Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) Study in Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

Investigating the Safety and Efficacy of Respiratory-Gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) in Ulcerative Colitis (UC) in Pediatric and Young Adult Populations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05662059
• Other study ID #: IBD-01
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2023
• Source: Cala Health, Inc.
• Contact: Jillian Charyn
• Phone: 516-472-3691
• Email: jcharyn[@]northwell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, single-center, sham-controlled, double-blinded 12-week study designed to evaluate the safety and efficacy of the RAVANS device in subjects with Ulcerative Colitis. The goal of the study is to distinguish sham (no stimulation) versus treatment (stimulation) response and to identify treatment responders. The study will last 12 weeks with in-clinic visits at 0 weeks and 12 weeks, and a telehealth-visit at week 6. Additionally, unscheduled visits may occur based on the needs of the subject or at the discretion of the investigator. Subjects will be randomized 2:1 to treatment or sham, and will stimulate at home twice per day.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 39 Years

Eligibility

Inclusion Criteria:

1. Age 10-39 years

2. UC diagnosis for at least 3 months, confirmed by standard diagnostic evaluations including clinical, biochemical, and endoscopic studies

3. If age 17 years or younger, a PUCAI score of 10-60

4. A partial Mayo score of 3-6

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

• 28 days on or 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, tofacitinib, upadacitinib, ozanimod

8. Able and willing to give written informed consent and comply with the requirements of the study protocol.

9. The earbud electrode must fit properly in the prospective subject's left ear

10. Fecal calprotectin of =150 during screening period

Exclusion Criteria:

1. Expectation to increase corticosteroids and/or immunosuppressive treatment

2. Presence of bowel stricture

3. History of intra-abdominal or perirectal abscess

4. Disease limited to only rectum (ulcerative proctitis)

5. Active treatment with antibiotics

6. Presence of active intestinal infection or documented infection by stool PCR or culture analysis in the previous 6 weeks

7. Continuous treatment with an anticholinergic medication, including over the counter medications (See appendix)

8. Implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators.

9. Current tobacco or nicotine user including nicotine patches, gum and vaping (to limit potential confounding effects of exposure to nicotine)

10. Bowel resection surgery within past 90 days prior to study enrollment, or planned surgery within the course of the study

11. Any planned surgical procedure requiring general anesthesia within the course of the study

12. Participation in any other Investigational drug and/or treatment currently or planned during the length of the study

13. Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention

14. Pregnancy or Lactation

15. Comorbid disease with high likelihood of requiring corticosteroid use

16. Inability to comply with study and follow-up procedures

17. Individuals with prior medical history of significant arrhythmias, including but not limited to, atrial fibrillation, atrial flutter, sick sinus syndrome, and AV blocks

18. Individuals with existing skin lesions on the left ear

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Device:
• RAVANS
Respiratory-Gated Auricular Vagal Afferent Nerve Stimulation
• RAVANS-sham
RAVANS sham device

Locations

Country	Name	City	State
United States	Feinstein Institute for Medical Research at Northwell Health	Lake Success	New York

Sponsors (1)

Lead Sponsor	Collaborator
Cala Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Remission	Remission rate in treatment vs sham, assessed by a 0 or 1 point score in the Partial Mayo at week 12	12 weeks
Secondary	Clinical Responder	Responder rate in treatment vs sham, assessed by greater than or equal to a 2 point reduction in the Partial Mayo score at week 12	12 weeks