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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
Anticipated average of 6 or more focal (partial) onset seizures per month during CMM phase, with no more than 30 consecutive seizure-free days during the CMM phase
Must not have
Risk factors that would put the participant at risk for intraoperative or postoperative bleeding. This includes administration of any antiplatelet or anticoagulant medication in the 7 days prior to surgery, chronic anticoagulant use, chronic aspirin use of greater than 325 mg/day, and any participant with a history of hemorrhagic stroke
Surgical candidate for and willing to undergo resective surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up implant to 36 months post-implant
Awards & highlights
No Placebo-Only Group

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.
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.
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.

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 average 6 or more partial seizures a month, with no 30-day seizure-free periods.
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not at high risk for bleeding during or after surgery.
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I am able and willing to have surgery to remove a part of my body.
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I have not had cancer, except for treated skin cancer, in the last year.
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I have a worsening brain condition.
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I have a brain condition that is expected to get worse.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
71 Previous Clinical Trials
20,995 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
~62 spots leftby Sep 2028
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