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Behavioural Intervention
Non-Invasive Nerve Stimulation for Pediatric IBD (STIMIBD Trial)
N/A
Waitlist Available
Led By Benjamin Sahn, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
STIMIBD Trial Summary
This trial will test whether transcutaneous vagal nerve stimulation (a non-invasive nerve stimulation through the skin) can decrease inflammation in people with inflammatory bowel disease, leading to improved signs and symptoms of disease.
Who is the study for?
This trial is for kids and young adults aged 10-21 with Crohn's Disease or Ulcerative Colitis. They must have active inflammation despite treatment, stable medication doses if on corticosteroids or immunosuppressants, and no severe disease activity. Exclusions include recent bowel surgery, certain infections, tobacco use, planned surgeries requiring anesthesia, and those unable to follow the study plan.Check my eligibility
What is being tested?
The trial tests transcutaneous VNS (nerve stimulation through the skin) as a new way to treat IBD in children without surgery. It will check if this can reduce inflammation by looking at changes in fecal calprotectin levels after 16 weeks of treatment along with symptom scores and blood markers.See study design
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site and possible interference with heart rate variability due to nerve stimulation. However, since it's non-invasive there are fewer risks compared to surgical options.
STIMIBD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fecal Calprotectin
Secondary outcome measures
Change in Whole blood stimulated cytokine levels over time
Heart Rate Variability (HRV)
Patient Reported Outcome (PRO)
+3 moreSTIMIBD Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Subjects receiving InfliximabExperimental Treatment1 Intervention
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.
Group II: nerve stimulation ear then legPlacebo Group1 Intervention
Subjects in this arm will be randomized to receive nerve stimulation with TENS of the ear followed by leg stimulation
Group III: nerve stimulation leg then earPlacebo Group1 Intervention
Subjects in this arm will be randomized to receive leg nerve stimulation with TENS followed by ear nerve stimulation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcutaneous Electrical Nerve Stimulation (TENS)
2023
N/A
~680
Find a Location
Who is running the clinical trial?
Northwell HealthLead Sponsor
458 Previous Clinical Trials
470,903 Total Patients Enrolled
Benjamin Sahn, MDPrincipal InvestigatorSteven & Alexandra Cohen Children's Medical Center - Northwell Health
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a narrowing in your intestines with widening before the narrowing.You are currently taking antibiotics for an infection.You are currently taking any medication that affects the cholinergic system, including over-the-counter drugs.You are not currently taking or planning to take any experimental drugs or treatments during the study.You have another medical condition that is likely to require the use of corticosteroids.You have a condition that causes inflammation, and it is not getting better even after trying different treatments.You are expected to take more corticosteroids or other medications that weaken your immune system.You have a heart condition that can cause irregular heartbeats.You have devices in your body like pacemakers, defibrillators, hearing aids, cochlear implants, or deep brain stimulators.
Research Study Groups:
This trial has the following groups:- Group 1: Subjects receiving Infliximab
- Group 2: nerve stimulation ear then leg
- Group 3: nerve stimulation leg then ear
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I eligible to join this research experiment?
"This clinical trial requires a group of 30 patients aged between 10 and 21 years old with ileocolitis. Moreover, those individuals must have been treated with conventional therapies for three months or more; had an elevated Faecal calprotectin level ≥ 200 ug/g in the four weeks before enrollment; necessary medication administered 28 days prior to baseline calprotectin measurements (oral or rectal); 56-112 days on Immunomodulators/Infliximab/Adlumimumab/Vedolizumab etc.; stable dose of corticosteroids ≤ 10mg per day for 14+ days; and be"
Answered by AI
Are there any more openings in this investigation?
"At present, this medical trial is not accepting applications. Originally posted in February 2019 and recently updated on the 1st of February 2022, no new patients are being sought at this time; however, 425 other trials currently remain open to enrollment."
Answered by AI
Is eligibility for this research project restricted to those who are under 20 years of age?
"According to the enrollment requirements of this trial, participants must fall between 10 and 21 years old."
Answered by AI
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