- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03863704
Transcutaneous VNS to Treat Pediatric IBD (STIMIBD)
March 6, 2023 updated by: Northwell Health
Transcutaneous Vagal Nerve Stimulation to Treat Pediatric Inflammatory Bowel Disease
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New Hyde Park, New York, United States, 11042
- Steven & Alexandra Cohen Children's Medical Center of New York
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 10-21 years
- IBD diagnosis for at least 3 months, confirmed by clinical, biochemical, and endoscopic evaluations
- Elevated Fecal calprotectin ≥ 200 ug/g within the past 4 weeks prior to enrollment
- Evidence of active inflammatory disease despite treatment with at least one conventional therapy
- If on corticosteroids, the dose must be stable and ≤ 10mg/day (prednisone or equivalent) for at least 14 days before entry into study
If on 5-Aminosalicylate, dose must be stable with following parameters:
- 28 days on oral medication
- Prior to baseline calprotectin, 28 days on rectal medication or 2 weeks off rectal medication
If on background immunosuppressive treatment the dose must be stable with the following parameters:
- 56 days (8 weeks) for Immunomodulators (methotrexate, 6-MP, Azathioprine)
- 112 days (16 weeks) for Infliximab, Adalimumab, Vedolizumab, Ustekinumab, other biologic
- Able and willing to give written informed consent and comply with the requirements of the study protocol.
Exclusion Criteria:
- Expectation to increase corticosteroids and/or immunosuppressive treatment
- Presence of bowel stricture with prestenotic dilatation
- Presence of intra-abdominal or perirectal abscess
- Pediatric UC activity Index (PUCAI) score ≥ 65 (severe)
- weighted Pediatric Crohn Disease Activity Index (wPCDAI) score > 57.5 (severe)
- Active treatment with antibiotics
- Presence of active intestinal infection or documented infection by stool PCR or culture analysis in the previous 6 weeks
- Continuous treatment with an anti-cholinergic medication, including over the counter medications
- Implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators.
- Current tobacco or nicotine user (to limit potential confounding effects of exposure to nicotine)
- Bowel resection surgery within past 90 days prior to study enrollment and on no conventional IBD therapy, or planned surgery within the course of the study
- Any planned surgical procedure requiring general anesthesia within the course of the study
- Participation in any other Investigational drug and/or treatment currently or planned during the length of the study
- Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention
- Pregnancy or Lactation
- Comorbid disease with high likelihood of requiring corticosteroid use
- Inability to comply with study and follow-up procedures
- Non-English speaking
- Known cardiac condition causing or with potential to cause arrhythmia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: nerve stimulation ear then leg
Subjects in this arm will be randomized to receive nerve stimulation with TENS of the ear followed by leg stimulation
|
To apply transcutaneous electrical stimulation using a TENS unit to the ear or the leg.
|
Sham Comparator: nerve stimulation leg then ear
Subjects in this arm will be randomized to receive leg nerve stimulation with TENS followed by ear nerve stimulation
|
To apply transcutaneous electrical stimulation using a TENS unit to the ear or the leg.
|
Other: Subjects receiving Infliximab
Subjects on Infliximab as part of their clinical care will not be randomized as the study treatment for these subjects will be the same.
The sham arm is not included for patients on infliximab.
|
To apply transcutaneous electrical stimulation using a TENS unit to the ear or the leg.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fecal Calprotectin
Time Frame: 16 weeks
|
Change in fecal calprotectin over time
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Whole blood stimulated cytokine levels over time
Time Frame: 16 weeks
|
Blood will be collected into 2 tubes, one with no stimulant and the other with lipopolysaccharide (LPS) to stimulate macrophages to produce cytokines.
Cytokine levels within the blood will be assessed and compared to baseline levels.
The cytokines being assayed include tumor necrosis factor-alpha, Interferon-gamma, Transforming Growth Factor-beta and Interleukins (IL) - 1, 6, 10, 12, 17, 18, 23.
Samples will be collected for this analysis at week 0, 2, 4, and 24
|
16 weeks
|
Patient Reported Outcome (PRO)
Time Frame: 16 weeks
|
PROMIS Pediatric Profile v2.0-25 and PROMIS Parent Proxy v2.0- 25 questionnaires to evaluate the effect of VNS on abdominal pain intensity and interference in daily activities, fatigue, anxiety, depression, physical function and peer relationships
|
16 weeks
|
Pediatric Ulcerative colitis activity index (PUCAI)
Time Frame: 16 weeks
|
Change in Pediatric ulcerative colitis activity index over time
|
16 weeks
|
Weighted Pediatric Crohn Disease activity index (wPCDAI)
Time Frame: 16 weeks
|
Change in weighted Pediatric Crohn Disease activity index over time
|
16 weeks
|
Physician Global Assessment (PGA) Score
Time Frame: 16 weeks
|
Change in physician global assessment score over time
|
16 weeks
|
Heart Rate Variability (HRV)
Time Frame: 16 weeks
|
Evaluating change in HRV from baseline until study completion
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Benjamin Sahn, MD, Steven & Alexandra Cohen Children's Medical Center - Northwell Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 14, 2019
Primary Completion (Actual)
December 31, 2022
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
February 14, 2019
First Submitted That Met QC Criteria
March 4, 2019
First Posted (Actual)
March 5, 2019
Study Record Updates
Last Update Posted (Estimate)
March 7, 2023
Last Update Submitted That Met QC Criteria
March 6, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-0945
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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