Optimizing Ultrasound-induced Anti-inflammation in Human Subjects

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT05685108
Status
Recruiting
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Conditions

  • Healthy Subjects

Eligibility Criteria

Sex
ALL
Age
25 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Ultrasound stimulation intensity — DEVICE
    A clinical ultrasound transducer will be placed against the abdomen or neck of an individual in order to administer insonification to the splenic nerve.
  • Ultrasound stimulation site — DEVICE
    A clinical ultrasound transducer will be placed against the abdomen or neck of an individual in order to administer insonification to the splenic nerve and the cervical vagus nerve.

Study Details

This is a feasibility study to determine whether pulsed ultrasound stimulation targeting the splenic nerve or the cervical vagus nerve can elicit an anti-inflammatory immune response in healthy volunteers.

Key Dates

Start date
Sep 15, 2024
Status verified
Jul 2025
Primary completion
Oct 31, 2025
Completion
Oct 31, 2025

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Group 1
    In Subgroup 1, individuals will receive pulsed ultrasound with a mechanical index of 0.6 and 1.4 delivered to the splenic hilum. In Subgroup 2, individuals will receive pulsed ultrasound with a mechanical index of 1.0 and 1.8 delivered to the splenic hilum. In Subgroup 3, individuals will receive sham treatment and pulsed ultrasound with a mechanical index of 1.4 delivered to the splenic hilum. In all Subgroups, the two doses will be administered in separate visits with min. 14 days between each stimulation.
  • Active Comparator: Group 2
    Individuals will receive pulsed ultrasound with a mechanical index of 1.4 delivered to the splenic hilum and the cervical vagus nerve. The two doses will be administered in separate visits with min. 14 days between each stimulation.

Primary Outcome Measure

Change in concentrations of immune cells and cytokines depending on ultrasound stimulation intensity [ Time Frame: Immune cells will be stimulated and assessed prior to and within 24 to 48 hours post-ultrasound treatment. Results of Luminex analysis of the pre- and post-ultrasound stimulation supernatants will be compared to quantify the impacts of the treatment. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Virginia, Division of Nephrology; Center for Immunity, Inflammation & Regenerative MedicineCharlottesvilleVirginia22903
Mark D. Okusa, MD, FASN
[email protected]
434-924-2187
Igor A. Shumilin, PhD
[email protected]
+14349249691

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By research site
University of Virginia, Division of Nephrology; Center for Immunity, Inflammation & Regenerative Medicine· Charlottesville, VA

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