Optimizing Ultrasound-induced Anti-inflammation in Human Subjects

Launched by UNIVERSITY OF VIRGINIA · Jan 6, 2023

Keywords

ClinConnect Summary

This clinical trial, titled "Optimizing Ultrasound-induced Anti-inflammation in Human Subjects," is exploring whether a specific type of ultrasound treatment can help reduce inflammation in healthy individuals. Researchers want to see if stimulating certain nerves in the body with pulsed ultrasound can trigger an immune response that fights inflammation. This study is currently recruiting participants aged 25 to 50 years, as long as they are generally healthy and can understand the study's goals and procedures.

If you decide to participate, you'll undergo ultrasound treatment in a controlled setting. Before you can join, you'll need to meet specific criteria, such as not having any chronic medical conditions (like heart disease or diabetes) and being free from certain medications for a week prior to the ultrasound. It's important to know that there are some restrictions on who can participate, including factors like weight, recent medical history, and current health status. If you're eligible and choose to take part, you'll help researchers understand how ultrasound might be used to improve health outcomes in the future.

Gender

ALL

Eligibility 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.