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Brain Monitoring and Stimulation Device for Epilepsy
Study Summary
This trial is testing whether a device that monitors and stimulates the brain can help prevent seizures and improve quality of life for people with epilepsy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- Except for epilepsy, I am neurologically stable.I cannot stop taking my blood thinners for surgery as advised by my doctor.I had surgery for epilepsy that might affect where electrodes can be placed.I have been diagnosed with generalized seizures.I am not pregnant, use birth control, am sterile, or am post-menopausal.I have been hospitalized for a mental health condition or had psychosis in the last two years.I am between 18 and 75 years old.I have had a severe seizure without a clear cause in the last year.My seizure medication has been the same for 3 months, and I've had 6 or more disabling seizures monthly.I experience more than 3 severe seizures a month that disrupt my life.You have a pacemaker, implantable cardiac defibrillator, or another medical device that might interfere with the study device. If you have a vagus nerve stimulator, it needs to be turned off for at least one month or removed before you can participate.I have focal epilepsy with various types of seizures.You have brain wave recordings showing seizures that match your usual seizure type.You cannot have a magnetic resonance imaging (MRI) scan for medical reasons.My body can accommodate the implantation of a Medtronic device close to my skin.You have had a brain MRI for epilepsy in the last two years.My epilepsy originates from one or both sides of my brain's temporal lobes.I have been informed about the option of surgery instead of joining the study.My seizure medication hasn't been stable, or I've had many seizures, or I had a long seizure-free period recently.I can attend all required study visits and phone calls.You have used alcohol, prescription, or illicit drugs excessively in the past two years.I am not suitable for epilepsy surgery due to high risk of memory loss.I have a blood clotting issue due to a condition or medication.I cannot have surgery on my brain.I or my caregiver can clearly count and describe my seizure episodes.My seizures haven't improved with at least two different medications.I have been diagnosed with seizures not caused by epilepsy.
- Group 1: Epilepsy
- 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
To what extent does the Medtronic Summit System, Olympus pose potential harm to patients?
"We rate Medtronic Summit System, Olympus at 1 on a scale from 1 to 3 due to the lack of concrete evidence for safety and effectiveness in this Phase 1 trial."
Does this research project still accept new participants?
"As indicated on clinicaltrials.gov, the recruitment process for this medical trial is currently underway. It was originally published on July 10th 2019 and has been recently updated February 9th 2022."
How many participants have the capacity to join this experimental trial?
"Affirmative. Clinicaltrials.gov hosts data which confirms that this medical study, first posted on July 10th 2019, is actively recruiting patients. This research requires the enrollment of approximately ten individuals from one center."
What are the criteria for joining this trial?
"This clinical trial is enrolling a cohort of 10 individuals experiencing aura within the age range of 18 to 75. To qualify, applicants must meet various criteria including stability in anti-seizure medication dosages for three months prior, at least 6 disabling seizures per month with no more than 30 days seizure-free interval, ability to maintain a seizure diary independently or with help from another person comprehending the task, medically and neurologically stable condition excluding epilepsy, approval from Mayo Clinic Epilepsy Surgery Committee on medical grounds without reference to this protocol, capable of counting distinct stereotypical events as well as having disabling seizures >3 per month that have significant"
Do elderly participants qualify for this clinical trial?
"The parameters for this research initiative state that participants should be between 18 and 75. Separate studies are being conducted with those younger than 18 or above 65 years old, totalling 265 trials in total."
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