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Order 2 assignment for Depression

N/A
Recruiting
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

Study 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.Check my eligibility
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.See study design
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 below
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I have major depression and already have a VNS device implanted.
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I can sign and understand the consent form and HIPAA authorization.
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I have a VNS device implanted for my depression.
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I have been diagnosed with long-term or frequently recurring depression and need VNS therapy.
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I am 18 years old or older.
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I am getting a new VNS device for my major depressive disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 more

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
1,381 Previous Clinical Trials
1,588,831 Total Patients Enrolled
32 Trials studying Depression
5,543 Patients Enrolled for Depression
John Osborn, PhDPrincipal InvestigatorUniversity of Minnesota

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for patients to participate in this study?

"Indeed, according to the details provided on clinicaltrials.gov, this study is currently actively seeking eligible patients. The trial was initially posted for recruitment purposes on December 15th, 2023 and underwent its most recent update on January 28th, 2024."

Answered by AI

What is the upper limit for the number of patients who can participate in this clinical trial?

"Indeed, according to the details provided on clinicaltrials.gov, this trial is currently in the recruitment phase. It was initially posted on December 15th, 2023 and last edited on January 28th, 2024. The study aims to enroll a total of 144 patients from a single site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
RESEARCH EVALUATING VAGAL EXCITATION AND ANATOMICAL LINKS
2023. "RESEARCH EVALUATING VAGAL EXCITATION AND ANATOMICAL LINKS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06143293.
All > Epilepsy > Paid Studies Minneapolis
~96 spots leftby Dec 2025
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