Non-invasive Vagus Nerve Stimulation in the Treatment of Crohn's Disease - A Pilot Study

NCT05165108 | Terminated Results FDA Device

• 1 other identifier: 10734
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the safety and efficacy of transcutaneous vagal stimulation in adult patients with active Crohn's disease.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• Change in Fecal Calprotectin From Baseline to 16 Weeks

  This test can identify the level of inflammation in the colon of a person with Crohn's Disease. If a person diagnosed with Crohn's Disease subsequently shows low levels (50 -200 ug/mg) of fecal calprotectin, this means that the inflammation is being controlled, so the treatment regime is working.

  Baseline and 16 weeks

Secondary Outcomes (4)

• Change in Crohn's Disease Activity Index (CDAI) From Baseline to 16 Weeks

  Baseline and 16 Weeks

• Change in Serum Cytokine Levels From Baseline to 16 Weeks

  16 Weeks

• Evaluating Change in HRV From Baseline Until Study Completion.

  16 Weeks

• Change in Insulin Levels After First Stimulation

  Baseline Visit

Study Arms (1)

Non-Invasive VNS

EXPERIMENTAL

Non-Invasive VNS will decrease inflammation in people with Crohn's disease leading to decrease in inflammatory markers and symptoms of disease.

Device: Vagal Nerve Stimulator

Interventions

Vagal Nerve Stimulator DEVICE

A handheld device which consists of a battery powered portable stimulator with a digital control user interface that controls signal amplitude and two steel contact electrodes will deliver the nVNS electrical stimulation to the cervical Vagus nerve. The device has been approved by the U.S. Food and Drug Administration (FDA) for non-invasive Vagus nerve stimulator therapy for adjunctive use for the prevention and treatment of migraine and cluster headaches in adult patients.

Also known as: GammaCore nVNS

Non-Invasive VNS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Crohn's disease diagnosis for at least 3 months, confirmed by clinical, biochemical, and endoscopic evaluations.
• Patients with CD involving the small bowel and / or colon with active symptoms with Crohn's Disease Activity Index (CDAI) \> 220 despite at least one conventional therapy (corticosteroids and/or immunosuppressives) with a stable dose will be included.
• Elevated Fecal calprotectin ≥ 200 micro g/g within the past 4 weeks prior to enrollment
• If on corticosteroids, the dose must be stable and ≤ 20mg/day prednisone or equivalent for at least 14 days before entry into study.
• If on background immunosuppressive treatment the dose must be stable with the following parameters:
• days (8 weeks) for Immunomodulators (methotrexate, 6-MP, Azathioprine) and small molecules (upadacitinib)
• days (16 12 weeks) for biologics (Infliximab, Adalimumab, Vedolizumab, Ustekinumab, another biologic Risankizumab)
• Clinical laboratory evaluations (including a chemistry panel, complete blood count \[CBC\], and urinalysis \[UA\]) within the reference range for the test laboratory, unless a typical consequence of CD or deemed not clinically significant by the Investigator.
• Colonoscopy within the previous 1 year with no evidence of colonic dysplasia or cancer.
• Able and willing to give written informed consent and comply with the requirements of the study protocol.

You may not qualify if:

• Expectation to increase corticosteroids and/or immunosuppressive treatment
• Presence of bowel stricture with pre-stenotic dilatation
• Presence of intra-abdominal or perirectal abscess
• Crohn's Disease Activity Index (CDAI) \< 220
• Fistula with clinical or radiological evidence of abscess
• Perianal CD with or without rectal involvement
• Ileostomy, colostomy, enteral or parenteral feeding
• Short gut syndrome.
• Clinical condition medically or surgically unstable that, at the discretion of the investigator would not be compatible with the patient's participation in the study
• Any malignant neoplasia, in the year prior to screening ,except for nonmelanoma skin cancer.
• 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 within the past 4 weeks (to limit potential confounding effects of exposure to nicotine)

Sponsors & Collaborators

• Indiana University: lead
• ElectroCore INC: collaborator

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Thomas Nowak, MD
• Organization: IndianaU

tvnowak@iu.edu

3179484272

Study Officials

• Sashidhar V Sagi, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

• Thomas V Nowak, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: December 21, 2021
• Study Start: November 30, 2021
• Primary Completion: August 12, 2022
• Study Completion: August 12, 2022
• Last Updated: March 6, 2025
• Results First Posted: March 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)