Actively Recruiting
RESEARCH EVALUATING VAGAL EXCITATION AND ANATOMICAL LINKS
Led by University of Minnesota · Updated on 2026-04-03
144
Participants Needed
7
Research Sites
141 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
RESEARCH EVALUATING VAGAL EXCITATION AND ANATOMICAL LINKS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be at least 18 years old.
- Have the ability to provide written informed consent and HIPAA authorization.
- Be enrolled in an active health insurance plan covering standard healthcare and injury costs.
- Have a previously implanted VNS device or be scheduled to receive one for major depressive disorder or drug resistant epilepsy.
- For depression, meet diagnostic criteria for chronic or recurrent episodes and have a Montgomery-�C5sberg Depression Rating Scale (MADRS) score of 22 or higher if newly implanted.
- Have stable use of concomitant medications for at least two months before enrollment and agree to maintain stability throughout the study.
- Be willing and able to complete all study evaluations and procedures.
- If of childbearing potential, use acceptable birth control methods or abstinence during the entire study period.
You will not qualify if you...
- Have a prior implantable stimulation device other than a VNS device for the relevant condition.
- Use or expect to use short-wave diathermy, microwave, diathermy, or therapeutic ultrasound diathermy during the study.
- Be acutely suicidal within the last 30 days or have attempted suicide within 6 months before enrollment.
- Have a history of schizophrenia-spectrum or other psychotic disorders, psychotic depression, significant borderline or severe personality disorder, or active primary obsessive-compulsive, eating, or post-traumatic stress disorder.
- Have substance use disorder without sustained remission for 12 months or longer.
- Have any type of dementia, major neurocognitive disorder, or cognitive or psychiatric deficit.
- Have a history of rapid cycling bipolar disorder I or II.
- Be currently receiving treatment with another investigational device or drug or have participated in such a trial within 30 days before enrollment.
- Be unable or unwilling to use the dominant arm or have either upper arm circumference greater than 50 cm.
- Not speak English.
- Have other clinical conditions deemed inappropriate by investigators, such as peripheral vascular disease, Raynaud's phenomenon, orthostatic hypotension, postural orthostatic tachycardia syndrome, uncontrolled obstructive sleep apnea, chronic obstructive pulmonary disease, or uncontrolled diabetes.
- For epilepsy participants, have demonstrated benefit from VNS in seizure control or epilepsy-related quality of life.
- Have been hospitalized for psychiatric conditions in the past 6 months or had psychosis in the past 2 years (excluding postictal psychosis).
- Have experienced unprovoked status epilepticus in the past year.
- Have vocal cord paralysis (for newly implanted epilepsy and depression participants).
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Stanford University
Stanford, California, United States, 54304
Actively Recruiting
2
University of Minnesota
Minneapolis, Minnesota, United States, 55414
Actively Recruiting
3
Washington University in St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
4
Alivation Research, LLC
Lincoln, Nebraska, United States, 68526
Not Yet Recruiting
5
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
6
Alfred Health
Melbourne, Victoria, Australia, 3004
Actively Recruiting
7
99 Commercial Road
Prahan, Victoria, Australia, 3182
Actively Recruiting
Research Team
K
Kathryn Vera
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
6
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