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DBS Therapy for Epilepsy (EPAS Trial)
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.
EPAS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowEPAS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.EPAS Trial Design
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Who is running the clinical trial?
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- You have seizures so often that you can't keep track of them every day.Within the past year, you have been hospitalized for a mental illness, attempted suicide, or experienced symptoms like hearing or seeing things that are not real, not related to seizures or medication.You have an implanted medical device that uses electrical stimulation, or any metallic implants in your head. If you have a vagus nerve stimulator, study assessment can only start 30 days after it has been turned off. If you have a responsive neurostimulator, study assessment can only start 30 days after it has been turned off.I am not at high risk for bleeding during or after surgery.I am 18 years old or older.You have had problems with drugs or alcohol in the past year.I was diagnosed with non-epileptic seizures in the last year.You have a condition that needs multiple MRI scans.I have partial onset seizures that might become full-body seizures.I average 6 or more partial seizures a month, with no 30-day seizure-free periods.I am able and willing to have surgery to remove a part of my body.I can attend all scheduled visits and follow the study rules.I can understand and sign the consent form myself or have someone who can do it for me.I have not had cancer, except for treated skin cancer, in the last year.You have had a prolonged seizure in the past year.I have tried at least 3 epilepsy drugs without success.I have been diagnosed with generalized onset epilepsy.I have a worsening brain condition.I have a brain condition that is expected to get worse.
- Group 1: Active Deep Brain Stimulation (DBS)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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