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Activating the Cholinergic Anti-Inflammatory Pathway in Healthy Volunteers and People With Inflammatory Arthritis

CompletedNA

Sponsor: Surf Therapeutics

Conditions: Psoriatic Arthritis, Rheumatoid Arthritis, Ankylosing Spondylitis

Interventions: Ultrasound Stimulation, Non-active ultrasound stimulation

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 22 Years to 75 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility 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

Locations (2)

Austin, Texas, United States
Houston, Texas, United States