Using ultrasound to activate the anti-inflammatory response in arthritis patients
Activating the Cholinergic Anti-Inflammatory Pathway With Focused Ultrasound Stimulation in Healthy Volunteers and People With Inflammatory Arthritis
This study is testing whether using ultrasound can help reduce inflammation in people with arthritis and see if it works better than a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 22 Years to 75 Years |
| Sex | All |
| Sponsor | Surf Therapeutics Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, prednisone |
| Locations | 2 sites (Austin, Texas and 1 other locations) |
| Trial ID | NCT06555562 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of non-invasive ultrasound stimulation on inflammatory arthritis by comparing its impact on pro-inflammatory cytokines in blood samples from participants before and after treatment. Participants, including healthy volunteers and individuals diagnosed with Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis, will undergo four ultrasound sessions, with one being a placebo. The study aims to determine whether the ultrasound can effectively elicit an anti-inflammatory response. Safety measures are in place to ensure that ultrasound parameters remain within FDA limits.
Who should consider this trial
Good fit: Ideal candidates include healthy volunteers and individuals aged 22-75 with a diagnosis of Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis.
Not a fit: Patients with physical disabilities, active infections, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel non-invasive treatment option for patients with inflammatory arthritis.
How similar studies have performed: While the cholinergic anti-inflammatory pathway has shown promise in other autoimmune conditions, this specific approach using ultrasound is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Healthy Volunteer Population Inclusion Criteria: * 22-75 years of age * Weigh at least 40 kg Exclusion Criteria: * Any physical disabilities, conditions, or diseases that limit the capacity to participate in study procedures or increase the risk of harm as determined by the study PI * Unable to provide informed consent * Active bacterial or viral infection * Class II obesity with a BMI of 35 or higher * Pregnant women or those trying to become pregnant * Active use of tobacco/nicotine products * History of substance use disorder or active regular use of substances (nicotine, marijuana, cocaine, psychedelics, stimulants, etc.) * Splenomegaly, asplenia, or splenectomy Inflammatory Arthritis Population Inclusion Criteria: * 22-75 years of age * Weigh at least 40 kg * Diagnosis of Rheumatoid Arthritis, Psoriatic Arthritis, or Axial Spondyloarthritis of at least 6 months duration as defined by ACR guidelines * Able to continue the same stable dose of immunomodulatory medication(s) while participating in the study Exclusion Criteria: * Unable to provide informed consent * Took a JAK inhibitor within the last 4 weeks, or likely to start one while participating in this study * Started a conventional synthetic DMARD (csDMARD) within the last 8 weeks or had a change in prescription within the last 4 week * Started a Tumor Necrosis Factor (TNF) inhibitor within the last 5 months or had a change in prescription within the last 3 months * Started any other biologic or targeted synthetic DMARD within the last 3 months, or likely to start one while participating in the study * Started a corticosteroid, had a change in prescription, or on a stable dose = or \> 10 mg of prednisone daily within the last 4 weeks * Regular use of epinephrine like medications (cold, cough, congestion, or sinus medications, bronchodilators, appetite suppressants) * Active use of tobacco/nicotine products * History of substance use disorder or likely use of substances during the study period (marijuana, opioids/heroin, cocaine, psychedelics, methamphetamine, etc.) * Active bacterial or viral infection * Receiving chemotherapy or immunotherapy to treat malignancy * Significant immunodeficiency due to underlying illness * Class II obesity with a BMI of 35 or higher * Pregnant women or those trying to become pregnant * Wound, rash, infection, or traumatic injury over the target area * Vagal nerve injury or vagotomy * Surgery or major traumatic injury in the past 90 days * Chronically-implanted medical devices (i.e. pacemaker, AICD, vagus nerve stimulator, spinal cord stimulator) * Clinically significant cardiovascular disease * CKD Stage 3 or higher * Uncontrolled fibromyalgia or other diffuse pain syndromes
Where this trial is running
Austin, Texas and 1 other locations
- Tekton Research — Austin, Texas, United States (Completed)
- UT Health — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: John Reveille, MD
- Email: John.D.Reveille@uth.tmc.edu
- Phone: 713-486-3100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.