Activating the Cholinergic Anti-Inflammatory Pathway With Focused Ultrasound Stimulation in Healthy Volunteers and People With Inflammatory Arthritis

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 75
Healthy Volunteers: t
View:

• 22-75 years of age

• Weigh at least 40 kg

• 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

Locations
United States
Texas
Tekton Research
COMPLETED
Austin
UT Health
RECRUITING
Houston
Contact Information
Primary
John Reveille, MD
John.D.Reveille@uth.tmc.edu
713-486-3100
Backup
Sharvari Kamat, MS
Sharvari.R.Kamat@uth.tmc.edu
713.500.6981
Time Frame
Start Date: 2024-08-15
Estimated Completion Date: 2027-10
Participants
Target number of participants: 20
Treatments
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
Sponsors
Leads: Surf Therapeutics

This content was sourced from clinicaltrials.gov