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Neurostimulation Device

VNS for Epilepsy (VNSAIG Trial)

N/A
Recruiting
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing VNS implantation for the first time as a treatment for epilepsy
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

VNSAIG Trial Summary

This trial is studying whether vagal nerve stimulation (VNS) for epilepsy affects bowel habits and the gut microbiome. VNS is a neurosurgical procedure where an impulse generator is placed near the vagus nerve in the neck.

Who is the study for?
This trial is for individuals with epilepsy who are getting a vagal nerve stimulator (VNS) implanted and can visit a Louisville-based neurologist. It's not for those who've had VNS before, have heart rhythm problems or devices, cancer history, recent immunomodulators or steroids use, current pregnancy, chemotherapy history, or recent cholinergic/anticholinergic drugs.Check my eligibility
What is being tested?
The study tests how VNS affects the gut microbiome and bowel habits in epilepsy patients. It also looks at changes in the autonomic and immune systems after surgery. The goal is to understand if these changes relate to how well VNS controls seizures.See study design
What are the potential side effects?
While not specified here, typical side effects of VNS may include voice alteration, coughing, throat pain or tingling during stimulation; headache; shortness of breath; difficulty swallowing; and neck pain.

VNSAIG Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am getting a VNS device for my epilepsy for the first time.

VNSAIG Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Abdominal pain
Bowel movement frequency
Immune Profile 1 - Flow cytometric profiling of cell populations
+6 more
Secondary outcome measures
Epilepsy severity

VNSAIG Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients undergoing device implantationExperimental Treatment1 Intervention
Patients undergoing device implantation with vagal nerve stimulator (VNS) for epilepsy

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor
336 Previous Clinical Trials
75,910 Total Patients Enrolled
National Institute of General Medical Sciences (NIGMS)NIH
268 Previous Clinical Trials
248,873 Total Patients Enrolled

Media Library

Vagal nerve stimulation (VNS) (Neurostimulation Device) Clinical Trial Eligibility Overview. Trial Name: NCT03953768 — N/A
Epilepsy Research Study Groups: Patients undergoing device implantation
Epilepsy Clinical Trial 2023: Vagal nerve stimulation (VNS) Highlights & Side Effects. Trial Name: NCT03953768 — N/A
Vagal nerve stimulation (VNS) (Neurostimulation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03953768 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities for new participants to join this experiment?

"According to clinicaltrials.gov this medical study is still recruiting patients as of today. The trial was first made publicly available on April 1st 2021, and the most recent update happened on November 7th 2022."

Answered by AI

Could I potentially be part of this research program?

"To participate in this clinical trial, individuals must be between 0 and 60 years old while suffering from IBD. Around 30 candidates will eventually be admitted to the study."

Answered by AI

What is the cap on the number of participants enrolled in this experiment?

"Indeed, according to clinicaltrials.gov, this trial is currently seeking participants; it was first published on April 1st 2021 and the last status update occurred on November 7th 2022. The study plans to recruit 30 individuals at two distinct sites."

Answered by AI

Is this research open to participants aged 75 and older?

"This clinical trial has set the minimum age requirement for enrollment at 0 and the maximum age limit is 60."

Answered by AI
~11 spots leftby Dec 2025