Optimization of VNS in Epileptic Patients to Induce Cardioprotection
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|ClinicalTrials.gov Identifier: NCT04387435|
Recruitment Status : Recruiting
First Posted : May 13, 2020
Last Update Posted : October 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy Sudden Cardiac Death||Other: A change or titration in the current or frequency settings of the VNS therapy system.||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Feasibility Study to Evaluate the Safety and Effect of the Optimization of Vagus Nerve Stimulation in Epileptic Patients to Induce Cardioprotection|
|Actual Study Start Date :||December 1, 2020|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||July 2022|
- Other: 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.
- 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. ]
- 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). ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04387435
|Contact: Julie M Sorg, MSNemail@example.com|
|Contact: Olujimi Ajijola, MD, PhD|
|United States, California|
|Los Angeles, California, United States, 90095|
|Contact: Inna Keselman, MD, PhD|
|Sub-Investigator: Olujimi Ajijola, MD, PhD|
|Sub-Investigator: Jeffrey Ardell, PhD|
|Sub-Investigator: Jason Bradfield, MD|
|Sub-Investigator: Kalyanam Shivkumar, MD, PhD|
|Sub-Investigator: Marmar Vaseghi, MD, PhD|
|Principal Investigator:||Inna Keselman, MD, PhD||University of California, Los Angeles|