VNS Algorithm for Advanced Dosing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rapid Titration VNS programming, Standard VNS programming.
- Who it may be relevant to
- Registry conditions: Epilepsies. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
VNS Algorithm for Advanced Dosing: Example Guided Mode Titrations "The Augusta Way"
Overview
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
Detailed description
Little has changed in the last 10 years or more in regard to Vagus nerve stimulator (VNS) therapy programming parameters despite new technological advances. The goal of our study is to provide a comprehensive VNS dosing protocol which VNS programmers can refer to as the standard care of treatment escalation in patients with drug refectory epilepsy. Given the lack of newly published data regarding VNS system parameters, this study will allow epileptologists, general neurologists and neurosurgeons alike, access to an updated reference and model of VNS parameter escalation and treatment.
The investigators at Augusta University have developed a programming paradigm that appears to provide good clinical outcomes for VNS patients. The study will provide a comprehensive assessment of an experimental group ("the Augusta Way") programmed with a modified, more rapid titration paradigm developed at our site vs. "best clinical practice" (standard titration paradigm) control group of patients with VNS devices. The patients will be followed for at least 24 months post implantation. The study will assess safety of the new programming paradigm and will assess efficacy based upon seizure outcomes.
Interventions
- Device Rapid Titration VNS programming
Modified programming of VNS that provides rapid titration - Device Standard VNS programming
Standard of Care VNS programming
Primary outcome measures
- Seizure Diary [Time frame: From enrollment to end of participation at 2 years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Wellstar MCG Hospital — Augusta
Identifiers
NCT: NCT07725601 · 2094518