Brain Interchange System for Epilepsy

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

12 Participants Needed

Trial Summary

What is the purpose of this trial?

Overall, this study will investigate the functional utility of stereotyped HFOs by capturing them with a new implantable system (Brain Interchange - BIC of CorTec), which can sample neural data at higher rates \>=1kHz and deliver targeted electrical stimulation to achieve seizure control. In contrast to current closed-loop systems (RNS), which wait for the seizure to start before delivering stimulation, the BIC system will monitor the spatial topography and rate of stereotyped HFOs and deliver targeted stimulation to these HFO generating areas to prevent seizures from occurring. If the outcomes of our research in an acute setting become successful, the investigators will execute a clinical trial and run the developed methods with the implantable BIC system in a chronic ambulatory setting.

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.

How is the Brain Interchange System treatment different from other epilepsy treatments?

The Brain Interchange System is unique because it involves a brain-implantable device that can continuously monitor and modulate brain activity, offering a personalized approach to managing epilepsy, unlike traditional medications or surgeries that do not provide real-time adjustments. ^{1 2 3 4 5}

Eligibility Criteria

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 between 18 and 69 years old.

Exclusion Criteria

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

References

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

iEEG-recon: A Fast and Scalable Pipeline for Accurate Reconstruction of Intracranial Electrodes and Implantable Devices. [2023]

2. Ireland pubmed.ncbi.nlm.nih.gov

SYLVIUS: A multimodal and multidisciplinary platform for epilepsy surgery. [2021]

3. Netherlands 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. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Multiple Autologous Bone Marrow-Derived CD271+ Mesenchymal Stem Cell Transplantation Overcomes Drug-Resistant Epilepsy in Children. [2019]

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

A computer-generated stereotactic "Virtual Subdural Grid" to guide resective epilepsy surgery. [2021]