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Neurostimulation Device
VNS for Epilepsy (VNS-IG 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 belowSelect...
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:Select...
I have previously been treated with VNS.
Select...
I have a heart rhythm problem or a device like a pacemaker.
Select...
I have taken steroids in the last month or might during the study.
Select...
I have not taken immunomodulators in the last month.
Select...
I have undergone chemotherapy in the past.
Select...
I am not currently pregnant.
Select...
I have had cancer in the past.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Bowel habits
Bowel movement frequency
Immune Profile 1 - Flow cytometric profiling of cell populations
+6 moreSecondary 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?
LivaNovaIndustry Sponsor
65 Previous Clinical Trials
31,258 Total Patients Enrolled
5 Trials studying Epilepsy
972 Patients Enrolled for Epilepsy
Norton FoundationUNKNOWN
University of LouisvilleLead Sponsor
348 Previous Clinical Trials
77,348 Total Patients Enrolled
National Institute of General Medical Sciences (NIGMS)NIH
299 Previous Clinical Trials
248,997 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously been treated with VNS.I have a heart rhythm problem or a device like a pacemaker.I have taken steroids in the last month or might during the study.I have not taken immunomodulators in the last month.I have undergone chemotherapy in the past.I am getting a VNS device for my epilepsy for the first time.I am not currently pregnant.I have had cancer in the past.I have not taken any cholinergic or anticholinergic medication in the last month.
Research Study Groups:
This trial has the following groups:- Group 1: Patients undergoing device implantation
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.