Optimizing Ultrasound-induced Anti-inflammation in Human Subjects

Exclusion Criteria21

• 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.