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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03863704




Registration number
NCT03863704
Ethics application status
Date submitted
14/02/2019
Date registered
5/03/2019

Titles & IDs
Public title
Transcutaneous VNS to Treat Pediatric IBD
Scientific title
Transcutaneous Vagal Nerve Stimulation to Treat Pediatric Inflammatory Bowel Disease
Secondary ID [1] 0 0
18-0945
Universal Trial Number (UTN)
Trial acronym
STIMIBD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn Disease 0 0
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Transcutaneous Electrical Nerve Stimulation (TENS)

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

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

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.


Treatment: Devices: Transcutaneous Electrical Nerve Stimulation (TENS)
To apply transcutaneous electrical stimulation using a TENS unit to the ear or the leg.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Fecal Calprotectin
Timepoint [1] 0 0
16 weeks
Secondary outcome [1] 0 0
Change in Whole blood stimulated cytokine levels over time
Timepoint [1] 0 0
16 weeks
Secondary outcome [2] 0 0
Patient Reported Outcome (PRO)
Timepoint [2] 0 0
16 weeks
Secondary outcome [3] 0 0
Pediatric Ulcerative colitis activity index (PUCAI)
Timepoint [3] 0 0
16 weeks
Secondary outcome [4] 0 0
Weighted Pediatric Crohn Disease activity index (wPCDAI)
Timepoint [4] 0 0
16 weeks
Secondary outcome [5] 0 0
Physician Global Assessment (PGA) Score
Timepoint [5] 0 0
16 weeks
Secondary outcome [6] 0 0
Heart Rate Variability (HRV)
Timepoint [6] 0 0
16 weeks

Eligibility
Key inclusion criteria
1. Age 10-21 years
2. IBD diagnosis for at least 3 months, confirmed by clinical, biochemical, and endoscopic evaluations
3. Elevated Fecal calprotectin = 200 ug/g within the past 4 weeks prior to enrollment
4. Evidence of active inflammatory disease despite treatment with at least one conventional therapy
5. If on corticosteroids, the dose must be stable and = 10mg/day (prednisone or equivalent) for at least 14 days before entry into study
6. 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
7. 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
8. Able and willing to give written informed consent and comply with the requirements of the study protocol.
Minimum age
10 Years
Maximum age
21 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Expectation to increase corticosteroids and/or immunosuppressive treatment
2. Presence of bowel stricture with prestenotic dilatation
3. Presence of intra-abdominal or perirectal abscess
4. Pediatric UC activity Index (PUCAI) score = 65 (severe)
5. weighted Pediatric Crohn Disease Activity Index (wPCDAI) score > 57.5 (severe)
6. Active treatment with antibiotics
7. Presence of active intestinal infection or documented infection by stool PCR or culture analysis in the previous 6 weeks
8. Continuous treatment with an anti-cholinergic medication, including over the counter medications
9. Implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators.
10. Current tobacco or nicotine user (to limit potential confounding effects of exposure to nicotine)
11. 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
12. Any planned surgical procedure requiring general anesthesia within the course of the study
13. Participation in any other Investigational drug and/or treatment currently or planned during the length of the study
14. Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention
15. Pregnancy or Lactation
16. Comorbid disease with high likelihood of requiring corticosteroid use
17. Inability to comply with study and follow-up procedures
18. Non-English speaking
19. Known cardiac condition causing or with potential to cause arrhythmia

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/02/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2023
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York

Funding & Sponsors
Primary sponsor type
Other
Name
Northwell Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Benjamin Sahn, MD
Address 0 0
Steven & Alexandra Cohen Children's Medical Center - Northwell Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03863704