NCT05685108 · University of Virginia
Optimizing Ultrasound-induced Anti-inflammation in Human Subjects
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Charlottesville, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 22, 2025 · Source of record for eligibility and locations