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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 22 Years - 75 Years
Gender All
More 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06555562
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Surf Therapeutics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriatic Arthritis, Rheumatoid Arthritis, Ankylosing Spondylitis
Additional Details

The CAP has demonstrated potential as a treatment for various autoimmune and inflammatory disorders, including inflammatory arthritis (Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis) and Inflammatory Bowel Disease (Ulcerative Colitis and Crohn's Disease). The target populations for this study include healthy volunteers and individuals aged 22-75 years diagnosed with Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) or Ankylosing Spondylitis (AS) by a board-certified rheumatologist. Up to 20 healthy volunteers and 40 individuals with RA or PsA will be enrolled. After an initial blood draw, participants will receive either active or sham ultrasound during each visit. There will be a total of 5 visits involving ultrasound, with 2 being a sham and 3 being active. The visit in which the sham is administered will be determined according to the Randomization Table. To ensure participant safety, the ultrasound parameters used for the active sessions will not exceed the FDA's limits. After the US is completed, participants should be asked to wait in the clinic for a few hours following the completion of the US intervention, after which they will have a second blood draw. Once the second blood draw is completed, participants may leave and resume their regular diet. Participants will be asked to return after 24 hours of their intervention for their third blood draw.

Arms & Interventions

Arms

Experimental: Treatment

Participants will receive active treatment during the visit. There will be a total of 5 visits involving ultrasound, with 2 being a sham and 3 being active. Patient is blinded to the treatment. The visit in which the sham is administered will be determined according to the Randomization Table

Sham Comparator: Control

Participants will receive a non-active treatment during the visit. There will be a total of 5 visits involving ultrasound, with 2 being a sham and 3 being active. Patient is blinded to the treatment. The visit in which the sham is administered will be determined according to the Randomization Table

Interventions

Device: - Ultrasound Stimulation

Ultrasound therapy will be administered to the appropriate target.

Device: - Non-active ultrasound stimulation

Non-active ultrasound therapy will be administered to the appropriate target

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Tekton Research, Austin, Texas

Status

Completed

Address

Tekton Research

Austin, Texas, 78745

UT Health, Houston, Texas

Status

Recruiting

Address

UT Health

Houston, Texas, 77030

Site Contact

John Reveille, MD

[email protected]

713-486-3100