Transcutaneous Cervical Vagus Nerve Stimulation (tcVNS) in JIA
Public ClinicalTrials.gov record NCT05710640. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Using the Cholinergic Anti-Inflammatory Pathway to Treat Juvenile Idiopathic Arthritis (AJA01)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 using a small electrode at the cymba concha for participants receiving treatment with active tcVNS and at the neck for participants receiving sham stimulation. 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.
Study identification
- NCT ID
- NCT05710640
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 18 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 5 Years to 18 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 26, 2023
- Primary completion
- Nov 12, 2024
- Completion
- Jan 14, 2025
- Last update posted
- Nov 24, 2025
2023 – 2025
United States locations
- U.S. sites
- 7
- U.S. states
- 6
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California San Francisco School of Medicine: Department of Pediatrics, Division of Pediatric Rheumatology | San Francisco | California | 94158 | — |
| Nemours Children's Health: Department of Pediatric Rheumatology | Orlando | Florida | 32827 | — |
| Indiana University Medical Center: Riley Hospital for Children Department of Pediatric Rheumatology | Indianapolis | Indiana | 46202 | — |
| Feinstein Institutes for Medical Research, Cohen Children's Medical Center: Pediatric Rheumatology | Lake Success | New York | 11040 | — |
| Stephen D. Hassenfield Children's Center at NYU Langone Health | New York | New York | 10016 | — |
| Division of Pediatric Rheumatology at the University of Utah School of Medicine and Primary Children's Hospital | Salt Lake City | Utah | 84132 | — |
| Seattle Children's Hospital: Rheumatology Clinic | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05710640, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 24, 2025 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05710640 live on ClinicalTrials.gov.