Ultrasound Therapy Effects to Modulate the Inflammatory Reflex
Trial ID or NCT#
NCT05457907
Status
RECRUITING
Purpose
This two treatment group study, including sham treatment, attempts to measure how ultrasound frequency, duration, intensity, and duty cycle impact its acute anti-inflammatory effect in healthy volunteers. It also attempts to contribute to the evidence regarding the comfort and safety of using therapeutic ultrasound. This pilot dose-finding study will be the basis for a larger Phase 2 trial in Rheumatoid Arthritis (RA) patients.
Official Title
Ultrasound Therapy Effects to Modulate the Inflammatory Reflex
Eligibility Criteria
Ages Eligible for Study: 22 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
- - Individuals between 22 and 65 years of age - No physical disabilities or conditions/diseases that limit capacity to participate in study procedures or otherwise increases risk of harm - No significant past medical or surgical histories that would render participants at a greater risk of harm - Sufficient proficiency with the english language to follow verbal instructions during the ultrasound session and to actively participate in the consent process - Able to attend all study visits at approximately the same time of day (i.e., 8 - 12 pm) - Able to comprehend the study goals and procedures, and are able to provide informed consent for participation
Exclusion Criteria:
- - Individuals participating in another research study that may affect the conduct or results of this study - Individuals considered substantially overweight or obese via body mass index (≥ 29) - Individuals having or exhibiting any of the following: - surgery in the past 90 days - previous surgery of the spleen or splenectomy, esophagus, lungs, stomach, duodenum, or liver - recent traumatic injury, including intracerebral hemorrhage and visceral injury - end stage renal disease and/or uremia - active malignancy - previous leukemia and/or lymphoma - human immunodeficiency virus infection or AIDS - rheumatoid arthritis or other immune-mediated diseases (e.g. inflammatory bowel disease) - arrhythmias, including but not limited to, atrial fibrillation, atrial flutter, clinically significant bradycardia, ventricular arrhythmias, and A-V block - implanted pacemaker or cardioverter/defibrillator (AICD) - a history of stable or unstable angina, myocardial infarction, angioplasty or coronary arterial by-pass grafting surgery - history of stroke or transient ischemic attack (TIA) - history of deep venous thrombosis (DVT) and/or pulmonary embolism (PE) - previous episodes of pancreatitis - spinal disorders - chronic pain syndromes - history of thrombosis or bleeding disorders - stage III-IV pressure ulcers - sickle cell anemia or other anemia syndromes - monocytosis - thrombocytopenia - diagnosed with fever of unknown origin (FUO) - previously or currently implanted vagus nerve stimulator - previously or currently implanted spinal cord stimulator - other chronically-implanted electronic medical device - history of diabetes - history of hypertension - history of seizures - history of cancer - Individuals who have taken any of the following medications within one week of receiving ultrasound delivery: - anti-coagulant (Coumadin, Xarelto) - anti-platelet (aspirin, Plavix) - anti-inflammatory (aspirin, NSAIDs) - anti-hypertensive (α-methyldopa) - epinephrine-related drugs, norepinephrine-related drugs, and drugs that stimulate release of epinephrine and/or norepinephrine (Micronefrin, Asthmanefrin) - immunosuppressive agents (steroids, newer immunomodulatory drugs) - alpha and/or beta adrenoceptor blocking agents - anti-seizure medications - other medications, supplements, etc. that may interfere with the ultrasound delivery or study results - Individuals that consumed alcohol within 2 days of the baseline visit - Individuals currently using or have used tobacco or nicotine products within the past 1 month - Pregnant women
Investigator(s)
Robert Michael Fairchild
Rheumatologist
Assistant Professor of Medicine (Immunology and Rheumatology)
Alexander Sackeim
Clinical Assistant Professor, Emergency Medicine
Contact us to find out if this trial is right for you.
Contact
Alexander Sackeim, MD
914-523-7345
View on ClinicalTrials.gov
