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Behavioural Intervention
tcVNS for Juvenile Arthritis (AJA01 Trial)
Phase 2
Recruiting
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
AJA01 Trial 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.Check my eligibility
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.See study design
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.
AJA01 Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The proportion of participants achieving >= 50 percent improvement in clinical status as defined by JIA ACR 50
Secondary outcome measures
Day 0 as the baseline: The change in Juvenile Disease Activity Score-27 (JADAS-27)
Day 0 as the baseline: The proportion of participants achieving a JIA ACR 30 response
Day 0 as the baseline: The proportion of participants achieving a JIA ACR 50 response
+7 moreAJA01 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.
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Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,270 Previous Clinical Trials
5,485,137 Total Patients Enrolled
Autoimmunity Centers of Excellence (ACE)UNKNOWN
1 Previous Clinical Trials
175 Total Patients Enrolled
Feinstein Institute for Medical Research (FIMR)UNKNOWN
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any more candidates being admitted into this experiment?
"As indicated by clinicaltrials.gov, this medical trial is not currently enrolling patients at this time. The investigation was first announced on April 1st 2023 and had its last update on February 1st 2023; however, there are 372 other trials actively searching for participants presently."
Answered by AI
Is there any way I can be involved in this medical experiment?
"In order to gain admittance to this research project, applicants must have juvenile idiopathic arthritis and be between 5-18 years old. This particular trial has a maximum capacity of 100 participants."
Answered by AI
Is this research endeavor accepting participants who are 25 years of age or older?
"This clinical trial stipulates that the minimum age for inclusion is 5, with a maximum age of 18 in accordance with its criteria."
Answered by AI
Does the FDA recognize Blinded phase as a legitimate protocol?
"The safety rating for Blinded phase is 2, as there exists preliminary evidence indicating its security but not yet any proof of efficacy."
Answered by AI
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