EpilepsyNCT04387435
Optimization of VNS in Epileptic Patients to Induce Cardioprotection
A study testing A change or titration in the current or frequency settings of the VNS therapy system. in people with Epilepsy and Sudden Cardiac Death, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study is a non-randomized, prospective study in patients with a diagnosis of epilepsy and previously implanted FDA approved Vagus Nerve Stimulation (VNS) devices. The goal of this clinical investigation is to evaluate the effects of adjusting vagus nerve stimulation parameters to engage cardioprotective effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Sudden Cardiac Death
- What is being tested?
- A change or titration in the current or frequency settings of the VNS therapy system.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 7 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of refractory epilepsy and implanted with a VNS device or are scheduled to be implanted with a VNS device.
- 18 years of age or older
- Subjects must demonstrate willingness and ability to comply with study requirements
Who cannot join
- Other implantable neuromodulatory device (e.g., brain stimulator)
- Treatment with cholinergic or anticholinergic medication in the past month
- Pre-existing cardiac arrhythmia or presence of cardiac pacemaker/defibrillator
- History of dysautonomias
- History of vasovagal syncope
- Progressive neurological diseases other than epilepsy
- Women that are pregnant
- Cognitive or psychiatric deficit that in the investigator's judgment would interfere with the subject's ability to accurately complete study assessments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study to Evaluate the Safety and Effect of the Optimization of Vagus Nerve Stimulation in Epileptic Patients to Induce Cardioprotection
This study is a non-randomized, prospective study in patients with a diagnosis of epilepsy and previously implanted FDA approved Vagus Nerve Stimulation (VNS) devices. The goal of this clinical investigation is to evaluate the effects of adjusting vagus nerve stimulation parameters to engage cardioprotective effects.
Read the detailed description
Epilepsy patients are at increased risk for sudden cardiac death. Mechanisms behind this predisposition is poorly understood but parasympathetic dysfunction is heavily implicated. Vagus Nerve Stimulation (VNS) protocols currently set for seizure management are poorly optimized for cardioprotection, therefore this patient population presents a unique opportunity to assess VNS control of cardiac function, when VNS is appropriately titrated for cardiac and seizure benefit.
This study will enroll 12 patients with a diagnosis of epilepsy and previously implanted FDA approved VNS devices. The study will last up to 9 weeks and the patient will undergo changes to their VNS settings during autonomic testing and cardiopulmonary testing.
- Conditions
- Epilepsy, Sudden Cardiac Death
- Being tested
- A change or titration in the current or frequency settings of the VNS therapy system.
- Keywords
- Vagus Nerve Stimulation (VNS), Neuromodulation, Autonomics
- Medical subject headings
- Epilepsy, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A change or titration in the current or frequency settings of the VNS therapy system.Other
The study treatment involves changing the output current or frequency of the default device settings in a FDA approved device for VNS therapy. The proposed frequency changes in this study are within the FDA approved output current and frequency levels.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Single arm Receives: Other: A change or titration in the current or frequency settings of the VNS therapy system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Seizure Frequency or Duration Via a Routine Seizure History Used in Clinical Practice.
Measured: Following the 4 - week VNS treatment phase to the of the end of study.
Secondary outcomes (1)
Change in Heart Rate and Blood Pressure in Response to Upright Tilt, Deep Breathing, Valsalva Maneuver and a Cold Pressor Test.
Measured: From pre VNS setting changes (baseline) to post VNS setting changes (end of study).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start1 Dec 2020
- Primary completion7 Jul 2021
- Study completion7 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Olujimi Ajijola, University of California, Los Angeles
- Investigators
- Olujimi Ajijola, MD, PhD, Principal investigator, UCLA Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387435
- Sponsor's protocol ID
- 19-002279
- Other IDs
- OT2OD028201
- Status last verified
- Mar 2025
- First submitted
- 4 May 2020
- Last updated
- 6 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Evaluate the Safety and Effect of the Optimization of Vagus Nerve Stimulation in Epileptic Patients to Induce Cardioprotection
- ClinicalTrials.gov ID
- NCT04387435
- Acronym / sponsor ID
- 19-002279
- Conditions
- Epilepsy, Sudden Cardiac Death
- Keywords
- Vagus Nerve Stimulation (VNS), Neuromodulation, Autonomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 7 Jul 2021 (actual)
- Study completion
- 7 Jul 2021 (actual)
- First posted
- 13 May 2020 (actual)
- Results
- Posted 28 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a non-randomized, prospective study in patients with a diagnosis of epilepsy and previously implanted FDA approved Vagus Nerve Stimulation (VNS) devices. The goal of this clinical investigation is to evaluate the effects of adjusting vagus nerve stimulation parameters to engage cardioprotective effects.
Detailed description
Epilepsy patients are at increased risk for sudden cardiac death. Mechanisms behind this predisposition is poorly understood but parasympathetic dysfunction is heavily implicated. Vagus Nerve Stimulation (VNS) protocols currently set for seizure management are poorly optimized for cardioprotection, therefore this patient population presents a unique opportunity to assess VNS control of cardiac function, when VNS is appropriately titrated for cardiac and seizure benefit.
This study will enroll 12 patients with a diagnosis of epilepsy and previously implanted FDA approved VNS devices. The study will last up to 9 weeks and the patient will undergo changes to their VNS settings during autonomic testing and cardiopulmonary testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: A change or titration in the current or frequency settings of the VNS therapy system.Single arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of refractory epilepsy and implanted with a VNS device or are scheduled to be implanted with a VNS device.
- 18 years of age or older
- Subjects must demonstrate willingness and ability to comply with study requirements
Key exclusion criteria (8 listed)
- Other implantable neuromodulatory device (e.g., brain stimulator)
- Treatment with cholinergic or anticholinergic medication in the past month
- Pre-existing cardiac arrhythmia or presence of cardiac pacemaker/defibrillator
- History of dysautonomias
- History of vasovagal syncope
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 |
|---|---|---|
| A change or titration in the current or frequency settings of the VNS therapy system.The study treatment involves changing the output current or frequency of the default device settings in a FDA approved device for VNS therapy. The proposed frequency changes in this study are within the FDA approved output current and frequency levels. | Other | Intervention Arm |
Primary outcome
Change in Seizure Frequency or Duration Via a Routine Seizure History Used in Clinical Practice.
Time frame: Following the 4 - week VNS treatment phase to the of the end of study.
1 secondary outcome
Change in Heart Rate and Blood Pressure in Response to Upright Tilt, Deep Breathing, Valsalva Maneuver and a Cold Pressor Test.
Time frame: From pre VNS setting changes (baseline) to post VNS setting changes (end of study).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
Olujimi Ajijola, MD, PhD principal investigator
UCLA Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A change or titration in the current or frequency settings of the VNS therapy system. in people with Epilepsy and Sudden Cardiac Death, run by University of California, Los Angeles 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 6 Apr 2025. 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?
Yes. Results are posted in the registry (first posted 28 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Seizure Frequency or Duration Via a Routine Seizure History Used in Clinical Practice. (time frame: Following the 4 - week VNS treatment phase to the of the end of study.). 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 6 Apr 2025.