EpilepsiesNCT07725601
VNS Algorithm for Advanced Dosing
A study testing Rapid Titration VNS programming and Standard VNS programming in people with Epilepsies, run by Fernando Vale at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Epilepsies
- What is being tested?
- Rapid Titration VNS programming and Standard VNS programming
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to 30 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are clinically determined to be candidates for VNS implantation for seizure control
- Subject/legally authorized representative able to provide informed consent.
Who cannot join
- Subjects with VNS system treating pathologies other than drug refractory epilepsy or medical co-morbidities that prevent any surgical intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wellstar MCG Hospital
Augusta, Georgia, 30912
Brandy Quarles, MPH, 7067210390, bquarles@augusta.edu
About this study
Official title: VNS Algorithm for Advanced Dosing: Example Guided Mode Titrations "The Augusta Way"
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:
- Attend up to 3 study visits every 3 months for 2 years
- Answer questionnaires to assess quality of life and cognitive function
- Maintain a diary of seizure activity
Read the 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.
- Conditions
- Epilepsies
- Being tested
- Rapid Titration VNS programming, Standard VNS programming
- Keywords
- Vagal Nerve Stimulation, Drug-Resistant Epilepsy
- Medical subject headings
- Epilepsy, Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Titration VNS programmingDevice
Modified programming of VNS that provides rapid titration
Standard VNS programmingDevice
Standard of Care VNS programming
| Study group | Role | What they receive |
|---|---|---|
| Augusta Way | Experimental | Modified programming of VNS that provides rapid titration Receives: Device: Rapid Titration VNS programming |
| Control | Active comparator | Standard of care VNS programming Receives: Device: Standard VNS programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure Diary
A seizure diary is a personalized log used to record seizure activity, medication adherence, and potential triggers
Measured: From enrollment to end of participation at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 Aug 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fernando Vale
- Sponsor type
- University, hospital or other
- Collaborators
- Augusta University
- Responsible party
- Sponsor-investigator, Fernando Vale, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725601
- Sponsor's protocol ID
- 2094518
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VNS Algorithm for Advanced Dosing: Example Guided Mode Titrations "The Augusta Way"
- ClinicalTrials.gov ID
- NCT07725601
- Acronym / sponsor ID
- 2094518
- Conditions
- Epilepsies
- Keywords
- Vagal Nerve Stimulation, Drug-Resistant Epilepsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fernando ValeUniversity, hospital or other
- Collaborators
- Augusta University
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Attend up to 3 study visits every 3 months for 2 years
- Answer questionnaires to assess quality of life and cognitive function
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Augusta Way | Experimental | Device: Rapid Titration VNS programmingModified programming of VNS that provides rapid titration |
| Control | Active comparator | Device: Standard VNS programmingStandard of care VNS programming |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects who are clinically determined to be candidates for VNS implantation for seizure control
- Subject/legally authorized representative able to provide informed consent.
Key exclusion criteria (1 listed)
- Subjects with VNS system treating pathologies other than drug refractory epilepsy or medical co-morbidities that prevent any surgical intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid Titration VNS programmingModified programming of VNS that provides rapid titration | Device | Augusta Way |
| Standard VNS programmingStandard of Care VNS programming | Device | Control |
Primary outcome
Seizure Diary
Time frame: From enrollment to end of participation at 2 years
A seizure diary is a personalized log used to record seizure activity, medication adherence, and potential triggers
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid Titration VNS programming and Standard VNS programming in people with Epilepsies, run by Fernando Vale at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brandy Quarles, MPH (706-721-0390, bquarles@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure Diary (time frame: From enrollment to end of participation at 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.