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Ultrasound for Anti-Inflammation in Healthy Adults

This study is looking at whether using pulsed ultrasound on certain nerves can help reduce inflammation in healthy people. Researchers will place an ultrasound device on your abdomen or neck to stimulate either the splenic nerve or the cervical vagus nerve. They want to see if different levels of ultrasound intensity or different stimulation locations can change the levels of immune cells and other substances (cytokines) in your body that are involved in inflammation. This is a small study aiming to enroll 40 healthy adults between 25 and 50 years old. The goal is to find out which ultrasound methods might be best for controlling inflammation.

Study design
This is an interventional study with 40 healthy participants. It is testing different ultrasound intensities and locations.
What's involved
Immune cells will be assessed before and within 24 to 48 hours after the ultrasound treatment. You will need to be available for the duration of the study.
Compensation
Not stated in the trial record.
Follow-up
Immune cells and cytokines will be measured within 24 to 48 hours after the ultrasound treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05685108

Optimizing Ultrasound-induced Anti-inflammation in Human Subjects

Recruiting
NAAges 25–50InterventionalBasic science
University of Virginia
~40 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:Ultrasound stimulation intensityUltrasound stimulation site

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in concentrations of immune cells and cytokines depending on ultrasound stimulation intensity
Measured over 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.
+1 more outcome measured

Conditions

Healthy Subjects

Explore related trials

Healthy Subjects

Where it's being run

1 sites across 1 states
Virginia1

Study leadership

  • Mark D. Okusa, MD, FASN · PRINCIPAL_INVESTIGATOR · University of Virginia

Who to contact

Mark D. Okusa, MD, FASN
[email protected]
+14349242187
Email the study team

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Eligibility criteria

Inclusion

Male or female, aged 25-50 years
Provision of signed and dated informed consent form
Able to comprehend the study goals and procedures, stated willingness to comply with all study procedures, and availability for the duration of the study
Considered English proficient so that the subject can follow verbal commands during the ultrasound procedure
In good general health, as evidenced by medical history
Laboratory results indicating normal blood count and adequate organ function
Agreement to adhere to Lifestyle Considerations throughout study duration.

Exclusion

Chronic medical conditions, including cancer (in remission or active cancer), cerebrovascular disease, chronic kidney disease, heart conditions (such as heart failure, coronary artery disease, cardiomyopathies), lung disease, liver disease, hypertension, diabetes mellitus type 1 and 2, human immunodeficiency virus infection, primary immunodeficiencies, solid organ or hematopoietic cell transplantation, tuberculosis, and cystic fibrosis, autoimmune disorders (e.g., rheumatoid arthritis, inflammatory bowel disease), sickle cell anemia or other anemia syndromes
Mean systolic and diastolic blood pressure values during screening of ≥160 and ≥100 mm Hg, respectively, hypertension on non-selective beta-blockers and/or alpha-methyl dopa, or hypertension requiring more than two anti-hypertension medications
Obesity (body mass index ≥30 kg/m2)
Use of anti-inflammatory or immunomodulatory medication, such as non- steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or other immunosuppressants, within one week of receiving ultrasound delivery
Use of anticoagulant drugs (e.g., coumadin, direct oral anticoagulants) or antiplatelet drugs (e.g., aspirin, clopidogrel) within one week of receiving ultrasound delivery
Pregnancy, breastfeeding, or planning to become pregnant during the study
Active bacterial or viral infection; febrile illness within 2 weeks of receiving ultrasound delivery
Known allergic reactions to ultrasound gel
Treatment with another investigational drug or other intervention within 1 month of receiving ultrasound delivery
Any vaccination received within 1 month of receiving ultrasound delivery
Current smoker or nicotine use within 2 weeks of receiving ultrasound delivery
Use of recreational drugs within 2 weeks of receiving ultrasound delivery
History of arrythmia (e.g., clinically significant bradycardia, atrial flutter, atrial fibrillation, ventricular arrythmias)
History of deep vein thrombosis or pulmonary embolism
History of bleeding disorder
History of seizure
History of unilateral or bilateral vagotomy
Participants with an implantable medical device, such as pacemaker, hearing aid implant, or any implanted electronic device
Surgery or traumatic injury (e.g., visceral injury, cerebral injury) in the past 3 months
Prior surgery on thyroid or parathyroid glands, esophagus, stomach, or spleen
Participant is considered by the Investigator, after reviewing medical and psychiatric history, physical examination, and laboratory evaluations, to be unsuitable for any other reason that may either place the patient at increased risk during participation or interfere with the interpretation of the study. outcomes.

What this trial measures

  • Change in concentrations of immune cells and cytokines depending on ultrasound stimulation intensityImmune 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.

    The primary outcome is to determine ultrasound intensities that have a biological effect on immune cells measured as a statistically significant change in the level of cytokines produced by immune cells. White blood cells will be isolated from peripheral blood and treated ex vivo with inflammatory stimuli to evaluate their capacity for cytokine production. The cytokines to be measured are (all will be measured in pg/ml): sCD40L; EGF; Eotaxin; FGF-2; FLT-3L; Fractalkine; G-CSF; GM-CSF; GRO; IFNα2; IFNy; IL-1α; IL-1β; IL-1Ra; IL-2; IL-3; IL-4; IL-5; IL-6; IL-7; IL-8; IL-9; IL-10; IL-12p40; IL-12p70; IL-13; IL-15; IL-17A; IL-17E; IL-17F; IL-18; IL-22; IL-27; IP-10; MCP-1; MCP-3; M-CSF; MDC; MIG; MIP-1α; MIP-1β; PDGF-AA; PDGF-AB/BB; TGFα; TNFα; TNFβ; VEGF-A.

  • Change in concentrations of immune cells and cytokines depending on ultrasound stimulation siteImmune 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.

    The primary outcome is to determine the effects of spleen-targeted versus cervical vagus-targeted ultrasound stimulation on the inflammatory capacity of immune cells. This will be measured by stimulating white blood cells from peripheral blood ex vivo with inflammatory stimuli to evaluate their capacity for cytokine production. The cytokines to be measured are (all will be measured in pg/ml): sCD40L; EGF; Eotaxin; FGF-2; FLT-3L; Fractalkine; G-CSF; GM-CSF; GRO; IFNα2; IFNy; IL-1α; IL-1β; IL-1Ra; IL-2; IL-3; IL-4; IL-5; IL-6; IL-7; IL-8; IL-9; IL-10; IL-12p40; IL-12p70; IL-13; IL-15; IL-17A; IL-17E; IL-17F; IL-18; IL-22; IL-27; IP-10; MCP-1; MCP-3; M-CSF; MDC; MIG; MIP-1α; MIP-1β; PDGF-AA; PDGF-AB/BB; TGFα; TNFα; TNFβ; VEGF-A.