EpilepsyNCT06143293
RESEARCH EVALUATING VAGAL EXCITATION AND ANATOMICAL LINKS
A study testing Vagus nerve stimulation device: acute and chronic administration of investigational vagus nerve stimulation parameters in people with Epilepsy and Depressive Disorder, run by University of Minnesota at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Depressive Disorder
- What is being tested?
- Vagus nerve stimulation device: acute and chronic administration of investigational vagus nerve stimulation parameters
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 15 Dec 2023to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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 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 has a diagnosis of chronic (≥ 2 years) or ≥ 4 recurrent depressive episodes as defined by DSM-5 criteria documented using the MINI criteria and psychiatric medical record review. Participant must have VNS therapy clinically indicated.
- Participant has not had an adequate response to four or more adequate antidepressant treatments from at least two different antidepressant treatment categories in the current depressive episode according to the Antidepressant Treatment History Form (ATHF).
- Participant must have a score on the baseline administration of the Montgomery-Åsberg Depression Rating Scale (MADRS) of ≥ 22.
- 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 2a (p-VNS): Inclusion Criteria for Participants With Drug Resistant Epilepsy 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 drug resistant epilepsy.
- Participant has not had demonstrable benefit from the implanted VNS device in terms of epilepsy (seizure frequency or seizure severity) or related epilepsy comorbidities (mood, cognition, quality of life), with no definite improvement or suboptimal improvement in seizure control.
- Apart from epilepsy, the participant should be medically and neurologically stable.
- 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 2b (n-VNS): Inclusion Criteria for Participants With Drug Resistant Epilepsy That Will Receive a Newly 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 as well as the costs associated with the VNS implantation surgery.
- Participant is diagnosed with drug resistant epilepsy, with continuing seizures despite adequate trials of at least 2 appropriate antiseizure drugs (ASDS) with therapeutic serum concentrations as per the International League Against Epilepsy (ILAE) Commission on Therapeutic Strategies.
- Apart from epilepsy, the participant should be medically and neurologically stable.
- 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 has been informed of his or her eligibility for resective surgery as a potential alternative to receiving, as standard of care, the VNS device that is required for participation in this study, if such surgery is a reasonable option.
Who cannot join
- Cohort 1a (p-VNS): Exclusion Criteria for Participants With Major Depressive Disorder That Have a Previously Implanted VNS Device
- 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.
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- 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.
- Participant currently receives treatment with another investigational device or investigational drug other than the REVEAL study, or has participated in another drug or device trial within the preceding 30 days before enrollment.
- Participant is not able or willing to use their dominant arm, or either upper arm circumference is greater than 50 cm.
- Participant does not speak English.
- Any other clinical reasons deemed by the investigators of the study in which the participant would not be an appropriate candidate for the study, such as peripheral vascular disease, Raynaud's phenomenon, orthostatic hypotension (OH), postural orthostatic tachycardia syndrome (POTS), uncontrolled obstructive sleep apnea (OSA), chronic obstructive pulmonary disease (COPD), or uncontrolled diabetes.
- Cohort 1b (n-VNS): Exclusion Criteria for Participants With Major Depressive Disorder That Will Receive a Newly Implanted VNS Device
- Participant has a prior implantable stimulation device.
- 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.
- Participant currently receives treatment with another investigational device or investigational drug other than the REVEAL study, or has participated in another drug or device trial within the preceding 30 days before enrollment.
- Participant with vocal cord paralysis.
- Participant is not able or willing to use their dominant arm, or either upper arm circumference is greater than 50 cm.
- Participant does not speak English.
- Any other clinical reasons deemed by the investigators of the study in which the participant would not be an appropriate candidate for the study, such as peripheral vascular disease, Raynaud's phenomenon, orthostatic hypotension (OH), postural orthostatic tachycardia syndrome (POTS), uncontrolled obstructive sleep apnea (OSA), chronic obstructive pulmonary disease (COPD), or uncontrolled diabetes.
- Cohort 2a (p-VNS): Exclusion Criteria for Participants With Drug Resistant Epilepsy That Have a Previously Implanted VNS Device
- Participant has demonstrable benefit from implanted VNS device in terms of epilepsy (seizure frequency or seizure severity) or epilepsy comorbidity (mood, cognition, or quality of life), with seizure freedom or clinical benefit.
- Participant has a prior implantable stimulation device, other than a VNS device for the clinical indication of refractory focal Epilepsy.
- Participant currently uses or is expected during the study to use short-wave diathermy, microwave, diathermy, or therapeutic ultrasound diathermy.
- Participant has been hospitalized for a psychiatric condition within the preceding 6 months or has had a history of psychosis within the preceding two years (excluding postictal psychosis).
- Participant has experienced unprovoked status epilepticus in the preceding year.
- Participant has a diagnosis of Substance Use Disorder as defined by DSM-5 without sustained remission of 12 months or longer.
- Participant currently receives treatment with another investigational device or investigational drug other than the REVEAL study, or has participated in another drug or device trial within the preceding 30 days before enrollment.
- Participant is not able or willing to use their dominant arm, or either upper arm circumference is greater than 50 cm.
- Participant does not speak English.
- Any other clinical reasons deemed by the investigators of the study in which the participant would not be an appropriate candidate for the study, such as peripheral vascular disease, Raynaud's phenomenon, orthostatic hypotension (OH), postural orthostatic tachycardia syndrome (POTS), uncontrolled obstructive sleep apnea (OSA), chronic obstructive pulmonary disease (COPD), or uncontrolled diabetes.
- Cohort 2b (n-VNS): Exclusion Criteria for Participants With Drug Resistant Epilepsy That Will Receive a Newly Implanted VNS Device
- Participant has a prior implantable stimulation device.
- Participant currently uses or is expected during the study to use short-wave diathermy, microwave, diathermy, or therapeutic ultrasound diathermy.
- Participant has been hospitalized for a psychiatric condition within the preceding 6 months or has had a history of psychosis within the preceding two years (excluding postictal psychosis).
- Participant has experienced unprovoked status epilepticus in the preceding year.
- Participant has a diagnosis of Substance Use Disorder as defined by DSM-5 without sustained remission of 12 months or longer.
- Participant currently receives treatment with another investigational device or investigational drug other than the REVEAL study, or has participated in another drug or device trial within the preceding 30 days before enrollment.
- Participant with vocal cord paralysis.
- Participant is not able or willing to use their dominant arm, or either upper arm circumference is greater than 50 cm.
- Participant does not speak English.
- Any other clinical reasons deemed by the investigators of the study in which the participant would not be an appropriate candidate for the study, such as peripheral vascular disease, Raynaud's phenomenon, orthostatic hypotension (OH), postural orthostatic tachycardia syndrome (POTS), uncontrolled obstructive sleep apnea (OSA), chronic obstructive pulmonary disease (COPD), or uncontrolled diabetes.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States5 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
Alivation Research, LLC
Lincoln, Nebraska, 68526
University of Minnesota
Minneapolis, Minnesota, 55414
Washington University in St. Louis
St Louis, Missouri, 63110
Stanford University
Stanford, California, 54304
Australia2 sites
Alfred Health
Melbourne, Victoria, 3004
99 Commercial Road
Prahan, Victoria, 3182
About this study
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
- Epilepsy, Depressive Disorder
- Being tested
- Vagus nerve stimulation device: acute and chronic administration of investigational vagus nerve stimulation parameters
- Medical subject headings
- Epilepsy, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus nerve stimulation device: acute and chronic administration of investigational vagus nerve stimulation parametersDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Order 1 assignment | Experimental | individuals 18 years of age and older who are implanted with a VNS device (standard of care), which consists of patients who have been diagnosed with drug resistant epilepsy or major depressive disorder.
Frequency order: F1=1Hz, F2=10Hz, F3=30Hz, period 1,2 and 3 respectively Receives: Device: Vagus nerve stimulation device: acute and chronic administration of investigational vagus nerve stimulation parameters |
| Order 2 assignment | Experimental | individuals 18 years of age and older who are implanted with a VNS device (standard of care), which consists of patients who have been diagnosed with drug resistant epilepsy or major depressive disorder.
Frequency order: F2=10Hz, F3=30Hz, F1=1Hz, period 1,2 and 3 respectively Receives: Device: Vagus nerve stimulation device: acute and chronic administration of investigational vagus nerve stimulation parameters |
| Order 3 assignment | Experimental | individuals 18 years of age and older who are implanted with a VNS device (standard of care), which consists of patients who have been diagnosed with drug resistant epilepsy or major depressive disorder.
Frequency order: F3=30Hz, F1=1Hz, F2=10Hz, period 1,2 and 3 respectively Receives: Device: Vagus nerve stimulation device: acute and chronic administration of investigational vagus nerve stimulation parameters |
| Order 4 assignment | Experimental | individuals 18 years of age and older who are implanted with a VNS device (standard of care), which consists of patients who have been diagnosed with drug resistant epilepsy or major depressive disorder.
Frequency order: F1=1Hz, F3=30Hz, F2=10Hz, period 1,2 and 3 respectively Receives: Device: Vagus nerve stimulation device: acute and chronic administration of investigational vagus nerve stimulation parameters |
| Order 5 assignment | Experimental | individuals 18 years of age and older who are implanted with a VNS device (standard of care), which consists of patients who have been diagnosed with drug resistant epilepsy or major depressive disorder.
Frequency order: F2=10Hz, F1=1Hz, F3=30Hz, period 1,2 and 3 respectively Receives: Device: Vagus nerve stimulation device: acute and chronic administration of investigational vagus nerve stimulation parameters |
| Order 6 assignment | Experimental | individuals 18 years of age and older who are implanted with a VNS device (standard of care), which consists of patients who have been diagnosed with drug resistant epilepsy or major depressive disorder.
Frequency order: F3=30Hz, F2=10Hz, F1=1Hz, period 1,2 and 3 respectively Receives: Device: Vagus nerve stimulation device: acute and chronic administration of investigational vagus nerve stimulation parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Muscle Sympathetic Nerve Burst Incidence with Vagus nerve stimulation
Changes in muscle sympathetic nerve activity burst incidence (bursts/100 heart beats) measured using microneurography of the fibular nerve in response to various vagus nerve stimulation parameters delivered acutely before and after 12 weeks of chronic vagus nerve stimulation.
Measured: baseline and 12 weeks
Change in Muscle Sympathetic Nerve Burst Frequency with Vagus nerve stimulation
Changes in muscle sympathetic nerve activity burst frequency (bursts/min) measured using microneurography of the fibular nerve in response to various vagus nerve stimulation parameters delivered acutely before and after 12 weeks of chronic vagus nerve stimulation.
Measured: baseline and 12 weeks
Change in Muscle Sympathetic Nerve Burst Area with Vagus nerve stimulation
Changes in muscle sympathetic nerve activity burst area (arbitrary units/min) measured using microneurography of the fibular nerve in response to various vagus nerve stimulation parameters delivered acutely before and after 12 weeks of chronic vagus nerve stimulation
Measured: baseline and 12 weeks
Effect of Vagus nerve stimulation on Isometric Hand Grip-mediated changes in Heart Rate
The effect Vagus nerve stimulation has on changes in heart rate (bpm) elicited by the isometric hand grip exercise, measured using electrocardiography
Measured: baseline and 12 weeks
Effect of Vagus nerve stimulation on Isometric Hand Grip-mediated changes in Blood pressure
The effect Vagus nerve stimulation has on changes in systolic, diastolic, and mean arterial blood pressure (mmHg) elicited by the isometric hand grip exercise, measured using finger cuff.
Measured: baseline and 12 weeks
Effect of Vagus nerve stimulation on Isometric Hand Grip-mediated changes in Muscle Sympathetic Nerve Activity (MSNA)
The effect Vagus nerve stimulation has on changes in muscle sympathetic nerve activity elicited by the isometric hand grip exercise, measured using microneurography of the fibular nerve
Measured: baseline and 12 weeks
Effect of Vagus nerve stimulation on Post-exercise circulatory occlusion-mediated change in Heart Rate
The effect Vagus nerve stimulation has on changes in heart rate (bpm) elicited by post-exercise circulatory occlusion following the isometric hand grip exercise, measured using electrocardiography.
Measured: baseline and 12 weeks
Effect of Vagus nerve stimulation on Post-exercise circulatory occlusion-mediated change in Blood pressure
The effect Vagus nerve stimulation has on changes in systolic, diastolic, and mean arterial blood pressure (mmHg) elicited by the post-exercise circulatory occlusion following the isometric hand grip exercise, measured using finger cuff
Measured: baseline and 12 weeks
Effect of Vagus nerve stimulation on Post-exercise circulatory occlusion-mediated change in Muscle Sympathetic Nerve Activity (MSNA)
The effect Vagus nerve stimulation has on changes in muscle sympathetic nerve activity elicited by the post-exercise circulatory occlusion following the isometric hand grip exercise, measured using microneurography of the fibular nerve.
Measured: baseline and 12 weeks
Effect of Vagus nerve stimulation on Head up tilt test-mediated change in Heart Rate
The effect Vagus nerve stimulation has on changes in heart rate (bpm) elicited by a passive head-up tilt test, measured using electrocardiography
Measured: baseline and 12 weeks
Effect of Vagus nerve stimulation on Head up tilt test-mediated change in Blood pressure
The effect Vagus nerve stimulation has on changes in systolic, diastolic, and mean arterial blood pressure (mmHg) elicited by a passive head-up tilt test, measured using finger cuff.
Measured: baseline and 12 weeks
Effect of Vagus nerve stimulation on Head up tilt test-mediated change in Muscle Sympathetic Nerve Activity (MSNA)
The effect Vagus nerve stimulation has on changes in muscle sympathetic nerve activity elicited by a passive head-up tilt test, measured using microneurography of the fibular nerve
Measured: baseline and 12 weeks
Effect of Vagus nerve stimulation on cardiac dimensions
The effect of Vagus nerve stimulation on standard measurements of cardiac dimensions (cm, mL) measured using echocardiography
Measured: baseline and 12 weeks
Effect of Vagus nerve stimulation on cardiac ejection fraction
The effect of Vagus nerve stimulation on standard measurements of cardiac ejection fraction (%) measured using echocardiography.
Measured: baseline and 12 weeks
Effect of Vagus nerve stimulation on cardiac blood flow
The effect of Vagus nerve stimulation on standard measurements of cardiac blood flow (cm/sec) measured using echocardiography and Doppler.
Measured: baseline and 12 weeks
Effect of Vagus nerve stimulation on ambulatory systolic blood pressure
The effect of Vagus nerve stimulation on ambulatory systolic blood pressure (mmHg) measured using an ambulatory blood pressure monitor at-home over a 24-hour period.
Measured: 12 weeks
Effect of Vagus nerve stimulation on ambulatory diastolic blood pressure
The effect of Vagus nerve stimulation on ambulatory diastolic blood pressure (mmHg) measured using an ambulatory blood pressure monitor at-home over a 24-hour period.
Measured: 12 weeks
Effect of Vagus nerve stimulation on ambulatory heart rate
The effect of Vagus nerve stimulation on ambulatory heart rate (bpm) measured using an ambulatory electrocardiography device at-home over a 24-hour period
Measured: 12 weeks
Effect of Vagus nerve stimulation on ambulatory heart rate while in sinus rhythm
The effect of Vagus nerve stimulation on ambulatory heart rate while in sinus rhythm (bpm) measured using an ambulatory electrocardiography device at-home over a 24-hour period.
Measured: 12 weeks
Effect of Vagus nerve stimulation on supraventricular ectopy episodes
The effect of Vagus nerve stimulation on supraventricular ectopy episodes (count) measured using an ambulatory electrocardiography device at-home over a 24-hour period.
Measured: 12 weeks
Effect of Vagus nerve stimulation on ventricular ectopy episodes
The effect of Vagus nerve stimulation on ventricular ectopy episodes (count) measured using an ambulatory electrocardiography device at-home over a 24-hour period.
Measured: 12 weeks
Effect of Vagus nerve stimulation on number of supraventricular tachycardia episodes
The effect of Vagus nerve stimulation on the number of distinct supraventricular tachycardia episodes (count) measured using an ambulatory electrocardiography device at-home over a 24-hour period.
Measured: 12 weeks
Effect of Vagus nerve stimulation on duration of supraventricular tachycardia episodes
The effect of Vagus nerve stimulation on the duration of supraventricular tachycardia episodes (min) measured using an ambulatory electrocardiography device at-home over a 24-hour period.
Measured: 12 weeks
Effect of Vagus nerve stimulation on heart rate during supraventricular tachycardia episodes
The effect of Vagus nerve stimulation on heart rate during supraventricular tachycardia episodes (bpm) measured using an ambulatory electrocardiography device at-home over a 24-hour period.
Measured: 12 weeks
Effect of Vagus nerve stimulation on number of ventricular tachycardia episodes
The effect of Vagus nerve stimulation on the number of distinct ventricular tachycardia episodes (count) measured using an ambulatory electrocardiography device at-home over a 24-hour period.
Measured: 12 weeks
Effect of Vagus nerve stimulation on duration of ventricular tachycardia episodes
The effect of Vagus nerve stimulation on the duration of ventricular tachycardia episodes (min) measured using an ambulatory electrocardiography device at-home over a 24-hour period.
Measured: 12 weeks
Effect of Vagus nerve stimulation on heart rate during ventricular tachycardia episodes
The effect of Vagus nerve stimulation on heart rate during ventricular tachycardia episodes (bpm) measured using an ambulatory electrocardiography device at-home over a 24-hour period.
Measured: 12 weeks
Effect of Vagus nerve stimulation on number of atrial fibrillation episodes
The effect of Vagus nerve stimulation on the number of atrial fibrillation episodes (count) measured using an ambulatory electrocardiography device at-home over a 24-hour period
Measured: 12 weeks
Effect of Vagus nerve stimulation on heart rate during atrial fibrillation episodes
The effect of Vagus nerve stimulation on heart rate during atrial fibrillation episodes (bpm) measured using an ambulatory electrocardiography device at-home over a 24-hour period.
Measured: 12 weeks
Effect of Vagus nerve stimulation on duration atrial fibrillation episodes
The effect of Vagus nerve stimulation on duration of atrial fibrillation episodes (minutes) measured using an ambulatory electrocardiography device at-home over a 24-hour period.
Measured: 12 weeks
Effect of Vagus nerve stimulation on number of atrial flutter episodes
The effect of Vagus nerve stimulation on the number of atrial flutter episodes (count) measured using an ambulatory electrocardiography device at-home over a 24-hour period.
Measured: 12 weeks
Effect of Vagus nerve stimulation on heart rate during atrial flutter episodes
The effect of Vagus nerve stimulation on heart rate during atrial flutter episodes (bpm) measured using an ambulatory electrocardiography device at-home over a 24-hour period
Measured: 12 weeks
Effect of Vagus nerve stimulation on duration of atrial flutter episodes
The effect of Vagus nerve stimulation on the duration of atrial flutter episodes (minutes) measured using an ambulatory electrocardiography device at-home over a 24-hour period.
Measured: 12 weeks
Effect of Vagus nerve stimulation on 2nd degree AV block, Mobitz II
The effect of Vagus nerve stimulation on 2nd degree AV block, Mobitz II occurrence, measured using an ambulatory electrocardiography device at-home over a 24-hour period.
Measured: 12 weeks
Effect of Vagus nerve stimulation on changes in inflammatory/autoimmune biomarkers
Evaluate the change in inflammatory/autoimmune biomarkers before, during, and after 12 weeks of chronic Vagus nerve stimulation using ELISA and CyTOF
Measured: 12 weeks
Effect of Vagus nerve stimulation on changes in metabolites
Evaluate the change in metabolites before, during, and after 12 weeks of chronic Vagus nerve stimulation using Biocrates MxP Quant 500
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start15 Dec 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- For all participants, study interventions will occur primarily at two visits scheduled 12 weeks apart at the applicable study sites (Visit 1 and Visit 2). Within Visit 1, the CSP is a cross-over design to compare the 3 frequency parameters at a set duty cycle; each participant will receive each frequency in a randomized order and this order will be repeated at Visit 2. Visit 1 and Visit 2 together are a cross-over design to compare the 2 duty cycles; each participant will receive one duty cycle at Visit 1 and the other duty cycle at Visit 2 in a randomized order.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Osborn, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143293
- Sponsor's protocol ID
- SURG-2023-31213
- Status last verified
- Sep 2026
- First submitted
- 27 Oct 2023
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESEARCH EVALUATING VAGAL EXCITATION AND ANATOMICAL LINKS
- ClinicalTrials.gov ID
- NCT06143293
- Acronym / sponsor ID
- SURG-2023-31213
- Conditions
- Epilepsy, Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
- Model description
- For all participants, study interventions will occur primarily at two visits scheduled 12 weeks apart at the applicable study sites (Visit 1 and Visit 2). Within Visit 1, the CSP is a cross-over design to compare the 3 frequency parameters at a set duty cycle; each participant will receive each frequency in a randomized order and this order will be repeated at Visit 2. Visit 1 and Visit 2 together are a cross-over design to compare the 2 duty cycles; each participant will receive one duty cycle at Visit 1 and the other duty cycle at Visit 2 in a randomized order.
| Arm | Type | Receives |
|---|---|---|
| Order 1 assignment | Experimental | Device: Vagus nerve stimulation device: acute and chronic administration of investigational vagus nerve stimulation parametersindividuals 18 years of age and older who are implanted with a VNS device (standard of care), which consists of patients who have been diagnosed with drug resistant epilepsy or major depressive disorder. Frequency order: F1=1Hz, F2=10Hz, F3=30Hz, period 1,2 and 3 respectively |
| Order 2 assignment | Experimental | Device: Vagus nerve stimulation device: acute and chronic administration of investigational vagus nerve stimulation parametersindividuals 18 years of age and older who are implanted with a VNS device (standard of care), which consists of patients who have been diagnosed with drug resistant epilepsy or major depressive disorder. Frequency order: F2=10Hz, F3=30Hz, F1=1Hz, period 1,2 and 3 respectively |
| Order 3 assignment | Experimental | Device: Vagus nerve stimulation device: acute and chronic administration of investigational vagus nerve stimulation parametersindividuals 18 years of age and older who are implanted with a VNS device (standard of care), which consists of patients who have been diagnosed with drug resistant epilepsy or major depressive disorder. Frequency order: F3=30Hz, F1=1Hz, F2=10Hz, period 1,2 and 3 respectively |
| Order 4 assignment | Experimental | Device: Vagus nerve stimulation device: acute and chronic administration of investigational vagus nerve stimulation parametersindividuals 18 years of age and older who are implanted with a VNS device (standard of care), which consists of patients who have been diagnosed with drug resistant epilepsy or major depressive disorder. Frequency order: F1=1Hz, F3=30Hz, F2=10Hz, period 1,2 and 3 respectively |
| Order 5 assignment | Experimental | Device: Vagus nerve stimulation device: acute and chronic administration of investigational vagus nerve stimulation parametersindividuals 18 years of age and older who are implanted with a VNS device (standard of care), which consists of patients who have been diagnosed with drug resistant epilepsy or major depressive disorder. Frequency order: F2=10Hz, F1=1Hz, F3=30Hz, period 1,2 and 3 respectively |
| Order 6 assignment | Experimental | Device: Vagus nerve stimulation device: acute and chronic administration of investigational vagus nerve stimulation parametersindividuals 18 years of age and older who are implanted with a VNS device (standard of care), which consists of patients who have been diagnosed with drug resistant epilepsy or major depressive disorder. Frequency order: F3=30Hz, F2=10Hz, F1=1Hz, period 1,2 and 3 respectively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (38 listed)
- 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).
Key exclusion criteria (53 listed)
- Cohort 1a (p-VNS): Exclusion Criteria for Participants With Major Depressive Disorder That Have a Previously Implanted VNS Device
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vagus nerve stimulation device: acute and chronic administration of investigational vagus nerve stimulation parametersDuty 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. | Device | Order 1 assignment, Order 2 assignment, Order 3 assignment, Order 4 assignment, Order 5 assignment, Order 6 assignment |
Primary outcome
Change in Muscle Sympathetic Nerve Burst Incidence with Vagus nerve stimulation
Time frame: baseline and 12 weeks
Changes in muscle sympathetic nerve activity burst incidence (bursts/100 heart beats) measured using microneurography of the fibular nerve in response to various vagus nerve stimulation parameters delivered acutely before and after 12 weeks of chronic vagus nerve stimulation.
Change in Muscle Sympathetic Nerve Burst Frequency with Vagus nerve stimulation
Time frame: baseline and 12 weeks
Changes in muscle sympathetic nerve activity burst frequency (bursts/min) measured using microneurography of the fibular nerve in response to various vagus nerve stimulation parameters delivered acutely before and after 12 weeks of chronic vagus nerve stimulation.
Change in Muscle Sympathetic Nerve Burst Area with Vagus nerve stimulation
Time frame: baseline and 12 weeks
Changes in muscle sympathetic nerve activity burst area (arbitrary units/min) measured using microneurography of the fibular nerve in response to various vagus nerve stimulation parameters delivered acutely before and after 12 weeks of chronic vagus nerve stimulation
Effect of Vagus nerve stimulation on Isometric Hand Grip-mediated changes in Heart Rate
Time frame: baseline and 12 weeks
The effect Vagus nerve stimulation has on changes in heart rate (bpm) elicited by the isometric hand grip exercise, measured using electrocardiography
Effect of Vagus nerve stimulation on Isometric Hand Grip-mediated changes in Blood pressure
Time frame: baseline and 12 weeks
The effect Vagus nerve stimulation has on changes in systolic, diastolic, and mean arterial blood pressure (mmHg) elicited by the isometric hand grip exercise, measured using finger cuff.
Effect of Vagus nerve stimulation on Isometric Hand Grip-mediated changes in Muscle Sympathetic Nerve Activity (MSNA)
Time frame: baseline and 12 weeks
The effect Vagus nerve stimulation has on changes in muscle sympathetic nerve activity elicited by the isometric hand grip exercise, measured using microneurography of the fibular nerve
Effect of Vagus nerve stimulation on Post-exercise circulatory occlusion-mediated change in Heart Rate
Time frame: baseline and 12 weeks
The effect Vagus nerve stimulation has on changes in heart rate (bpm) elicited by post-exercise circulatory occlusion following the isometric hand grip exercise, measured using electrocardiography.
Effect of Vagus nerve stimulation on Post-exercise circulatory occlusion-mediated change in Blood pressure
Time frame: baseline and 12 weeks
The effect Vagus nerve stimulation has on changes in systolic, diastolic, and mean arterial blood pressure (mmHg) elicited by the post-exercise circulatory occlusion following the isometric hand grip exercise, measured using finger cuff
Effect of Vagus nerve stimulation on Post-exercise circulatory occlusion-mediated change in Muscle Sympathetic Nerve Activity (MSNA)
Time frame: baseline and 12 weeks
The effect Vagus nerve stimulation has on changes in muscle sympathetic nerve activity elicited by the post-exercise circulatory occlusion following the isometric hand grip exercise, measured using microneurography of the fibular nerve.
Effect of Vagus nerve stimulation on Head up tilt test-mediated change in Heart Rate
Time frame: baseline and 12 weeks
The effect Vagus nerve stimulation has on changes in heart rate (bpm) elicited by a passive head-up tilt test, measured using electrocardiography
Effect of Vagus nerve stimulation on Head up tilt test-mediated change in Blood pressure
Time frame: baseline and 12 weeks
The effect Vagus nerve stimulation has on changes in systolic, diastolic, and mean arterial blood pressure (mmHg) elicited by a passive head-up tilt test, measured using finger cuff.
Effect of Vagus nerve stimulation on Head up tilt test-mediated change in Muscle Sympathetic Nerve Activity (MSNA)
Time frame: baseline and 12 weeks
The effect Vagus nerve stimulation has on changes in muscle sympathetic nerve activity elicited by a passive head-up tilt test, measured using microneurography of the fibular nerve
Effect of Vagus nerve stimulation on cardiac dimensions
Time frame: baseline and 12 weeks
The effect of Vagus nerve stimulation on standard measurements of cardiac dimensions (cm, mL) measured using echocardiography
Effect of Vagus nerve stimulation on cardiac ejection fraction
Time frame: baseline and 12 weeks
The effect of Vagus nerve stimulation on standard measurements of cardiac ejection fraction (%) measured using echocardiography.
Effect of Vagus nerve stimulation on cardiac blood flow
Time frame: baseline and 12 weeks
The effect of Vagus nerve stimulation on standard measurements of cardiac blood flow (cm/sec) measured using echocardiography and Doppler.
Effect of Vagus nerve stimulation on ambulatory systolic blood pressure
Time frame: 12 weeks
The effect of Vagus nerve stimulation on ambulatory systolic blood pressure (mmHg) measured using an ambulatory blood pressure monitor at-home over a 24-hour period.
Effect of Vagus nerve stimulation on ambulatory diastolic blood pressure
Time frame: 12 weeks
The effect of Vagus nerve stimulation on ambulatory diastolic blood pressure (mmHg) measured using an ambulatory blood pressure monitor at-home over a 24-hour period.
Effect of Vagus nerve stimulation on ambulatory heart rate
Time frame: 12 weeks
The effect of Vagus nerve stimulation on ambulatory heart rate (bpm) measured using an ambulatory electrocardiography device at-home over a 24-hour period
Effect of Vagus nerve stimulation on ambulatory heart rate while in sinus rhythm
Time frame: 12 weeks
The effect of Vagus nerve stimulation on ambulatory heart rate while in sinus rhythm (bpm) measured using an ambulatory electrocardiography device at-home over a 24-hour period.
Effect of Vagus nerve stimulation on supraventricular ectopy episodes
Time frame: 12 weeks
The effect of Vagus nerve stimulation on supraventricular ectopy episodes (count) measured using an ambulatory electrocardiography device at-home over a 24-hour period.
Effect of Vagus nerve stimulation on ventricular ectopy episodes
Time frame: 12 weeks
The effect of Vagus nerve stimulation on ventricular ectopy episodes (count) measured using an ambulatory electrocardiography device at-home over a 24-hour period.
Effect of Vagus nerve stimulation on number of supraventricular tachycardia episodes
Time frame: 12 weeks
The effect of Vagus nerve stimulation on the number of distinct supraventricular tachycardia episodes (count) measured using an ambulatory electrocardiography device at-home over a 24-hour period.
Effect of Vagus nerve stimulation on duration of supraventricular tachycardia episodes
Time frame: 12 weeks
The effect of Vagus nerve stimulation on the duration of supraventricular tachycardia episodes (min) measured using an ambulatory electrocardiography device at-home over a 24-hour period.
Effect of Vagus nerve stimulation on heart rate during supraventricular tachycardia episodes
Time frame: 12 weeks
The effect of Vagus nerve stimulation on heart rate during supraventricular tachycardia episodes (bpm) measured using an ambulatory electrocardiography device at-home over a 24-hour period.
Effect of Vagus nerve stimulation on number of ventricular tachycardia episodes
Time frame: 12 weeks
The effect of Vagus nerve stimulation on the number of distinct ventricular tachycardia episodes (count) measured using an ambulatory electrocardiography device at-home over a 24-hour period.
Effect of Vagus nerve stimulation on duration of ventricular tachycardia episodes
Time frame: 12 weeks
The effect of Vagus nerve stimulation on the duration of ventricular tachycardia episodes (min) measured using an ambulatory electrocardiography device at-home over a 24-hour period.
Effect of Vagus nerve stimulation on heart rate during ventricular tachycardia episodes
Time frame: 12 weeks
The effect of Vagus nerve stimulation on heart rate during ventricular tachycardia episodes (bpm) measured using an ambulatory electrocardiography device at-home over a 24-hour period.
Effect of Vagus nerve stimulation on number of atrial fibrillation episodes
Time frame: 12 weeks
The effect of Vagus nerve stimulation on the number of atrial fibrillation episodes (count) measured using an ambulatory electrocardiography device at-home over a 24-hour period
Effect of Vagus nerve stimulation on heart rate during atrial fibrillation episodes
Time frame: 12 weeks
The effect of Vagus nerve stimulation on heart rate during atrial fibrillation episodes (bpm) measured using an ambulatory electrocardiography device at-home over a 24-hour period.
Effect of Vagus nerve stimulation on duration atrial fibrillation episodes
Time frame: 12 weeks
The effect of Vagus nerve stimulation on duration of atrial fibrillation episodes (minutes) measured using an ambulatory electrocardiography device at-home over a 24-hour period.
Effect of Vagus nerve stimulation on number of atrial flutter episodes
Time frame: 12 weeks
The effect of Vagus nerve stimulation on the number of atrial flutter episodes (count) measured using an ambulatory electrocardiography device at-home over a 24-hour period.
Effect of Vagus nerve stimulation on heart rate during atrial flutter episodes
Time frame: 12 weeks
The effect of Vagus nerve stimulation on heart rate during atrial flutter episodes (bpm) measured using an ambulatory electrocardiography device at-home over a 24-hour period
Effect of Vagus nerve stimulation on duration of atrial flutter episodes
Time frame: 12 weeks
The effect of Vagus nerve stimulation on the duration of atrial flutter episodes (minutes) measured using an ambulatory electrocardiography device at-home over a 24-hour period.
Effect of Vagus nerve stimulation on 2nd degree AV block, Mobitz II
Time frame: 12 weeks
The effect of Vagus nerve stimulation on 2nd degree AV block, Mobitz II occurrence, measured using an ambulatory electrocardiography device at-home over a 24-hour period.
Effect of Vagus nerve stimulation on changes in inflammatory/autoimmune biomarkers
Time frame: 12 weeks
Evaluate the change in inflammatory/autoimmune biomarkers before, during, and after 12 weeks of chronic Vagus nerve stimulation using ELISA and CyTOF
Effect of Vagus nerve stimulation on changes in metabolites
Time frame: 12 weeks
Evaluate the change in metabolites before, during, and after 12 weeks of chronic Vagus nerve stimulation using Biocrates MxP Quant 500
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Osborn, PhD principal investigator
University of Minnesota
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagus nerve stimulation device: acute and chronic administration of investigational vagus nerve stimulation parameters in people with Epilepsy and Depressive Disorder, run by University of Minnesota at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 38 inclusion and 53 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Muscle Sympathetic Nerve Burst Incidence with Vagus nerve stimulation (time frame: baseline and 12 weeks). The study lists 36 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.