Brain Interchange System for Epilepsy
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Mayo Clinic
Disqualifiers: Inability to continue recordings
No Placebo Group
Approved in 1 Jurisdiction
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.
12345Eligibility 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.
+1 more
Exclusion Criteria
Subjects will be excluded if their condition makes them unable to continue with recordings.
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: EpilepsyExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo ClinicRochester, MN
University of HoustonHouston, TX
Baylor College of MedicineHouston, TX
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
University of HoustonLead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)Collaborator
Baylor College of MedicineCollaborator
CorTec GmbHCollaborator
References
iEEG-recon: A Fast and Scalable Pipeline for Accurate Reconstruction of Intracranial Electrodes and Implantable Devices. [2023]Collaboration between epilepsy centers is essential to integrate multimodal data for epilepsy research. Scalable tools for rapid and reproducible data analysis facilitate multicenter data integration and harmonization. Clinicians use intracranial EEG (iEEG) in conjunction with non-invasive brain imaging to identify epileptic networks and target therapy for drug-resistant epilepsy cases. Our goal was to promote ongoing and future collaboration by automating the process of "electrode reconstruction," which involves the labeling, registration, and assignment of iEEG electrode coordinates on neuroimaging. These tasks are still performed manually in many epilepsy centers. We developed a standalone, modular pipeline that performs electrode reconstruction. We demonstrate our tool's compatibility with clinical and research workflows and its scalability on cloud platforms.
SYLVIUS: A multimodal and multidisciplinary platform for epilepsy surgery. [2021]We present SYLVIUS, a software platform intended to facilitate and improve the complex workflow required to diagnose and surgically treat drug-resistant epilepsies. In complex epilepsies, additional invasive information from exploration with stereoencephalography (SEEG) with deep electrodes may be needed, for which the input from different diagnostic methods and clinicians from several specialties is required to ensure diagnostic efficacy and surgical safety. We aim to provide a software platform with optimal data flow among the different stages of epilepsy surgery to provide smooth and integrated decision making.
Harmonization of the pipeline for seizure detection to phenotype post-traumatic epilepsy in a preclinical multicenter study on post-traumatic epileptogenesis. [2020]The Epilepsy Bioinformatics Study for Antiepileptogenic Therapy (EpiBioS4Rx) Centre without walls is an NIH funded multicenter consortium. One of EpiBioS4Rx projects is a preclinical post-traumatic epileptogenesis biomarker study that involves three study sites: The University of Eastern Finland, Monash University (Melbourne) and the University of California Los Angeles. Our objective is to create a platform for evaluating biomarkers and testing new antiepileptogenic treatments for post-traumatic epilepsy (PTE) using the lateral fluid percussion injury (FPI) model in rats. As only 30-50% of rats with severe lateral FPI develop PTE by 6 months post-injury, prolonged video-EEG monitoring is crucial to identify animals with PTE. Our objective is to harmonize the surgical and data collection procedures, equipment, and data analysis for chronic EEG recording in order to phenotype PTE in this rat model across the three study sites.
Multiple Autologous Bone Marrow-Derived CD271+ Mesenchymal Stem Cell Transplantation Overcomes Drug-Resistant Epilepsy in Children. [2019]There is a need among patients suffering from drug-resistant epilepsy (DRE) for more efficient and less toxic treatments. The objective of the present study was to assess the safety, feasibility, and potential efficacy of autologous bone marrow cell transplantation in pediatric patients with DRE. Two females and two males (11 months to 6 years) were enrolled and underwent a combined therapy consisting of autologous bone marrow nucleated cells (BMNCs) transplantation (intrathecal: 0.5 × 109 ; intravenous: 0.38 × 109 -1.72 × 109 ) followed by four rounds of intrathecal bone marrow mesenchymal stem cells (BMMSCs) transplantation (18.5 × 106 -40 × 106 ) every 3 months. The BMMSCs used were a unique population derived from CD271-positive cells. The neurological evaluation included magnetic resonance imaging, electroencephalography (EEG), and cognitive development assessment. The characteristics of BMMSCs were evaluated. Four intravenous and 20 intrathecal transplantations into the cerebrospinal fluid were performed. There were no adverse events, and the therapy was safe and feasible over 2 years of follow-up. The therapy resulted in neurological and cognitive improvement in all patients, including a reduction in the number of epileptic seizures (from 10 per day to 1 per week) and an absence of status epilepticus episodes (from 4 per week to 0 per week). The number of discharges on the EEG evaluation was decreased, and cognitive improvement was noted with respect to reactions to light and sound, emotions, and motor function. An analysis of the BMMSCs' characteristics revealed the expression of neurotrophic, proangiogenic, and tissue remodeling factors, and the immunomodulatory potential. Our results demonstrate the safety and feasibility of BMNCs and BMMSCs transplantations and the considerable neurological and cognitive improvement in children with DRE. Stem Cells Translational Medicine 2018;7:20-33.
A computer-generated stereotactic "Virtual Subdural Grid" to guide resective epilepsy surgery. [2021]In selected patients undergoing epilepsy surgery, subdural electrode grids play an important role in localizing the epileptogenic zone and identifying eloquent cortex. Determining the relationship of the electrodes to underlying brain architecture traditionally has been difficult. This report describes and validates the use of an original computer-aided method that displays a representation of the electrode positions, based on postimplantation CT or MR findings, coregistered with a 3D-rendered image of the brain, on an image-guided surgery system.