Recruiting

VNS vs. Augusta Way

Sponsor:

Fernando Vale

Code:

NCT07725601

Conditions

Epilepsies

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Rapid Titration VNS programming

Standard VNS programming

Study Details

Brief summary:

The goal of this clinical trial is to compare the standard programming of the VNS device (Control) to a modified programming (Augusta Way) in adults with epilepsy. The main question it aims to answer is:

Does the modified programming of the VNS reduce seizures faster than the standard programming?

Participants in both groups will:

1. Attend up to 3 study visits every 3 months for 2 years
2. Answer questionnaires to assess quality of life and cognitive function
3. Maintain a diary of seizure activity

Conditions

Epilepsies

Study ID

NCT07725601

Start date

Aug 1, 2025

Status verified date

Jul, 2026

Completion date

Dec 30, 2030

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Augusta Way

Modified programming of VNS that provides rapid titration

active comparator: Control

Standard of care VNS programming

Interventions

Rapid Titration VNS programming

Modified programming of VNS that provides rapid titration

Standard VNS programming

Standard of Care VNS programming

Primary outcome measure

  • Seizure Diary [ Time Frame: From enrollment to end of participation at 2 years ]

Central Contacts and Locations

Central contacts

Brandy Quarles, MPH

706-721-0390bquarles@augusta.edu

Locations

Wellstar MCG Hospital

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Brandy Quarles, MPH

7067210390bquarles@augusta.edu

More Information

Sponsor

Fernando Vale

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

  • Vagal Nerve Stimulation
  • Drug-Resistant Epilepsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Fernando Vale on 2026-07-24.