Non-invasive Vagus Nerve Stimulation in the treatment of Crohn’s disease

S
Sashidhar Sagi, MD

Primary Investigator

Administratively Closed
18 years - 100 years
All
Phase N/A
5 participants needed
1 Location

Brief description of study

What is the purpose of this study?
The purpose of this study is to assess the safety and efficacy of transcutaneous vagal nerve stimulation (T-VNS) in adult patient with active Crohn’s disease. The investigators are conducting this research to see if transcutaneous VNS will decrease inflammation in people with Crohn’s disease leading to decrease in inflammatory markers and symptoms of disease.

Detailed description of study

What will happen during the study?
  • Participants in this study will continue taking Crohn’s medications as prescribed by your doctor. 
  • They will self-administer the T-VNS using a device provided.
  •  Participants self-administer the T-VNS for 16 weeks and record them in a diary.
  •  Participants will have three study visits in which they will be asked to give a stool sample, blood draw, ECG, and some questionnaires.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Crohn's Disease
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria:
  • 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 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:
  • 56 days (8 weeks) for Immunomodulators (methotrexate, 6-MP, Azathioprine) and small molecules (upadacitinib)
  • 84 days (12 weeks) for biologics (Infliximab, Adalimumab, Vedolizumab, Ustekinumab,  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. Labs done clinically within the past 30 days will be used for this criterion and will not need to be repeated for inclusion in the study. 
  • 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.
Exclusion Criteria:
  • 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)
  • 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
  • Participation in any other Investigational drug and/or treatment currently or planned during the length of the study
  • Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention
  • Pregnancy or Lactation
  • Comorbid disease with high likelihood of requiring corticosteroid use
  • Inability to comply with study and follow-up procedures
  • Non-English speaking.
  • Known cardiac condition causing or with potential to cause arrhythmia
  • Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
  • Patients who have had surgery to cut the Vagus nerve in the neck (cervical vagotomy)
  • Patients with clinically significant untreated hypertension, hypotension, bradycardia, or tachycardia.
  • Have a metallic device such as a stent, bone plate or bone screw implanted at or near their neck.
  • Are using another device at the same time (e.g., TENS Unit, muscle stimulator)

Updated on 01 Aug 2024. Study ID: 10734, GI-IIR-IBD-VNS

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