Optimizing Ultrasound-induced Anti-inflammation in Human Subjects
ConditionHealthy Subjects
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-50
SponsorUniversity of Virginia
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Ultrasound stimulation intensity
- Ultrasound stimulation site
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov