Your session is about to expire
← Back to Search
Vagus Nerve Stimulation for Depression
N/A
Waitlist Available
Led By John Osborn, PhD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Cohort 1a (p-VNS): Inclusion Criteria for Participants With Major Depressive Disorder That Have a Previously Implanted VNS Device
Participant must have the capacity to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare the effects of VNS stimulation on different systems in the body, such as the nervous system, cardiovascular system, immune system, and metabolic system. The effects will be measured using non
Who is the study for?
This trial is for adults over 18 with drug-resistant epilepsy or major depressive disorder who already have a vagus nerve stimulation (VNS) device implanted. They must be able to consent, have stable medication use for two months prior, and possess active health insurance. Women of childbearing potential must agree to use birth control during the study.
What is being tested?
The REVEAL study investigates how different VNS settings affect the body's nerves, heart, immune system, and metabolism in patients with epilepsy or depression. It's not a treatment but aims to understand how efferent versus afferent nerve signals influence organ function based on VNS parameters.
What are the potential side effects?
While specific side effects are not listed here, typical risks of VNS may include voice changes, coughing, tingling sensation in the skin where the device is placed, shortness of breath especially during exercise; discomfort in throat; difficulty swallowing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have major depression and already have a VNS device implanted.
Select...
I can sign and understand the consent form and HIPAA authorization.
Select...
I have a VNS device implanted for my depression.
Select...
I have been diagnosed with long-term or frequently recurring depression and need VNS therapy.
Select...
I am 18 years old or older.
Select...
I am getting a new VNS device for my major depressive disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Muscle Sympathetic Nerve Burst Area with Vagus nerve stimulation
Change in Muscle Sympathetic Nerve Burst Frequency with Vagus nerve stimulation
Change in Muscle Sympathetic Nerve Burst Incidence with Vagus nerve stimulation
+33 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
6Treatment groups
Experimental Treatment
Group I: Order 6 assignmentExperimental Treatment1 Intervention
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
Group II: Order 5 assignmentExperimental Treatment1 Intervention
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
Group III: Order 4 assignmentExperimental Treatment1 Intervention
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
Group IV: Order 3 assignmentExperimental Treatment1 Intervention
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
Group V: Order 2 assignmentExperimental Treatment1 Intervention
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
Group VI: Order 1 assignmentExperimental Treatment1 Intervention
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
Find a Location
Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,439 Previous Clinical Trials
1,621,814 Total Patients Enrolled
34 Trials studying Depression
5,512 Patients Enrolled for Depression
John Osborn, PhDPrincipal InvestigatorUniversity of Minnesota