Actively Recruiting

Phase Not Applicable
Age: 25Years - 50Years
All Genders
Healthy Volunteers
NCT05685108

Optimizing Ultrasound-induced Anti-inflammation in Human Subjects

Led by University of Virginia · Updated on 2025-07-22

40

Participants Needed

1

Research Sites

54 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Optimizing Ultrasound-induced Anti-inflammation in Human Subjects

Who Can Participate

Age: 25Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, aged 25-50 years
  • Signed and dated informed consent form
  • Able to understand the study goals and procedures and willing to follow all study requirements
  • Proficient in English to follow verbal commands during ultrasound
  • In good general health based on medical history
  • Normal blood count and adequate organ function as shown by lab results
  • Agree to follow lifestyle considerations during the study
Not Eligible

You will not qualify if you...

  • Chronic medical conditions such as cancer, cerebrovascular disease, kidney disease, heart disease, lung disease, liver disease, hypertension, diabetes, HIV infection, immunodeficiencies, organ transplantation, tuberculosis, cystic fibrosis, autoimmune disorders, or anemia syndromes
  • High blood pressure with systolic ≥160 mm Hg or diastolic ≥100 mm Hg, or requiring multiple medications
  • Obesity with body mass index ≥30 kg/m2
  • Use of anti-inflammatory, immunomodulatory, anticoagulant, or antiplatelet drugs within one week prior to ultrasound
  • Pregnancy, breastfeeding, or planning pregnancy during study
  • Active infections or fever within two weeks prior to ultrasound
  • Allergies to ultrasound gel
  • Participation in other investigational treatments within one month
  • Recent vaccination within one month
  • Current smoking or nicotine use within two weeks
  • Recreational drug use within two weeks
  • History of arrhythmia, deep vein thrombosis, pulmonary embolism, bleeding disorders, or seizures
  • Prior vagotomy
  • Presence of implantable medical devices like pacemakers or hearing aids
  • Recent surgery or injury within three months
  • Prior surgery on thyroid, parathyroid, esophagus, stomach, or spleen
  • Investigator judgment deeming participant unsuitable for safety or study integrity reasons

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

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

Charlottesville, Virginia, United States, 22903

Actively Recruiting

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Research Team

M

Mark D. Okusa, MD, FASN

CONTACT

I

Igor A. Shumilin, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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