Clinical Trials Logo

Clinical Trial Summary

The study is a multicenter, double-blind, sham-controlled trial to evaluate the safety and effectiveness of tcVNS on pain and inflammation associated with JIA. tcVNS is administered with a device that gives off mild electrical impulses through the skin to stimulate the vagus nerve. Part of the vagus nerve and its branches are located in the head and neck. For this study, the impulses will be administered in areas overlying the vagus nerve using a small electrode. The electrode helps to conduct the stimulation through the skin. This stimulation triggers a chemical response through the nerves and has been found to be effective in reducing pain and inflammation in several diseases. The primary objective of this study is to determine the effect of tcVNS on JIA ACR 50 in participants with active JIA. The components of the active and sham tcVNS devices, utilizing the Roscoe Medical TENS 7000, have been FDA 510(k)-cleared and have been determined by the IRB to be a nonsignificant risk device.


Clinical Trial Description

AJA01 is a multicenter, double-blind, sham-controlled, 16-week trial to evaluate the safety and effectiveness of tcVNS for the treatment of JIA. A total of 100 participants will be randomized 1:1 to treatment with active tcVNS or sham tcVNS for 5 minutes once a day for 8 weeks. During this time, participants/parents, and participant assessors will be blinded to treatment assignment; treatments on clinic visit days will be conducted in the clinic under the supervision of a trained, unblinded staff member, and participants will only discuss the stimulation procedure with this staff member. An unblinded site investigator will follow up on any safety events. The double-blind, sham-controlled 8-week period will be followed by an 8-week open-label period in which all participants will receive treatment with active tcVNS once a day for 5 minutes. Participants and their parents will be told it is likely they will feel the stimulation, but it should not be painful. There are 10 visits for the study, 8 clinic visits and 2 tele-visits. Participants will have physical exams with joint assessments, lab tests, and questionnaire completion by the physicians and participants at each clinic visit. Participants will be trained by the unblinded coordinator to perform stimulation during the clinic visit following the randomization. Participants will perform the stimulation at home for 5 minutes daily. Participants will complete a diary to document the daily stimulation. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05710640
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Recruiting
Phase Phase 2
Start date June 27, 2023
Completion date August 1, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT05534347 - Angiogenic Biomarkers in Juvenile Idiopathic Arthritis
Active, not recruiting NCT03725007 - A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis Phase 1
Recruiting NCT03245801 - CAPRI National Juvenile Idiopathic Arthritis Registry
Completed NCT05000216 - COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders Phase 2
Completed NCT01544114 - A Safety Study of VIMOVO in Adolescents With Juvenile Idiopathic Arthritis (JIA) Phase 4