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Neurostimulation

DBS Therapy for Epilepsy (EPAS Trial)

N/A
Recruiting
Research Sponsored by MedtronicNeuro
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 or older at the time of enrollment
Focal (partial) onset seizures (based on International League Against Epilepsy (ILAE) 2017 classification) that may or may not evolve to a bilateral tonic-clonic seizure (secondary generalization). The final determination shall be made by the Investigator based on a clinical description of the seizures and previous diagnostic testing that includes, at a minimum, video EEG (inpatient or ambulatory) that captured at least one ictal event
Timeline
Screening 3 weeks
Treatment Varies
Follow Up implant to 36 months post-implant
Awards & highlights

EPAS Trial Summary

This trial will study the long-term effects of a Medtronic DBS device for epilepsy. They will follow participants for 3 years to see how well it works in reducing seizures.

Who is the study for?
This study is for adults with epilepsy who haven't responded to at least 3 antiepileptic drugs. Participants should have an average of 6 or more partial seizures per month and be able to attend scheduled visits and maintain a seizure diary. People can't join if they've had recent severe seizures, are candidates for surgery, have bleeding risks, substance abuse history, need frequent MRIs, or have other electrical implants.Check my eligibility
What is being tested?
The trial is testing the long-term safety and effectiveness of Medtronic's Deep Brain Stimulation (DBS) therapy using Activa™ PC and Percept™ PC systems in reducing seizures over three years in those newly implanted with these devices.See study design
What are the potential side effects?
Potential side effects may include discomfort at the implant site, headache, infection risk at the surgical area, speech problems, numbness or tingling sensations due to nerve stimulation, and unintended brain tissue damage.

EPAS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have partial onset seizures that might become full-body seizures.
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I average 6 or more partial seizures a month, with no 30-day seizure-free periods.
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I can attend all scheduled visits and follow the study rules.
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I can understand and sign the consent form myself or have someone who can do it for me.
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I have tried at least 3 epilepsy drugs without success.

EPAS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~implant to 36 months post-implant
This trial's timeline: 3 weeks for screening, Varies for treatment, and implant to 36 months post-implant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Percentage Reduction in Temporal Lobe Originated Seizure Frequency
Percentage Reduction in Total Disabling Seizure Frequency
Percentage Reduction in Total Seizure Frequency
+1 more

EPAS Trial Design

1Treatment groups
Experimental Treatment
Group I: Active Deep Brain Stimulation (DBS)Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

MedtronicNeuroLead Sponsor
69 Previous Clinical Trials
20,679 Total Patients Enrolled
7 Trials studying Epilepsy
702 Patients Enrolled for Epilepsy

Media Library

Medtronic DBS Therapy (Neurostimulation) Clinical Trial Eligibility Overview. Trial Name: NCT03900468 — N/A
Epilepsy Research Study Groups: Active Deep Brain Stimulation (DBS)
Epilepsy Clinical Trial 2023: Medtronic DBS Therapy Highlights & Side Effects. Trial Name: NCT03900468 — N/A
Medtronic DBS Therapy (Neurostimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03900468 — N/A

Frequently Asked Questions

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

Is this clinical investigation still admitting participants?

"Affirmative, the clinicaltrials.gov site indicates that this research is actively looking for subjects to participate. It was initially posted on March 5th 2020 and revised lastly on September 16th 2022. In total, 140 individuals will be recruited from 20 different localities."

Answered by AI

In what number of healthcare centers is the trial being implemented?

"At this present moment, the clinical trial is being carried out at 20 different sites. These medical centres are located in places such as New Haven, Saint Louis and Phoenix, alongside many other locations. It would be beneficial to select a clinic near you so that your travelling requirements will be minimised should you choose to enrol."

Answered by AI

How many individuals are participating in this research endeavor?

"To execute this clinical trial, MedtronicNeuro requires 140 participants that meet the study's qualification criteria. The medical research will be taking place at Yale School of Medicine in New Haven, Connecticut and Saint Louis University in Saint Louis, Missouri."

Answered by AI
~73 spots leftby Sep 2028