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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
16
Ultrasound therapy will be administered to the appropriate target.
Non-active ultrasound therapy will be administered to the appropriate target
Tekton Research
Austin, Texas, United States
UT Health
Houston, Texas, United States
Tumor Necrosis Factor Alpha Concentration Differences
Measure the change before and after ultrasound stimulation by immunoassay of blood plasma after challenge with LPS.
Time frame: Baseline to 2 hours post therapy
Interleuken 1b Concentration Difference
Measure the change before and after ultrasound stimulation by immunoassay of blood plasma after challenge with LPS.
Time frame: Baseline to 2 hours and 24 hours post therapy
Interleuken IL-6 Concentration Difference
Measure the change before and after ultrasound stimulation by immunoassay of blood plasma after challenge with LPS.
Time frame: Baseline to 2 hours and 24 hours post therapy
Tumor Necrosis Factor Alpha Concentration Differences
Measure the change before and after ultrasound stimulation by immunoassay of blood plasma after challenge with LPS.
Time frame: Baseline to 24 hours post therapy
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