5 Participants Needed

Brain Monitoring and Stimulation Device for Epilepsy

KC
Overseen ByKarla Crockett
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
Must be taking: Anti-seizure drugs
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a brain implant and handheld device to monitor and prevent seizures in patients with specific types of epilepsy. The system detects seizures and uses electrical pulses to stop them, learning from the data it collects. There is now experimental and clinical evidence that direct electrical stimulation of the brain can prevent or decrease seizure activity.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, it requires that your anti-seizure medication dosages have been stable for 3 months before enrollment.

Is the Medtronic Summit System safe for use in humans?

The Medtronic Summit System, used in conjunction with the Mayo Epilepsy Personal Assistant Device (EPAD), has undergone extensive testing in animals and is currently in a first-in-human trial for epilepsy. Safety measures, including risk analysis and validation, have been implemented to ensure compliance with regulatory standards.12345

How does the Medtronic Summit System treatment for epilepsy differ from other treatments?

The Medtronic Summit System is unique because it combines brain monitoring with responsive stimulation, using an implanted device to track brain activity and deliver electrical impulses to prevent seizures. This approach allows for real-time adjustments and provides more detailed data on brain activity compared to traditional treatments, which often rely on medication or surgery without continuous monitoring.16789

What data supports the effectiveness of the treatment Medtronic Summit System for epilepsy?

The Medtronic Summit System, used in conjunction with the Mayo Epilepsy Personal Assistant Device (EPAD), is being studied for its ability to monitor brain activity and adjust stimulation to prevent seizures. Similar systems, like the responsive neurostimulation system (RNS), have shown that turning off the stimulation can lead to an increase in seizure frequency, suggesting that these types of treatments can help control seizures.1891011

Who Is on the Research Team?

GA

Gregory Worrell, MD, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

Adults aged 18-75 with focal epilepsy, experiencing more than 3 disabling seizures per month despite stable medication use. Candidates should not be suitable for resective surgery and must be able to maintain a seizure diary and attend regular study visits. Women of childbearing potential must use reliable birth control.

Inclusion Criteria

Except for epilepsy, I am neurologically stable.
I am not pregnant, use birth control, am sterile, or am post-menopausal.
My seizure medication has been the same for 3 months, and I've had 6 or more disabling seizures monthly.
See 16 more

Exclusion Criteria

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.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation and Initial Setup

Implantation of the RC+S system and initial setup for brain state tracking and modulation

4 weeks

Treatment

Continuous 24/7 iEEG monitoring and electrical brain stimulation using the RC+S system

15 months
Biweekly visits for monitoring and adjustments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Medtronic Summit System
Trial Overview The trial is testing an implantable brain device (Medtronic RC+S Summit) paired with a handheld patient assistant device for tracking and potentially preventing seizures through electrical brain stimulation, using machine learning algorithms to predict seizure occurrence.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: EpilepsyExperimental Treatment1 Intervention
Patients with dominant temporal lobe epilepsy and bilateral temporal lobe epilepsy

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

Medtronic

Industry Sponsor

Trials
627
Recruited
767,000+
Geoff Martha profile image

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz profile image

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Published Research Related to This Trial

The Mayo Epilepsy Personal Assistant Device (EPAD) is designed to enhance seizure prediction and management by integrating with the Medtronic Summit RC+STM device for real-time monitoring of brain activity, which could improve the effectiveness of neuromodulation therapy.
The EPAD system is currently undergoing a first-in-human trial involving ten patients with difficult-to-treat epilepsy, following extensive testing on canines, indicating a strong commitment to safety and regulatory compliance in its development.
Epilepsy Personal Assistant Device-A Mobile Platform for Brain State, Dense Behavioral and Physiology Tracking and Controlling Adaptive Stimulation.Pal Attia, T., Crepeau, D., Kremen, V., et al.[2022]
A survey of 70 epilepsy monitoring units revealed that common adverse events include falls (69%), status epilepticus (63%), and postictal psychosis (54%), indicating significant safety concerns in these settings.
Serious but less frequent events such as pneumonia (10%), cardiac arrest (7%), and even death (3%) were reported, emphasizing the need for improved safety protocols in epilepsy monitoring units.
Risk of adverse events on epilepsy monitoring units: a survey of epilepsy professionals.Shafer, PO., Buelow, J., Ficker, DM., et al.[2015]
Serious adverse events (SAEs) during long-term video-electroencephalography monitoring (LTM) occur in about 10% of patients, including severe complications like generalized tonic-clonic seizures, injuries, and even sudden unexpected death in epilepsy (SUDEP).
The risk of SAEs may be increased by the withdrawal of antiepileptic drugs (AEDs), and current EMU practices often do not adhere to recommended guidelines for continuous supervision, highlighting a need for improved organization and staff training in epilepsy monitoring units.
Patients' safety in the epilepsy monitoring unit: time for revising practices.Rheims, S., Ryvlin, P.[2014]

Citations

Epilepsy Personal Assistant Device-A Mobile Platform for Brain State, Dense Behavioral and Physiology Tracking and Controlling Adaptive Stimulation. [2022]
Network system for automated seizure detection and contingent delivery of therapy. [2019]
Preliminary experience with a new system for vagus nerve stimulation for the treatment of refractory focal onset seizures. [2013]
Insights Into the Therapeutic Effect of Responsive Neurostimulation Assessed With Scalp EEG Recording: A Case Report. [2018]
Mesial temporal resection following long-term ambulatory intracranial EEG monitoring with a direct brain-responsive neurostimulation system. [2021]
Risk of adverse events on epilepsy monitoring units: a survey of epilepsy professionals. [2015]
Patients' safety in the epilepsy monitoring unit: time for revising practices. [2014]
Safety in the epilepsy monitoring unit: A retrospective study of 524 consecutive admissions. [2018]
Developing a culture of safety in the epilepsy monitoring unit: a retrospective study of safety outcomes. [2012]
10.United Statespubmed.ncbi.nlm.nih.gov
The use of automated system for EEG analysis and feedback cerebral stimulation to stop epileptiform activity in WAG/Rij rats. [2015]
Critical review of the responsive neurostimulator system for epilepsy. [2021]
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