VNS Algorithm for Advanced Dosing

Conditions

• Epilepsies

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Rapid Titration VNS programming — DEVICE
  Modified programming of VNS that provides rapid titration
• Standard VNS programming — DEVICE
  Standard of Care VNS programming

Study Details

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

Key Dates

First listed

Jul 24, 2026

Start date

Aug 1, 2025

Status verified

Jul 2026

Primary completion

Dec 31, 2028

Completion

Dec 30, 2030

Study Design

Enrollment

80 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Augusta Way
  Modified programming of VNS that provides rapid titration
• Active Comparator: Control
  Standard of care VNS programming

Primary Outcome Measure

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

Central Contacts

• Brandy Quarles, MPH
  706-721-0390
  [email protected]

Locations (1)

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