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VNS Algorithm for Advanced Dosing

NCT07725601 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-07-24

No results posted yet for this study

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

Interventions

DEVICE

Rapid Titration VNS programming

Modified programming of VNS that provides rapid titration

DEVICE

Standard VNS programming

Standard of Care VNS programming

Sponsors & Collaborators

  • Augusta University

    collaborator OTHER

  • Fernando Vale

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2028-12-31
Completion
2030-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07725601 on ClinicalTrials.gov