tcVNS for Juvenile Arthritis
(AJA01 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to manage pain and inflammation in children and teens with Juvenile Idiopathic Arthritis (JIA). It uses a device called Transcutaneous Vagus Nerve Stimulation (tcVNS), which sends gentle electrical pulses to stimulate a nerve in the neck, potentially reducing symptoms. Participants will receive either the real stimulation or a placebo version, followed by a period where everyone receives the real treatment. The trial seeks participants with JIA who have at least three active joints and are on stable medication. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important research.
Do I have to stop taking my current medications for the trial?
You don't have to stop taking your current medications, but they need to be stable for a certain period before the trial. For example, oral steroids must be stable for at least 1 week, NSAIDs for 2 weeks, and some other medications like methotrexate for 8 weeks.
What prior data suggests that this device is safe for juvenile arthritis?
Research shows that transcutaneous Vagus Nerve Stimulation (tcVNS) is generally safe and well-tolerated. Studies have found that it usually causes only mild and short-lasting side effects, such as slight skin irritation or a tingling sensation at the application site. Importantly, the FDA has approved the device used in this study, confirming it meets safety standards. This type of nerve stimulation has been safely used for other conditions to help reduce pain and inflammation. While any treatment carries some risk, current evidence suggests that tcVNS is safe for people.12345
Why do researchers think this study treatment might be promising for juvenile arthritis?
Unlike the standard treatments for juvenile arthritis, which often include medications like NSAIDs or biologics, Transcutaneous Vagus Nerve Stimulation (tcVNS) offers a non-drug approach. Researchers are excited about tcVNS because it uses electrical stimulation to target the vagus nerve, which may help reduce inflammation and pain by modulating the body’s immune response. This method is non-invasive and could minimize the side effects associated with long-term medication use. Additionally, tcVNS provides a novel mechanism of action, potentially offering new hope for patients who do not respond well to conventional therapies.
What evidence suggests that this device is effective for juvenile arthritis?
Research has shown that transcutaneous Vagus Nerve Stimulation (tcVNS) can reduce pain and swelling in various diseases. Studies have found tcVNS effective in easing pain and fatigue in people with systemic lupus erythematosus (SLE). It also lowered inflammation in individuals with rheumatoid arthritis who did not improve with regular treatments. These findings suggest that tcVNS might help those with juvenile idiopathic arthritis (JIA) by reducing pain and swelling. In this trial, participants will receive either active tcVNS or sham tcVNS during the blinded phase, followed by active tcVNS in the open-label phase. The treatment sends gentle electrical signals through the skin to stimulate the vagus nerve, triggering a chemical response that helps relieve symptoms.12367
Who Is on the Research Team?
Beth Gottlieb, MD
Principal Investigator
Feinstein Institutes for Medical Research, Cohen Children's Medical Center: Pediatric Rheumatology
Cynthia Aranow, MD
Principal Investigator
Northwell Health
Timir Datta-Chaudhuri, PhD
Principal Investigator
Northwell Health
Betty Diamond, MD
Principal Investigator
Northwell Health
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Blinded Treatment
Participants receive 5 minutes of active tcVNS or sham tcVNS daily for 8 weeks
Open-Label Treatment
Participants receive 5 minutes of stimulation via the active tcVNS daily for 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Transcutaneous Vagus Nerve Stimulation (tcVNS)
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
Northwell Health
Collaborator
Autoimmunity Centers of Excellence (ACE)
Collaborator
Feinstein Institute for Medical Research (FIMR)
Collaborator