Brain Monitoring and Stimulation Device for Epilepsy

Overseen By Karla Crockett

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: Anti-seizure drugs

Must not be taking: Anticoagulants, Aspirin

Disqualifiers: Substance abuse, Psychiatric hospitalization, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 15 months

5 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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. ^{1 2 4 10 11}

Research Team

Gregory Worrell, MD, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

I am between 18 and 75 years old.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Epilepsy Experimental Treatment 1 Intervention

Patients with dominant temporal lobe epilepsy and bilateral temporal lobe epilepsy

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

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' safety in the epilepsy monitoring unit: time for revising practices. Rheims, S., Ryvlin, P.[2014]

In a study of 524 patients admitted to an epilepsy monitoring unit (EMU), adverse events (AEs) occurred in 9.0% of cases, with seizure clusters being the most common type of AE (58.7%).

Patients with more severe epilepsy, a history of temporal lobe epilepsy, and those undergoing presurgical evaluations were at a higher risk for AEs, while those with psychogenic nonepileptic seizures experienced fewer adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety in the epilepsy monitoring unit: A retrospective study of 524 consecutive admissions. Fahoum, F., Omer, N., Kipervasser, S., et al.[2018]

The NeuroPace responsive neurostimulator, recently approved by the FDA, is an implantable device that monitors brain activity and delivers electrical stimulation to reduce seizures in patients with medically refractory epilepsy.

Initial reports indicate that the device is well tolerated and can reduce seizure frequency by about 50% over a 2-year period, providing a promising new treatment option for patients with limited alternatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical review of the responsive neurostimulator system for epilepsy. Thomas, GP., Jobst, BC.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Epilepsy Personal Assistant Device-A Mobile Platform for Brain State, Dense Behavioral and Physiology Tracking and Controlling Adaptive Stimulation. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Network system for automated seizure detection and contingent delivery of therapy. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Preliminary experience with a new system for vagus nerve stimulation for the treatment of refractory focal onset seizures. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Insights Into the Therapeutic Effect of Responsive Neurostimulation Assessed With Scalp EEG Recording: A Case Report. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Mesial temporal resection following long-term ambulatory intracranial EEG monitoring with a direct brain-responsive neurostimulation system. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Risk of adverse events on epilepsy monitoring units: a survey of epilepsy professionals. [2015]

7. England pubmed.ncbi.nlm.nih.gov

Patients' safety in the epilepsy monitoring unit: time for revising practices. [2014]

8. United States pubmed.ncbi.nlm.nih.gov

Safety in the epilepsy monitoring unit: A retrospective study of 524 consecutive admissions. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Developing a culture of safety in the epilepsy monitoring unit: a retrospective study of safety outcomes. [2012]

10. United States pubmed.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]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Critical review of the responsive neurostimulator system for epilepsy. [2021]