Active — Not RecruitingNot Applicable

RESEARCH EVALUATING VAGAL EXCITATION AND ANATOMICAL LINKS

United States, Australia144 participantsStarted 2023-12-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 completion of Study Visit 2. * Participant that is of childbearing potential must be adequately protected from conception or willing to use an acceptable method of birth control over the entire study duration (acceptable birth control includes abstinence, barrier methods, hormonal methods, sterilization and fertility awareness). Cohort 1b (n-VNS): Inclusion Criteria for Participants With Major Depressive Disorder That Will Receive a Newly Implanted VNS Device * Participant must be at least 18 years …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Muscle Sympathetic Nerve Burst Incidence with Vagus nerve stimulation

Timeframe: baseline and 12 weeks

Change in Muscle Sympathetic Nerve Burst Frequency with Vagus nerve stimulation

Timeframe: baseline and 12 weeks

Change in Muscle Sympathetic Nerve Burst Area with Vagus nerve stimulation

Timeframe: baseline and 12 weeks

Effect of Vagus nerve stimulation on Isometric Hand Grip-mediated changes in Heart Rate

Timeframe: baseline and 12 weeks

Effect of Vagus nerve stimulation on Isometric Hand Grip-mediated changes in Blood pressure

Timeframe: baseline and 12 weeks

Effect of Vagus nerve stimulation on Isometric Hand Grip-mediated changes in Muscle Sympathetic Nerve Activity (MSNA)

Timeframe: baseline and 12 weeks

Effect of Vagus nerve stimulation on Post-exercise circulatory occlusion-mediated change in Heart Rate

Trial details

NCT IDNCT06143293

SponsorUniversity of Minnesota

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-31

View on ClinicalTrials.gov More Epilepsy trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Muscle Sympathetic Nerve Burst Incidence with Vagus nerve stimulation

Timeframe: baseline and 12 weeks

Change in Muscle Sympathetic Nerve Burst Frequency with Vagus nerve stimulation

Timeframe: baseline and 12 weeks

Change in Muscle Sympathetic Nerve Burst Area with Vagus nerve stimulation

Timeframe: baseline and 12 weeks

Effect of Vagus nerve stimulation on Isometric Hand Grip-mediated changes in Heart Rate

Timeframe: baseline and 12 weeks

Effect of Vagus nerve stimulation on Isometric Hand Grip-mediated changes in Blood pressure

Timeframe: baseline and 12 weeks

Effect of Vagus nerve stimulation on Isometric Hand Grip-mediated changes in Muscle Sympathetic Nerve Activity (MSNA)

Timeframe: baseline and 12 weeks

Effect of Vagus nerve stimulation on Post-exercise circulatory occlusion-mediated change in Heart Rate