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

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fecal Calprotectin

Secondary study objectives

Change in Whole blood stimulated cytokine levels over time

Heart Rate Variability (HRV)

Patient Reported Outcome (PRO)

+3 more

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

~960