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

Launched by SURF THERAPEUTICS · Aug 12, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a treatment that uses non-invasive ultrasound to see if it can help reduce inflammation in people with certain types of inflammatory arthritis, like psoriatic arthritis, rheumatoid arthritis, and ankylosing spondylitis. Researchers want to find out if this ultrasound can lower the levels of specific substances in the blood that are linked to inflammation. Participants will undergo four sessions of the ultrasound treatment, with one session being a "placebo," which means it will not deliver the actual treatment but will help the researchers compare results.

To take part in the study, individuals must be between 22 and 75 years old, weigh at least 40 kg, and have been diagnosed with one of the specified types of arthritis for at least six months. They should also be stable on their current medications. However, there are certain exclusions, such as having active infections, using tobacco products, or having recent changes in some medications. Participants can expect to have their blood tested before and after the ultrasound sessions to measure the treatment's effects, and they will be closely monitored throughout the study.

Gender

ALL

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