RecruitingNot ApplicableNCT06143293

RESEARCH EVALUATING VAGAL EXCITATION AND ANATOMICAL LINKS


Sponsor

University of Minnesota

Enrollment

144 participants

Start Date

Dec 15, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This research study investigates how vagus nerve stimulation (VNS) — a treatment that sends mild electrical signals to the brain via a device implanted near the collarbone — affects brain function. It enrolls people with major depression or drug-resistant epilepsy who either already have a VNS device or are about to get one. **You may be eligible if...** - You are 18 or older - You have major depression or drug-resistant epilepsy - You either already have a VNS device implanted, or your doctor has recommended you get one - For depression: you have failed at least four different antidepressant treatments - Your medications have been stable for at least two months - You have health insurance and are willing to use a blood pressure cuff on your arm **You may NOT be eligible if...** - You have another type of implanted stimulation device - You are currently suicidal or have attempted suicide in the last 6 months - You have a psychotic disorder (like schizophrenia) or rapid cycling bipolar disorder - You have dementia or severe cognitive problems - You have active substance use disorder - You do not speak English - You have certain health conditions such as severe sleep apnea, COPD, or uncontrolled diabetes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVagus nerve stimulation device: acute and chronic administration of investigational vagus nerve stimulation parameters

Duty cycle: At Visit 1, while the frequencies are being changed over Period 1, 2, and 3, duty cycle will be held constant at the participant's randomly assigned first duty cycle setting. At Visit 2, duty cycle will be held constant at the participant's randomly assigned second duty cycle setting. At Visit 2 the participant will receive whichever duty cycle they were not randomly assigned at Visit 1. Therefore, by completing the combination of three frequencies at two duty cycles, each participant will have received all six possible VNS parameter combinations over the two study visits. Chronic period: The VNS setting for the Chronic Period in between Visit 1 and Visit 2 will be the same settings as tested during Visit 1 Period 3. Since Visit 1 Period 3 settings were already randomly assigned to each participant, another randomization for the chronic period is not needed.


Locations(7)

Stanford University

Stanford, California, United States

University of Minnesota

Minneapolis, Minnesota, United States

Washington University in St. Louis

St Louis, Missouri, United States

Alivation Research, LLC

Lincoln, Nebraska, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Alfred Health

Melbourne, Victoria, Australia

99 Commercial Road

Prahan, Victoria, Australia

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NCT06143293


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