NCT07725601

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
54mo left

Started Aug 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Aug 2025Dec 2030

Study Start

First participant enrolled

August 1, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2030

Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

3.4 years

First QC Date

July 21, 2026

Last Update Submit

July 23, 2026

Conditions

Epilepsies

Keywords

Vagal Nerve StimulationDrug-Resistant Epilepsy

Outcome Measures

Primary Outcomes (1)

  • Seizure Diary

    A seizure diary is a personalized log used to record seizure activity, medication adherence, and potential triggers

    From enrollment to end of participation at 2 years

Study Arms (2)

Augusta Way

EXPERIMENTAL

Modified programming of VNS that provides rapid titration

Device: Rapid Titration VNS programming

Control

ACTIVE COMPARATOR

Standard of care VNS programming

Device: Standard VNS programming

Interventions

Rapid Titration VNS programmingDEVICE

Modified programming of VNS that provides rapid titration

Augusta Way
Standard VNS programmingDEVICE

Standard of Care VNS programming

Control

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who are clinically determined to be candidates for VNS implantation for seizure control
  • Subject/legally authorized representative able to provide informed consent.

You may not qualify if:

  • Subjects with VNS system treating pathologies other than drug refractory epilepsy or medical co-morbidities that prevent any surgical intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wellstar MCG Hospital

Augusta, Georgia, 30912, United States

RECRUITING

MeSH Terms

Conditions

EpilepsyDrug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Brandy Quarles, MPH

CONTACT

706-721-0390bquarles@augusta.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Allen Distinguished Chair in Neurosurgery

Study Record Dates

First Submitted

July 21, 2026

First Posted

July 24, 2026

Study Start

August 1, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 30, 2030

Last Updated

July 24, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)