Vagus Nerve Stimulation for Crohn's Disease
(VNS Trial)

Recruiting in Palo Alto (17 mi)

Overseen byThomas V Nowak, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Indiana University

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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

Research Team

Sashidhar V Sagi, MD

Principal Investigator

Indiana University School of Medicine

Thomas V Nowak, MD

Principal Investigator

Indiana University School of Medicine

Eligibility Criteria

Adults with active Crohn's disease for at least 3 months, confirmed by tests and not on high-dose steroids. They must have symptoms despite treatment, no recent surgeries or infections, and can't be pregnant or using tobacco. Participants need to agree to the study rules and not have certain heart conditions or metal implants in the neck.

Inclusion Criteria

My immunosuppressive medication dose has been stable.

My last colonoscopy showed no signs of colon issues or cancer.

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

See 5 more

Exclusion Criteria

I expect to start or increase my use of corticosteroids or immunosuppressive drugs.

I have been diagnosed with narrowed arteries in my neck.

I have a condition likely to need steroid treatment.

See 25 more

Treatment Details

Interventions

Vagal Nerve Stimulator (Vagus Nerve Stimulator)

Trial OverviewThe trial is testing a non-invasive device that stimulates the vagus nerve through the skin to see if it's safe and effective for treating Crohn's disease symptoms in adults who haven't responded well to conventional therapies.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Non-Invasive VNSExperimental Treatment1 Intervention

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