Activating the Cholinergic Anti-Inflammatory Pathway in Healthy Volunteers and People With Inflammatory Arthritis
Completed · Not applicable
Conditions studied: Psoriatic Arthritis, Rheumatoid Arthritis, Ankylosing Spondylitis
In brief
This study is designed to investigate whether non-invasive ultrasound (US) that is optimized for stimulation and can elicit an anti-inflammatory response in people with Inflammatory Arthritis as compared to a sham intervention. The primary endpoint is the change in pro-inflammatory cytokines in blood drawn before and after US. Each participant receives 4 experimental US sessions, one of which is randomly assigned to be placebo.
Key facts
- Study ID
- NCT06555562
- Run by
- Surf Therapeutics
- People needed
- 16
- Starts
- 2025-10-01
- Expected to finish
- 2026-01-05
- Last updated by the study team
- 2026-01-07
Who can join
Age: 22 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 22-75 years of age
- Weigh at least 40 kg
You may not qualify if…
- 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
Where it is running
- Tekton Research — Austin, Texas, United States
- UT Health — Houston, Texas, United States
Full record on ClinicalTrials.gov
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