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NCT03863704 · ClinicalTrials.gov registry record · NA
Transcutaneous VNS to Treat Pediatric IBD
A NA study of Ulcerative Colitis and Crohn Disease, sponsored by Northwell Health.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT03863704: Completed NA study of Ulcerative Colitis and Crohn Disease, sponsored by Northwell Health.
NCT03863704 is a NA study of Ulcerative Colitis and Crohn Disease that has completed, run by Northwell Health. The registered enrollment target is 30 participants, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03863704, a NA study of Ulcerative Colitis and Crohn Disease, has completed, sponsored by Northwell Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The current available therapies for inflammatory bowel disease (IBD), including immunomodulator and biologic medications may have toxicities limiting use or inadequate effect. We propose a novel approach to the treatment of IBD by using transcutaneous vagal nerve stimulation (VNS). Research has previously identified that VNS using a surgically implanted stimulator can improve symptoms and decrease inflammation in people with inflammatory diseases. This study will evaluate the use of non-invasive nerve stimulation through the skin (rather than through an implanted device) as a potential therapy in pediatric patients with Crohn Disease or ulcerative colitis. We will be evaluating how this nerve stimulation affects symptoms, markers of inflammation found in the blood and stool including cytokine levels, and heart rate variability. The primary hypothesis of the study is the use of transcutaneous VNS will decrease inflammation in people with IBD leading to improved signs and symptoms of disease. The primary endpoint of the study is to evaluate the change in fecal calprotectin after 16 weeks of nerve stimulation. Secondary endpoints include changes in symptom scores, blood cytokine levels, and heart rate variability.
Primary Outcome
Change in fecal calprotectin over time
Conditions Studied
Interventions
- DEVICE Transcutaneous Electrical Nerve Stimulation (TENS)
Study Locations (1)
New York
- Steven & Alexandra Cohen Children's Medical Center of New York - New Hyde Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-02-14 |
| Est. Completion | 2023-12-31 |
| Phase | NA |
What the finished NCT03863704 record still lists
NCT03863704 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Ulcerative Colitis appearing as the primary indexed condition, and to 1 intervention - of which Transcutaneous Electrical Nerve Stimulation (TENS) is the first listed.
NCT03863704 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03863704 about?
NCT03863704 is a clinical study titled "Transcutaneous VNS to Treat Pediatric IBD". The current available therapies for inflammatory bowel disease (IBD), including immunomodulator and biologic medications may have toxicities limiting use or inadequate effect. We propose a novel approach to the treatment of IBD by using transcutaneous vagal nerve stimulation (VNS). Research has prev...
What is the current status of trial NCT03863704?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2019-02-14. Estimated completion is 2023-12-31.
What conditions does trial NCT03863704 study?
This clinical trial studies the following conditions: Ulcerative Colitis, Crohn Disease.
What interventions are being tested in trial NCT03863704?
The interventions under investigation include: Transcutaneous Electrical Nerve Stimulation (TENS) (DEVICE).
Who is sponsoring clinical trial NCT03863704?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03863704 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03863704's enrollment target sits among peer trials
30 103rd of 122 higher than 18 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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