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Behavioural Intervention
tcVNS for Juvenile Arthritis (AJA01 Trial)
Phase 2
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at weeks 4, 8, 12, and 16
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a device that sends mild electric pulses through the skin to your head/neck to reduce pain/inflammation in Juvenile Idiopathic Arthritis. The device has been cleared by the FDA.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
tcVNS may cause discomfort where it's applied, headache, voice changes due to larynx stimulation, or short-term changes in heart rate or blood pressure. These side effects are generally mild.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at weeks 4, 8, 12, and 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at weeks 4, 8, 12, and 16
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The proportion of participants achieving >= 50 percent improvement in clinical status as defined by JIA ACR 50
Secondary study objectives
Day 0 as the baseline: The change in Juvenile Disease Activity Score-27 (JADAS-27)
Longitudinal trends in Juvenile Arthritis Disease Activity Score-27 (JADAS-27)
Week 8 as the baseline: The change in Juvenile Disease Activity Score-27 (JADAS-27)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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.
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,330 Previous Clinical Trials
5,366,732 Total Patients Enrolled
Autoimmunity Centers of Excellence (ACE)UNKNOWN
1 Previous Clinical Trials
123 Total Patients Enrolled
Feinstein Institute for Medical Research (FIMR)UNKNOWN
Beth GottliebStudy ChairFeinstein Institutes for Medical Research, Cohen Children's Medical Center: Pediatric Rheumatology
Cynthia Aranow, MDStudy ChairFeinstein Institutes for Medical Research
5 Previous Clinical Trials
167 Total Patients Enrolled
Timir Datta-Chaudhuri, PhDStudy ChairFeinstein Institutes for Medical Research
Betty Diamond, MDStudy ChairFeinstein Institutes for Medical Research
5 Previous Clinical Trials
451 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a serious infection in the last 2 weeks.I have been treated with corticosteroids for another illness in the past year.I have a history of irregular heartbeats.I have not had a live vaccine in the last 28 days and won't get one during the study.I have taken high-dose steroids in the last 28 days.I have been diagnosed with POTS.I have tried more than 2 treatments for JIA without success, excluding NSAIDs or joint injections.I have been treated with rituximab within the required time frame.I have been diagnosed with a specific type of Juvenile Idiopathic Arthritis.I have been on long-term medication for muscle spasms or bladder issues.I am between 5 and 18 years old.My guardian can consent and follow the study rules for me as I am 5-6 years old.I am 18 or older and can follow the study's rules.I am of child-bearing age and my pregnancy test was negative.I have had a cortisone injection into a joint within the last 28 days.I have active arthritis in 3 or more joints.I am between 7-17 years old, can follow the study rules, and my guardian agrees.I've had an active illness with specific lab results in the last 3 months.My current treatment for juvenile arthritis is stable and will not change during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Blinded phase
- Group 2: Open-Label phase
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.