Pulsed ultrasound to reduce inflammation by targeting the splenic or cervical vagus nerve
Optimizing Ultrasound-induced Anti-inflammation in Human Subjects
This study will try pulsed ultrasound on the spleen or neck vagus nerve in healthy adults aged 25–50 to see if it triggers an anti-inflammatory immune response.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 25 Years to 50 Years |
| Sex | All |
| Sponsor | University of Virginia Academic / other |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT05685108 on ClinicalTrials.gov |
What this trial studies
This is a feasibility study in healthy volunteers that delivers pulsed ultrasonic stimulation to either the splenic nerve region or the cervical vagus nerve in the neck. Four different ultrasound intensity levels will be tested, and each participant will receive two different intensities to identify doses that produce an anti-inflammatory effect. Blood and immune cells will be collected before and after stimulation to measure cytokine and other immune responses ex vivo. The study compares spleen-targeted versus cervical vagus-targeted approaches to determine which protocol, if any, reduces inflammatory signaling.
Who should consider this trial
Good fit: Healthy adults aged 25–50 with normal lab results, no chronic medical conditions, English proficiency, and the ability to give informed consent and follow study procedures are ideal candidates.
Not a fit: People with chronic illnesses, active inflammatory or autoimmune diseases, or those seeking direct therapeutic benefit are unlikely to receive clinical benefit from this feasibility study.
Why it matters
Potential benefit: If successful, the approach could offer a noninvasive way to reduce harmful inflammation without implants or systemic drugs.
How similar studies have performed: Implantable vagus nerve stimulation has shown benefit in some autoimmune conditions and preclinical work supports ultrasound neuromodulation, but human evidence for ultrasound-driven anti-inflammatory effects is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Charlottesville, Virginia
- University of Virginia, Division of Nephrology; Center for Immunity, Inflammation & Regenerative Medicine — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Mark D. Okusa, MD, FASN — University of Virginia
- Study coordinator: Mark D. Okusa, MD, FASN
- Email: mdo7y@virginia.edu
- Phone: +14349242187
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.