RESEARCH EVALUATING VAGAL EXCITATION AND ANATOMICAL LINKS
This study examines how vagal nerve stimulation (VNS), a treatment that sends mild electrical pulses to a nerve in the neck, affects various body systems in people with epilepsy. Researchers will measure changes in heart rate, immune function, metabolism, and other body responses through non-invasive tests and blood samples taken at different points during the study.
Key Objective: This trial is testing whether VNS can improve seizure control and overall health by understanding how it affects the nervous system, heart function, immune response, and metabolism.
Who to Consider: People with epilepsy who are interested in exploring how vagal nerve stimulation might help control their seizures and improve their overall health should consider enrolling.
Trial Parameters
Brief Summary
The acute and chronic effects of VNS stimulation on various on the autonomic nervous, cardiovascular, immune, and metabolic systems will be compared from noninvasive and minimally invasive physiological recordings and blood draws at various time points throughout the study. These interventions and assessments will be performed in individuals 18 years of age and older who are implanted with a VNS device, which consists of patients who have been diagnosed with drug resistant epilepsy or major depressive disorder. The REVEAL study is not a treatment study; its primary objective is to scientifically investigate the contributing roles of efferent versus afferent vagus nerve modulation of multiple peripheral organs and their dependence on stimulation parameters, in which participants are those who have been implanted with a VNS device be receive standard of care treatment for their epilepsy or depressive disorder.
Eligibility Criteria
Inclusion Criteria: Cohort 1a (p-VNS): Inclusion Criteria for Participants With Major Depressive Disorder That Have a Previously Implanted VNS Device * Participant must be at least 18 years old. * Participant must have the capacity to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization. * Participant must be enrolled in an active health insurance plan that will cover the costs associated with standard health care services and injuries. * Participant must have been previously implanted with a VNS device for the clinical indication of Major Depressive Disorder (MDD). * Participant must be able and willing to complete the evaluations and procedures described in the study protocol. * Participant's usage of concomitant medications must be stable for two months preceding study enrollment and the participant must be able and willing to maintain stable usage of any concomitant medications from the day of enrollment through the completi