Recruiting

Ultrasound-Induced Anti-Inflammation

Sponsor:

University of Virginia

Code:

NCT05685108

Conditions

Healthy Subjects

Eligibility Criteria

Sex: All

Age: 25 - 50

Healthy Volunteers: Accepted

Interventions

Ultrasound stimulation intensity

Ultrasound stimulation site

Study Details

Brief summary:

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.

Conditions

Healthy Subjects

Study ID

NCT05685108

Start date

Sep 15, 2024

Status verified date

Jul, 2026

Completion date

Oct 1, 2026

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Ultrasound stimulation intensity

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

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.

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. ]
  • Change in concentrations of immune cells and cytokines depending on ultrasound stimulation site [ 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 and Locations

Central contacts

Mark D. Okusa, MD, FASN

+14349242187mdo7y@virginia.edu

Igor A. Shumilin, PhD

+14349249691IAS2N@hscmail.mcc.virginia.edu

Locations

University of Virginia, Division of Nephrology; Center for Immunity, Inflammation & Regenerative Medicine

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Mark D. Okusa, MD, FASN

+14349242187mdo7y@virginia.edu

Igor A. Shumilin, PhD

+14349249691IAS2N@hscmail.mcc.virginia.edu

More Information

Sponsor

University of Virginia

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

  • Cholinergic anti-inflammatory pathway
  • Vagus nerve
  • Cytokines
  • Neuromodulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2026-07-21.