tcVNS for Juvenile Arthritis

(AJA01 Trial)

Recruiting at 12 trial locations

Age: < 65

Sex: Any

Trial Phase: Phase 2

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

Must not be taking: Anticholinergics, Rituximab

Disqualifiers: Arrhythmia, POTS, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 16

18 Participants Needed

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.

Research Team

Betty Diamond, MD

Principal Investigator

Northwell Health

Timir Datta-Chaudhuri, PhD

Principal Investigator

Northwell Health

Beth Gottlieb

Principal Investigator

Feinstein Institutes for Medical Research, Cohen Children's Medical Center: Pediatric Rheumatology

Cynthia Aranow, MD

Principal Investigator

Northwell Health

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.

Inclusion Criteria

I have been diagnosed with a specific type of Juvenile Idiopathic Arthritis.

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.

Exclusion 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.

Participant has used cutaneous vagus nerve stimulation within 12 weeks prior to screening

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Blinded Treatment

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

8 weeks

8 clinic visits, 2 tele-visits

Open-Label Treatment

Participants receive 5 minutes of stimulation via the active tcVNS daily for 8 weeks

8 weeks

8 clinic visits, 2 tele-visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Transcutaneous Vagus Nerve Stimulation (tcVNS)

Trial Overview 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.

Participant Groups

Group I: Open-Label phase Experimental Treatment 1 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 phase Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Northwell Health

Collaborator

Trials

481

Recruited

470,000+

Autoimmunity Centers of Excellence (ACE)

Collaborator

Trials

2

Recruited

140+

Feinstein Institute for Medical Research (FIMR)

Collaborator

Trials

1

Recruited

20+