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RESEARCH EVALUATING VAGAL EXCITATION AND ANATOMICAL LINKS | Clinical Trials | Clareo Health

RECRUITINGNA

RESEARCH EVALUATING VAGAL EXCITATION AND ANATOMICAL LINKS

NCT06143293•University of Minnesota

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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).
•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.
+24 more criteria

Exclusion Criteria

•Participant has a prior implantable stimulation device, other than a VNS device for the clinical indication of Major Depressive Disorder (MDD).
•Participant currently uses or is expected during the study to use short-wave diathermy, microwave, diathermy, or therapeutic ultrasound diathermy.
•Participant is judged by the investigator to be acutely suicidal (e.g. has made specific plans or preparations to commit suicide or as indicated by the Sheehan Suicidality Tracking Scale) within the last 30 days prior to study enrollment.
•Participant has made a suicide attempt within the previous 6 months from study enrollment.
•Participant has a history of one or more schizophrenia-spectrum or other psychotic disorders including schizophrenia, schizoaffective disorder, delusional disorder, or a current or lifetime major depressive episode that includes psychotic features (commonly referred to as psychotic depression) according to the MINI criteria.
•Participant has a history of significant borderline or severe personality disorder as determined by clinical judgment.
•Participant has an active primary diagnosis of obsessive-compulsive, eating, or post-traumatic stress disorder based on the MINI criteria.
•Participant has a diagnosis of Substance Use Disorder as defined by DSM-5 without sustained remission of 12 months or longer.
•Participant has a presence of any type of dementia, major neurocognitive disorder, or cognitive or psychiatric deficit as determined by clinical judgment.
•Participant has a history of rapid cycling bipolar disorder I or II.
+39 more criteria

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Key Dates

Start Date

December 15, 2023

Primary Completion Date

August 31, 2026

Completion Date

August 31, 2026

Last Updated

January 14, 2026

Enrollment

144

ESTIMATED participants

Conditions

EpilepsyDepressive Disorder

Interventions

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

DEVICE

Contacts

Kathryn Vera

CONTACT

612-625-5018 giero002@umn.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 14, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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RESEARCH EVALUATING VAGAL EXCITATION AND ANATOMICAL LINKS

Inclusion Criteria

Exclusion Criteria

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