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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 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 |
|
| Control | Sham Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound Stimulation | Device | Ultrasound therapy will be administered to the appropriate target. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Necrosis Factor Alpha Concentration Differences | Measure the change before and after ultrasound stimulation by immunoassay of blood plasma after challenge with LPS. | Baseline to 2 hours post therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Interleuken 1b Concentration Difference | Measure the change before and after ultrasound stimulation by immunoassay of blood plasma after challenge with LPS. | Baseline to 2 hours and 24 hours post therapy |
| Interleuken IL-6 Concentration Difference |
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Healthy Volunteer Population
Inclusion Criteria:
Exclusion Criteria:
Inflammatory Arthritis Population
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tekton Research | Austin | Texas | 78745 | United States | ||
| UT Health |
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| Non-active ultrasound stimulation | Device | Non-active ultrasound therapy will be administered to the appropriate target |
|
Measure the change before and after ultrasound stimulation by immunoassay of blood plasma after challenge with LPS.
| 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. | Baseline to 24 hours post therapy |
| Houston |
| Texas |
| 77030 |
| United States |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| D001172 | Arthritis, Rheumatoid |
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000089183 | Axial Spondyloarthritis |
| D000844 | Ankylosis |
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