Ankylosing Spondylitis, Psoriatic Arthritis, Rheumatoid Arthritis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEUltrasound Stimulation
Ultrasound therapy will be administered to the appropriate target.
DEVICENon-active ultrasound stimulation
Non-active ultrasound therapy will be administered to the appropriate target
Sponsors
Surf Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
22 Years to 75 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Necrosis Factor Alpha Concentration Differences | Baseline to 2 hours post therapy | Measure the change before and after ultrasound stimulation by immunoassay of blood plasma after challenge with LPS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interleuken 1b Concentration Difference | Baseline to 2 hours and 24 hours post therapy | Measure the change before and after ultrasound stimulation by immunoassay of blood plasma after challenge with LPS. |
| Interleuken IL-6 Concentration Difference | Baseline to 2 hours and 24 hours post therapy | Measure the change before and after ultrasound stimulation by immunoassay of blood plasma after challenge with LPS. |
| Tumor Necrosis Factor Alpha Concentration Differences | Baseline to 24 hours post therapy | Measure the change before and after ultrasound stimulation by immunoassay of blood plasma after challenge with LPS. |
Countries
United States
Outcome results
None listed