Acute Stimulation for the Modulation of Epileptic Events With a Closed-Loop Brain Interchange System in Drug Resistant Epilepsy
Mayo Clinic
Summary
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.
Description
High-frequency oscillations (HFOs) of intracranial EEG (iEEG) have the potential to identify the surgical resection area/seizure onset zone (SOZ) in patients with drug-resistant epilepsy. However, multiple reports indicate that HFOs can be generated not only by epileptic cerebral tissue but also by non-epileptic sites often including eloquent regions such as motor, visual, and language cortices. In this project, the initial evidence of a recurrent waveform pattern is presented that may be sufficient to distinguish pathological HFOs from physiological ones. Specifically, the investigators show…
Eligibility
- Age range
- 3–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients with medically refractory epilepsy, who have been deemed appropriate candidates for intracranial EEG monitoring * Adult men and women (18≤ age \<70 years) * Children (3≤ age \<18 years) * Includes women and minorities Exclusion Criteria: • Subjects will be excluded if their condition makes them unable to continue with recordings.
Interventions
- DeviceBrain Interchange System
The CorTec Brain Interchange (BIC) is an implantable system with sensing and stimulation capability dedicated to promoting brain computer interface and closed-loop neuromodulation research. It is an externally powered implant which can provide neural data to a nearby computing station (communication unit connected to a personal computer) continuously. In return, computing station controls the implant e.g. for generating therapeutic electrical stimulation to the brain. It is expected that BIC will catalyze translational applications of electroceuticals in human subject by making the neural data immediately available as well as permit the investigation of novel closed-loop neuromodulation applications.
Locations (2)
- Mayo ClinicRochester, Minnesota
- Baylor College of MedicineHouston, Texas