Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06555562
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-03
Brief Title:
Activating the Cholinergic Anti-Inflammatory Pathway in Healthy Volunteers and People With Inflammatory Arthritis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Activating the Cholinergic Anti-Inflammatory Pathway With Focused Ultrasound Stimulation in Healthy Volunteers and People With Inflammatory Arthritis
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Crohns 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 4 visits involving ultrasound with 1 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 FDAs 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
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 4 visits involving ultrasound with 1 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 FDAs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None