Brain Interchange System for Epilepsy

No longer recruiting at 2 trial locations

Overseen By Gregory A Worrell, M.D., Ph.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Inability to continue recordings

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new implantable device called the Brain Interchange System, designed to help people with epilepsy. Unlike current systems, this device detects specific brain signals and delivers a gentle electrical pulse to stop seizures before they start. It targets individuals with medication-resistant epilepsy who are being evaluated for brain monitoring. Participants should have ongoing epilepsy issues despite trying other treatments. The goal is to determine if this device can make living with epilepsy easier by effectively preventing seizures.

As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could transform epilepsy treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Brain Interchange System is safe for epilepsy patients?

Research shows that the Brain Interchange System is undergoing testing to determine its safety for people. In an early study, researchers implanted the system in a person recovering from strokes to gather initial safety information. The main goal was to assess the implant's comfort and functionality.

As this is an early study, the focus remains on identifying any side effects. It is important to note that this phase provides limited safety information. Further research is necessary to fully understand the system's safety. However, this stage is crucial for detecting any major problems early. Always consult medical professionals to discuss concerns and gain a clearer understanding of what to expect. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Brain Interchange System is unique because it offers a new approach for treating drug-resistant epilepsy. Unlike traditional treatments like anti-seizure medications or surgical interventions, this system involves a cutting-edge device that interfaces directly with the brain to monitor and respond to seizure activity. Researchers are excited about its potential to provide real-time, personalized therapy that could significantly reduce seizures and improve quality of life for patients who haven't found relief through existing options. This novel method could revolutionize how epilepsy is managed by targeting the condition more precisely and dynamically than ever before.

What evidence suggests that the Brain Interchange System is effective for epilepsy?

Research has shown that the Brain Interchange System (BIC), which participants in this trial will receive, might help manage epilepsy by targeting specific brain activities linked to seizure onset. By monitoring and stimulating these areas before a seizure begins, the BIC system aims to prevent seizures. Early studies demonstrated that the BIC system can accurately record brain signals and provide timely electrical stimulation. Unlike current systems, it works to prevent seizures before they start, rather than responding afterward. Although direct evidence of its effectiveness for epilepsy is not yet available, the system's design appears promising for controlling seizures. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults and children with hard-to-treat epilepsy, aged between 3 to under 70 years, who are suitable for brain monitoring. It includes women and minorities but excludes those whose condition may interfere with ongoing recordings.

Inclusion Criteria

I have epilepsy that doesn't respond to medication and am approved for brain monitoring.

I am between 3 and 17 years old.

I am a woman or identify as part of a minority group.

Exclusion Criteria

Subjects will be excluded if their condition makes them unable to continue with recordings.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Feasibility Testing

Testing the feasibility of robust data recording and transmission with the BIC system in the epilepsy monitoring unit (EMU).

24 hours

Continuous monitoring

Detection Phase

Testing the feasibility of capturing stereotyped HFOs with the BIC system in the EMU setting.

Within the first 3 years

Stimulation Phase

Delivering targeted electrical stimulation to brain sites associated with stereotyped HFOs using the BIC system.

In the 4th and 5th years

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Brain Interchange System

Trial Overview The study tests a new device called the Brain Interchange System that records brain activity at high rates and delivers targeted stimulation to prevent seizures before they start, unlike current systems that react after seizures begin.

How Is the Trial Designed?

Group I: Epilepsy Experimental Treatment 1 Intervention

patients with drug resistant epilepsy undergoing a surgical evaluation in the epilepsy monitoring unit

Brain Interchange System is already approved in United States for the following indications:

Approved in United States as Brain Interchange System for:

• Stroke rehabilitation
• Seizure control in epilepsy

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

University of Houston

Lead Sponsor

Trials

155

Recruited

48,600+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

CorTec GmbH

Collaborator

Trials

2

Recruited

20+

Published Research Related to This Trial

The SYLVIUS software platform enhances the workflow for diagnosing and surgically treating drug-resistant epilepsies by facilitating seamless data sharing among various medical specialties, which is crucial for ensuring diagnostic efficacy and surgical safety.

In a retrospective evaluation of 19 cases, SYLVIUS enabled modifications to surgical trajectories based on multimodal information, leading to improved surgical planning and integration with robotic systems for interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SYLVIUS: A multimodal and multidisciplinary platform for epilepsy surgery. Higueras-Esteban, A., Delgado-Martínez, I., Serrano, L., et al.[2021]

A new computer-aided method for visualizing subdural electrode positions in epilepsy surgery was validated in 17 patients, showing satisfactory accuracy in all cases.

Quantitative measurements in a subgroup of 5 patients revealed that the mean error for electrode positions was 3.4 mm for CT images and 2.5 mm for MR images, indicating that while MR images were slightly more accurate, CT images were faster to process, enhancing precision in surgical planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A computer-generated stereotactic "Virtual Subdural Grid" to guide resective epilepsy surgery. Morris, K., O'Brien, TJ., Cook, MJ., et al.[2021]

The iEEG-recon pipeline automates the reconstruction of intracranial EEG electrodes on brain MRIs, significantly reducing the time needed for electrode labeling and localization to about 10-20 minutes per case, which enhances efficiency in clinical workflows.

This tool has been validated using data from 132 patients across two epilepsy centers, demonstrating its accuracy and compatibility with existing imaging techniques, making it a valuable resource for improving collaboration in epilepsy research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

iEEG-recon: A Fast and Scalable Pipeline for Accurate Reconstruction of Intracranial Electrodes and Implantable Devices. Lucas, A., Scheid, BH., Pattnaik, AR., et al.[2023]

The EpiBioS4Rx study successfully harmonized surgical and data collection procedures across three research sites, allowing for consistent monitoring of post-traumatic epilepsy (PTE) in rats using a standardized video-EEG protocol.

By implementing rigorous quality control measures, the study demonstrated that all participating centers could reliably identify and phenotype seizures in rats following traumatic brain injury, enhancing the reliability of preclinical research for developing antiepileptogenic therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harmonization of the pipeline for seizure detection to phenotype post-traumatic epilepsy in a preclinical multicenter study on post-traumatic epileptogenesis. Casillas-Espinosa, PM., Andrade, P., Santana-Gomez, C., et al.[2020]

The study involving four pediatric patients with drug-resistant epilepsy showed that autologous bone marrow cell transplantation is safe and feasible, with no adverse events reported over a 2-year follow-up period.

All patients experienced significant neurological and cognitive improvements, including a dramatic reduction in seizure frequency from 10 per day to 1 per week, and the absence of status epilepticus episodes, indicating potential efficacy of this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple Autologous Bone Marrow-Derived CD271+ Mesenchymal Stem Cell Transplantation Overcomes Drug-Resistant Epilepsy in Children. Milczarek, O., Jarocha, D., Starowicz-Filip, A., et al.[2019]

Citations

1. withpower.com withpower.com/trial/phase-epilepsy-2-2026-5d98d

Brain Interchange System for Epilepsy · Info for Participants What data supports the effectiveness of the Brain Interchange System treatment for epilepsy? While there is no direct data on the Brain Interchange System ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9806357/

Toward a fully implantable ecosystem for adaptive ... This article describes initial work toward an ecosystem for adaptive neuromodulation in humans by documenting the experience of implanting ...

3. mayoclinic.elsevierpure.com mayoclinic.elsevierpure.com/en/projects/acute-modulation-of-stereotyped-high-frequency-oscillations-with--2

Acute Modulation of Stereotyped High Frequency ... Project Summary: High frequency oscillations (HFOs) of intracranial EEG (iEEG) have the potential to identify the surgical resection area/seizure onset zone ...

4. nature.com nature.com/articles/s41598-024-52487-5

Benchmarking signal quality and spatiotemporal ... We investigated the feasibility of recording human intracranial EEG (iEEG) using a benchtop version of the Brain Interchange (BIC) unit of CorTec.

5. ieeexplore.ieee.org ieeexplore.ieee.org/iel8/7333/10398877/10679661.pdf

Development and Evaluation of a Real-Time Phase- ... Our findings indicate that the Brain. Interchange and OMNI-BIC platform is capable of reliable administration of phase-triggered stimulation and has the.

6. cortec-neuro.com cortec-neuro.com/applications/brain-stimulation/

Brain Stimulation | CorTec | Thinking ahead The symptoms of these seizures vary ranging from short mental “absences” to the dreaded “grand mal” attacks, accompanied by falls and uncontrolled twitching.

7. insights.citeline.com insights.citeline.com/medtech-insight/business/r-and-d/clinical-trials/cortec-begins-first-human-trial-of-wireless-brain-implant-for-stroke-rehab-5GRLD4I2AVCCLPCAV75UVP6TEA/

CorTec Begins First Human Trial Of Wireless Brain Implant For ... The 52-year-old man, who is recovering from multiple strokes, is participating in a clinical trial to gather initial safety data and evaluate ...

8. 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 ...