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VNS Monitoring for Epilepsy

Phase 1

Waitlist Available

Led By Vaughan G Macefield, 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

Medicare covered or equivalent health insurance from a partner country

The participant is greater than or equal to (≥)18 years and is less than or equal to (≤) 40 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 hours

Awards & highlights

Study Summary

This trial will use ultrasound to investigate how different stimulation parameters of VNS devices affect the human vagus nerve. Results will inform the development of neural interfaces for various clinical applications.

Who is the study for?

This trial is for English-speaking adults aged 18-40 with epilepsy who have health insurance and an implanted VNS device. It's not for pregnant individuals, those whose vagus nerve isn't visible on ultrasound, or if the VNS electrodes aren't suitably placed. Smokers must abstain on experiment day, and participants can't have significant carotid artery plaque.Check my eligibility

What is being tested?

The study tests how different stimulation settings of a Vagus Nerve Stimulation (VNS) device affect nerve fibers in the human vagus nerve. Using ultrasound-guided microneurography, researchers record nerve activity to guide future development of neural interfaces for clinical applications.See study design

What are the potential side effects?

While specific side effects are not listed, this type of procedure may cause discomfort at the electrode insertion site, potential temporary voice changes due to vagus nerve stimulation, or mild pain from standing during tilt-table testing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have Medicare or similar health insurance.

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I am between 18 and 40 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 hours for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Discharge variability of cardiac parasympathetic nerve fibers

differences in firing rates of cardiac parasympathetic vagal activity

identify action potential morphology of specific fibers activated by vagal nerve stimulation (VNS)

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: non-VNS participantsExperimental Treatment1 Intervention

participants without implanted VNS devices

Group II: VNSExperimental Treatment1 Intervention

participants with surgically implanted VNS electrodes to treat drug-resistant epilepsy

0 / 2Eligibility criteria met

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of MinnesotaLead Sponsor

1,379 Previous Clinical Trials

1,588,432 Total Patients Enrolled

12 Trials studying Epilepsy

471 Patients Enrolled for Epilepsy

Vaughan G Macefield, PhDPrincipal InvestigatorMonash University

John OsbornPrincipal InvestigatorUniversity of Minnesota

Frequently Asked Questions

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

To what extent does VNS pose a risk to human health?

"The limited evidence gathered for VNS's safety and efficacy leads to a score of 1 on the Power team's scale."

Answered by AI

Is this research protocol restricted to adults below the age of fourty?

"Those between 18 and 40 are eligible to partake in this trial. However, there are 109 clinical studies for minors under the age of 18 and 163 trials intended for adults aged 65 or older."

Answered by AI

Is there still capacity for participants in this experiment?

"According to the clinicaltrials.gov, this particular study is not currently seeking volunteers. It was originally posted on October 1st 2023 and has since been updated for the last time on September 18th 2023. Although it's no longer recruiting participants, there are 253 other relevant trials actively enrolling patients right now."

Answered by AI

Do I qualify to participate in this medical experiment?

"Candidates of this study must possess diagnosed epilepsy and be between 18 to 40 years old. This experiment is aiming to recruit a total of 60 participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Microelectrode Recordings From the Vagus Nerve in Awake Humans

2024. "Microelectrode Recordings From the Vagus Nerve in Awake Humans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06016686.

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