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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03863704
The ClinicalTrials.gov registry entry for NCT03863704 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (99% lower). The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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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Read our methodology - how this data is sourced, computed, and verified.
Related
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