026
Completion
Dec 30, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: dPI
    LIFU to the dPI
  • Experimental: ACC
    LIFU to the ACC
  • Sham Comparator: Sham
    Sham LIFU application

Primary Outcome Measure

Sympathetic tone response - Heart Rate Variability (HRV) [ Time Frame: through study completion, an average of 1 month ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fralin Biomedical Research Institute at VTCRoanokeVirginia24016-

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Fralin Biomedical Research Institute at VTC· Roanoke, VA

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