Epilepsy Trial, Recruiting NCT03953768 Sponsor: University of Louisville Condition: Epilepsy
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Epilepsy Trial, Recruiting

NCT03953768
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are receiving a vagus nerve stimulator (VNS) implant for the first time as a treatment for epilepsy.
  • People who have seen a neurologist based in Louisville within the past year, or — for those at the University of Utah or Baylor University sites — people with documented ability to travel to a neurologist at those locations.
  • People with documented ability to travel to Louisville for outpatient medical care, or — for those at the University of Utah or Baylor University sites — people with documented ability to travel to those facilities.

Who may not be able to join:

  • People who have previously been treated with a vagus nerve stimulator (other than the one being implanted as part of this study).
  • People who are currently pregnant.
  • People who currently have an active infection.
  • People who have a history of cancer or have previously received chemotherapy.
  • People who have a history of an autoimmune disease.
  • People who have taken certain strong anticholinergic medications (a type of medication that blocks specific nerve signals) within 30 days before enrolling — those on moderate or lower-strength versions will be reviewed on a case-by-case basis by the lead researcher.
  • People who begin strong anticholinergic medications after enrolling — the lead researcher will decide whether to delay, skip, or end participation in that case.
  • People who have taken strong corticosteroids (a type of anti-inflammatory medication) within 30 days before enrolling — those on moderate or lower-strength versions will be reviewed on a case-by-case basis by the lead researcher.
  • People who begin strong corticosteroids after enrolling — the lead researcher will decide whether to delay, skip, or end participation in that case.
  • People currently taking medications used to treat irregular heart rhythms or to control heart rate.
  • People who have a pre-existing irregular heart rhythm, or who have a cardiac pacemaker or implanted defibrillator.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 5026295512

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
University of Louisville
Registry
ClinicalTrials.gov
Start date
1 April 2021
Est. completion
13 December 2025

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Metagenomic microbiome profile; Bowel movement frequency; Bowel habits; Immune Profile 1 - Flow cytometric profiling of cell populations; Immune Profile 2 - Ex vivo stimulation of cells in whole blood; Inflammatory Profile 1 - Meso Scale Discovery (or MSD) analysis for pro-inflammatory cytokines/chemokines; Inflammatory Profile 2 - Meso Scale Discovery (or MSD) analysis for metabolic hormones; Inflammatory Profile 3 - Metabolomics for Short Chain Fatty acids (SCFAs); Inflammatory Profile 4 - Intestinal inflammation and permeability markers

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov