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NCT05710640 · ClinicalTrials.gov registry record · Phase 2
Transcutaneous Cervical Vagus Nerve Stimulation (tcVNS) in JIA
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT05710640 is a Phase 2 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 18 participants.
The verdict
NCT05710640, a Phase 2 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
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.
Interventions
- DEVICE Active tcVNS
- DEVICE Sham tcVNS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2023-06-27 |
| Est. Completion | 2025-01-15 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05710640
The ClinicalTrials.gov registry entry for NCT05710640 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Active tcVNS is the first listed.
NCT05710640 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05710640 about?
NCT05710640 is a clinical study titled "Transcutaneous Cervical Vagus Nerve Stimulation (tcVNS) in JIA". 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...
What is the current status of trial NCT05710640?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2023-06-27. Estimated completion is 2025-01-15.
What interventions are being tested in trial NCT05710640?
The interventions under investigation include: Active tcVNS (DEVICE), Sham tcVNS (DEVICE).
Who is sponsoring clinical trial NCT05710640?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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