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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
Must not have
Previous treatment with VNS
Pre-existing cardiac arrhythmia or presence of cardiac pacemaker/defibrillator
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have previously been treated with VNS.
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I have a heart rhythm problem or a device like a pacemaker.
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I have taken steroids in the last month or might during the study.
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I have not taken immunomodulators in the last month.
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I have undergone chemotherapy in the past.
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I am not currently pregnant.
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I have had cancer in the past.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
347 Previous Clinical Trials
77,571 Total Patients Enrolled
National Institute of General Medical Sciences (NIGMS)NIH
294 Previous Clinical Trials
248,955 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
~6 spots leftby Dec 2025
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