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RESEARCH EVALUATING VAGAL EXCITATION AND ANATOMICAL LINKS

StatusActive, Not Recruiting
PhaseNot applicable
Started2023-12-15
View on ClinicalTrials.gov ↗
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.

Amendment history 4 changes detected by DataLookout

2026-09-04
critical
Primary completion pushed: 2026-08-31 → 2027-08-31
2026-09-04
minor
Completion pushed: 2026-08-31 → 2027-08-31
2026-06-25
notable
Trial status changed: Recruiting → Active, Not Recruiting
2026-04-04
minor
Trial sites expanded: 1 → 7 locations
Trial Details
NCT Number NCT06143293
Lead Sponsor University of Minnesota
Conditions Epilepsy, Depressive Disorder
Enrollment 144 participants
Start Date 2023-12-15
Primary Completion 2027-08-31 (estimated)
Study Completion 2027-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-03