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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new brain device, the Medtronic Summit System, which could help people with epilepsy by sensing brain activity and sending electrical signals to prevent seizures. The device pairs with a handheld gadget that allows patients to interact and track their seizure patterns, moods, and more. The goal is to determine if this setup can improve life for those with tough-to-treat epilepsy, especially those experiencing frequent, disabling seizures that medication cannot control. Individuals who have had epilepsy with significant seizures for over three months but cannot undergo certain surgeries might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to explore innovative treatment options for epilepsy.

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 prior data suggests that this brain monitoring and stimulation device is safe for epilepsy patients?

Research has shown that the Medtronic DBS (Deep Brain Stimulation) System, like the one used in this trial, is safe and effective for people with epilepsy who experience frequent seizures. This device was tested in patients with six or more seizures each month and helped them manage their condition.

Regarding side effects, patients usually tolerate the device well. Most issues are minor and temporary, such as mild discomfort or headaches, which might occur after implantation. Serious problems are rare. The safety data suggests that the device is a reliable option for people with epilepsy seeking new ways to control their seizures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Medtronic Summit System is unique because it combines brain monitoring with targeted stimulation to treat epilepsy, particularly in patients with dominant and bilateral temporal lobe epilepsy. Unlike standard treatments such as anti-seizure medications or surgical interventions, this system offers a non-invasive approach that can precisely target the affected areas of the brain in real-time. Researchers are excited about this device because it not only provides continuous monitoring but also has the potential to reduce seizures by delivering immediate and personalized electrical stimulation, offering hope for improved management of epilepsy with fewer side effects.

What evidence suggests that this device is effective for epilepsy?

Research has shown that the Medtronic Summit System can help manage epilepsy. One study found that patients experienced a 78% reduction in complex partial seizures after using this system's deep brain stimulation. In this trial, participants with dominant temporal lobe epilepsy and bilateral temporal lobe epilepsy will receive treatment with the Medtronic Summit System. The system monitors brain activity and provides targeted stimulation to control seizures. Additionally, the device uses a mobile app to track behavior and physical changes, allowing for treatment adjustments as needed. This method aims to prevent seizures and improve quality of life for people with epilepsy. ^{6 7 8 9 10}

Who Is on the Research Team?

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.

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 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?

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

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03946618

Neurophysiologically Based Brain State Tracking and ... This study will include patients with dominant temporal lobe epilepsy and bilateral temporal lobe epilepsy. The plan is to have 10 patients take part in this ...

2. medtronic.com medtronic.com/me-en/healthcare-professionals/therapies-procedures/neurological/deep-brain-stimulation/indications/epilepsy/clinical-outcomes.html

Deep Brain Stimulation for Epilepsy - Clinical Outcomes After seven years, patients experienced a median 78% reduction in complex partial seizures as compared to baseline. DBS improved seizure severity in years one ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8358117/

Epilepsy Personal Assistant Device—A Mobile Platform for ... A mobile platform for brain state, dense behavioral and physiology tracking and controlling adaptive stimulation.

4. medrxiv.org medrxiv.org/content/10.1101/2024.02.09.24302358v1.full.pdf

Platform for brain network sensing and stimulation with ... Temporal lobe epilepsy (TLE) is a common neurological disease characterized by recurrent focal seizures. These seizures often originate from the mesial temporal ...

5. withpower.com withpower.com/trial/phase-1-epilepsy-6-2019-d7feb

Brain Monitoring and Stimulation Device for Epilepsy The Medtronic Summit System is unique because it combines brain monitoring with responsive stimulation, using an implanted device to track brain activity and ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P960009S219b.pdf

summary of safety and effectiveness data (ssed) The Medtronic DBS System for Epilepsy has demonstrated safety and effectiveness for patients who average six or more seizures per month over ...

7. medtronic.com medtronic.com/en-us/l/patients/treatments-therapies/deep-brain-stimulation-epilepsy/important-safety-information.html

Deep Brain Stimulation for Epilepsy - Important Safety ... The Medtronic DBS System for Epilepsy has demonstrated safety and effectiveness for patients who average six or more seizures per month over the three most ...

8. medtronic.com medtronic.com/in-en/patients/treatments-therapies/deep-brain-stimulation-epilepsy/important-safety-information.html

Deep Brain Stimulation for Epilepsy - Important Safety ... The Medtronic DBS System for Epilepsy has demonstrated safety and effectiveness for patients who average six or more seizures per month over the three most ...

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P960009S478B.pdf

P960009/S478 Summary of Safety and Effectiveness (SSED) The Medtronic DBS System for Epilepsy has demonstrated safety and effectiveness for patients who average six or more seizures per month over the three most ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT04897776

Stimulation of the Thalamus for Arousal Restoral in ... Investigational devices such as the Medtronic Summit RC+S provide a unique opportunity for responsive stimulation of up to four separate brain regions, enabling ...