tcVNS for Juvenile Arthritis (AJA01 Trial)

Palo Alto (17 mi)

Age: < 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Children and teenagers aged 5-18 with Juvenile Idiopathic Arthritis (JIA) can join this trial. They must have at least 3 joints with active arthritis and be on a stable treatment regimen if already receiving JIA therapy. Girls who can have babies must test negative for pregnancy and agree to birth control measures.

Treatment Details

The study tests the safety and effectiveness of tcVNS, which is a non-invasive device that stimulates the vagus nerve to reduce pain and inflammation in JIA patients. Participants will either receive active tcVNS or a sham (fake) version without knowing which one they are getting.

2Treatment groups

Experimental Treatment

Group I: Open-Label phaseExperimental Treatment1 Intervention

Participants will receive 5 minutes of stimulation via the active tcVNS for 8 weeks after a double-blind, sham-controlled 8- week period.

Group II: Blinded phaseExperimental Treatment1 Intervention

Participants will receive 5 minutes of active tcVNS or sham tcVNS daily for 8 weeks.