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Vagus Nerve Stimulation for Epilepsy

N/A

Waitlist Available

Led By Warren M Grill, PhD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult epilepsy patients undergoing VNS electrode implantation or implanted pulse generator (IPG) replacement surgery

Neurologically stable aside from epilepsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during procedure (30 minutes)

Awards & highlights

Study Summary

This trialwill test how well stimulating the vagus nerve with a device can activate the nerve and reduce side effects. It'll use adult epilepsy patients already having surgery to implant or replace the device.

Who is the study for?

This trial is for adults with epilepsy who are in good health and neurologically stable, aside from their epilepsy. They must be undergoing surgery to either get a VNS device implanted or have the battery replaced. Participants need to be able to give informed consent but can't join if they have heart conditions that make it risky or another electrical implant besides VNS.Check my eligibility

What is being tested?

The study tests how different settings on a vagus nerve stimulation (VNS) device affect nerve activation and side effects during surgery. It aims to find better ways of setting up these devices by measuring nerve responses, muscle reactions in the neck, and heart rate changes at various stimulation levels.See study design

What are the potential side effects?

Possible side effects include contractions of neck muscles and changes in heart rate when the vagus nerve is stimulated using different parameters within safe clinical limits.

Eligibility Criteria

Inclusion Criteria

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

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I am an adult with epilepsy getting a VNS device implanted or replaced.

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My neurological condition is stable, except for epilepsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during procedure (30 minutes)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during procedure (30 minutes)

This trial's timeline: 3 weeks for screening, Varies for treatment, and during procedure (30 minutes) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

stimulation amplitude threshold

Trial Design

1Treatment groups

Experimental Treatment

Group I: Investigational Stimulation ParametersExperimental Treatment1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,358 Previous Clinical Trials

3,420,039 Total Patients Enrolled

9 Trials studying Epilepsy

31,474 Patients Enrolled for Epilepsy

Warren M Grill, PhDPrincipal InvestigatorDuke University

2 Previous Clinical Trials

198 Total Patients Enrolled

Media Library

Vagus Nerve Stimulation (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05395026 — N/A

Epilepsy Research Study Groups: Investigational Stimulation Parameters

Epilepsy Clinical Trial 2023: Vagus Nerve Stimulation Highlights & Side Effects. Trial Name: NCT05395026 — N/A

Vagus Nerve Stimulation (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05395026 — N/A

Frequently Asked Questions

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

Do applicants for this trial need to meet certain age criteria?

"This research is open for patients of legal age, that being over 18 and under 65."

Answered by AI

Are there still opportunities to become involved in this research endeavor?

"According to the clinicaltrials.gov records, this particular medical trial is not currently enrolling patients. The study was initially posted on December 1st 2022 and its most recent update occurred in November 4th 2022. Unfortunatly, participants are being sought for other trials active at present; a total of 239 studies need volunteers as we speak."

Answered by AI

What are the criteria for eligibility to participate in this trial?

"Those that wish to be considered for this trial must present with aura and adhere to an age range of 18-65 years old. Altogether, the study is looking to enrol eighteen individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Systematic Evaluation of VNS Parameters

2022. "Systematic Evaluation of VNS Parameters". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05395026.

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