Sound waves as medicine: ultrasound may tame inflammation without drugs

NCT ID NCT05685108

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This study explores whether brief pulses of ultrasound aimed at the spleen or a nerve in the neck can trigger an anti-inflammatory response. Healthy adults aged 25 to 50 will receive ultrasound through a handheld device placed on the abdomen or neck. Researchers will measure changes in immune cells and inflammatory markers in the blood to see if the technique works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pulsed ultrasound stimulation targeting the splenic nerve or cervical vagus nerve
What this could lead to
If it works, this could point toward a non-drug way to control inflammation, potentially helping people with inflammatory diseases.
What could go wrong
This is a small, early feasibility study in healthy people, so results may not apply to those with illness. The effect may be too weak or inconsistent to be useful.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

25 to 50 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

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How to take part

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Contacts and locations

Locations

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

    RECRUITING

    Charlottesville, Virginia, 22903, United States

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