VNS Dosing Protocol: Faster Seizure Control for Epilepsy
Official title: VNS Algorithm for Advanced Dosing: Example Guided Mode Titrations "The Augusta Way"
Run by Augusta University · NCT07725601 · Data updated 2026-11-12
This trial tests a faster VNS programming method versus standard settings to see if seizures subside sooner in adults with drug-resistant epilepsy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Augusta University Academic / other |
| Locations | 1 site (Augusta, Georgia) |
| Status | Recruiting |
| Started | August 1, 2025 |
| Main results expected | December 31, 2028 |
| Study ends | December 30, 2030 |
| Registry record updated | July 24, 2026 |
| Trial ID | NCT07725601 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with drug-resistant epilepsy who are candidates for VNS implantation and can provide informed consent.
✕Probably not a fit
Patients whose seizures do not respond to VNS or who cannot complete the titration protocol may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares two VNS programming paradigms in adults with epilepsy: a modified rapid titration approach called the Augusta Way and the standard titration used in routine care. Participants will have up to three visits every three months over two years, complete quality-of-life and cognitive questionnaires, and keep a seizure diary. The study aims to determine if the Augusta Way reduces seizure frequency more quickly while monitoring safety and tolerability. Results will inform clinicians about a potentially updated reference model for VNS parameter escalation in drug-resistant epilepsy. Enrollment is limited to adults eligible for VNS implantation at Augusta University and Wellstar MCG Hospital, with informed consent obtained.
Why it matters
Potential benefit: If successful, patients may experience faster seizure reduction and improved quality of life with a refined VNS dosing protocol.
How similar studies have gone: Prior VNS trials have supported individualized programming, but this specific rapid titration approach is novel and requires confirmation of safety and efficacy.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects who are clinically determined to be candidates for VNS implantation for seizure control * Subject/legally authorized representative able to provide informed consent. Exclusion Criteria: * Subjects with VNS system treating pathologies other than drug refractory epilepsy or medical co-morbidities that prevent any surgical intervention
Where it's running
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Wellstar MCG Hospital
Augusta, Georgia, United States Recruiting
Study contacts
- Study coordinator: Brandy Quarles, MPH
- Email: bquarles@augusta.edu
- Phone: 706-721-0390
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.