Optimizing Ultrasound-induced Anti-inflammation in Human Subjects

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.

Inclusion Criteria:Male or female, aged 25-50 yearsProvision of signed and dated informed consent formAble to comprehend the study goals and procedures, stated willingness to comply with all study procedures, and availability for the duration of the studyConsidered English proficient so that the subject can follow verbal commands during the ultrasound procedureIn good general health, as evidenced by medical historyLaboratory results indicating normal blood count and adequate organ functionAgreement 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 syndromesMean 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 medicationsObesity (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 deliveryUse of anticoagulant drugs (e.g., coumadin, direct oral anticoagulants) or antiplatelet drugs (e.g., aspirin, clopidogrel) within one week of receiving ultrasound deliveryPregnancy, breastfeeding, or planning to become pregnant during the studyActive bacterial or viral infection; febrile illness within 2 weeks of receiving ultrasound deliveryKnown allergic reactions to ultrasound gelTreatment with another investigational drug or other intervention within 1 month of receiving ultrasound deliveryAny vaccination received within 1 month of receiving ultrasound deliveryCurrent smoker or nicotine use within 2 weeks of receiving ultrasound deliveryUse of recreational drugs within 2 weeks of receiving ultrasound deliveryHistory of arrythmia (e.g., clinically significant bradycardia, atrial flutter, atrial fibrillation, ventricular arrythmias)History of deep vein thrombosis or pulmonary embolismHistory of bleeding disorderHistory of seizureHistory of unilateral or bilateral vagotomyParticipants with an implantable medical device, such as pacemaker, hearing aid implant, or any implanted electronic deviceSurgery or traumatic injury (e.g., visceral injury, cerebral injury) in the past 3 monthsPrior surgery on thyroid or parathyroid glands, esophagus, stomach, or spleenParticipant 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.