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Vagus Nerve Stimulator
Vagus Nerve Stimulation for Crohn's Disease (VNS Trial)
N/A
Recruiting
Led By Sashidhar V Sagi, MD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Colonoscopy within the previous 1 year with no evidence of colonic dysplasia or cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
VNS Trial Summary
This trial is testing a new way to treat Crohn's disease using electrical stimulation of the vagus nerve. The goal is to see if it is safe and effective.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site, headache, voice changes due to nerve stimulation, or an allergic reaction to device materials. Heart-related issues like changes in rhythm could occur but are monitored closely.
VNS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My Crohn's disease is active despite treatment, with a CDAI score over 220.
Select...
My last colonoscopy showed no signs of colon issues or cancer.
Select...
I have been on a stable dose of corticosteroids, not exceeding 20mg/day, for at least 14 days.
VNS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in fecal calprotectin over time
Secondary outcome measures
Change in Crohn's Disease Activity Index (CDAI) over time
Change in Insulin Levels After First Stimulation
Change in serum cytokine levels over time.
+1 moreVNS Trial Design
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.
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Who is running the clinical trial?
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
982,932 Total Patients Enrolled
ElectroCore INCIndustry Sponsor
30 Previous Clinical Trials
2,200 Total Patients Enrolled
Sashidhar V Sagi, MDPrincipal InvestigatorIndiana University School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I expect to start or increase my use of corticosteroids or immunosuppressive drugs.I have been diagnosed with narrowed arteries in my neck.My immunosuppressive medication dose has been stable.I have a condition likely to need steroid treatment.My last colonoscopy showed no signs of colon issues or cancer.My Crohn's disease affects the area around my anus, with or without affecting my rectum.My Crohn's disease symptoms are mild.I had bowel surgery in the last 90 days and am not on standard IBD treatment, or I plan to have surgery.I have been on a stable dose of corticosteroids, not exceeding 20mg/day, for at least 14 days.I have been diagnosed with Crohn's disease for over 3 months.My Crohn's disease is active despite treatment, with a CDAI score over 220.I have had surgery to cut the Vagus nerve in my neck.I have an abscess in my abdomen or near my rectum.I am currently taking antibiotics.I have untreated high or low blood pressure, or an irregular heartbeat.I have a stoma or need special feeding methods.I have short gut syndrome.I have a narrowed area in my bowel causing it to widen before the tight spot.I have a fistula with signs of an abscess.I haven't had any cancer except for nonmelanoma skin cancer in the last year.I have a heart condition that could cause irregular heartbeats.I do not speak English.I am currently taking medication for muscle spasms or bladder control.
Research Study Groups:
This trial has the following groups:- Group 1: Non-Invasive VNS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment criteria for this clinical trial restricted to those below a certain age?
"This medical research seeks study participants aged 18 to 75 years old. Those under the age of consent have 69 studies available, while those over 65 are invited to take part in 196 different trials."
Answered by AI
How many individuals are engaged in this clinical experiment?
"Affirmative. The information hosted on clinicaltrials.gov confirms that this medical study, which was posted on November 30th 2021 is still recruiting patients. At present there are 50 roles to fill at a single trial site."
Answered by AI
Are there any opportunities for individuals to participate in the experiment?
"Affirmative. The clinicaltrials.gov data verifies that this research, which was initially posted on November 30th 2021 is presently recruiting patients. Approximately 50 participants need to be recruited from one medical facility."
Answered by AI
Which individuals are eligible to be involved in this trial?
"This clinical trial is accepting 50 individuals aged 18 to 75 who suffer from ileocolitis. To be considered, a patient's Crohn's disease Activity Index must exceed 220 and fall beneath 450 despite having already taken conventional medications such as corticosteroids or immunosuppressants for 14 days at a steady dose of no more than 20mg/day prednisone (or the equivalent). Furthermore, participants should have been using biologics like Infliximab, Adalimumab, Vedolizumab, Ustekinumab etc., for 112 days prior to enrollment."
Answered by AI
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