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Ultrasound Therapy Effects to Modulate the Inflammatory Reflex
Recruiting
I'm InterestedTrial ID: NCT05457907
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
Stanford Investigator(s)
Robert Michael Fairchild
Assistant Professor of Medicine (Immunology and Rheumatology)
Alexander Sackeim
Clinical Assistant Professor, Emergency Medicine
Eligibility
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
Intervention(s):
device: Ultrasound device
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Alexander Sackeim, MD
914-523-7345