Acute Recording of Stereotyped High-Frequency Oscillations

NCT05439655 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: 23-0088591UH3NS117944-01A1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Epilepsy

Keywords

Neuromodulation; HFO; Epilepsy; Machine Learning; Closed-Loop

Outcome Measures

Primary Outcomes (2)

• Robustness in Data Transmission

  Outcome-1 will quantify the feasibility of robust data recording and transmission with the BIC system in the epilepsy monitoring unit (EMU). The investigators will develop software tools to communicate with the BIC directly from MATLAB and Simulink. The incoming data from the implantable system will be visualized with gHIsys, the high-speed data processing libraries of gTec. At the end of the first year, in the epilepsy monitoring unit (EMU), the investigators will test the feasibility of recoding iEEG data from 2 patients continuously over 24 hours with less than \<5% data loss. The BIC system will not be implanted but used externally to record the neural data. The research team will also test to record iEEG/ECoG data simultaneously with 2 BIC units to be ready for those cases where the number of recording channels are larger than =\>32 and \<=64. At this stage Outcome-1 is only related to the device feasibility (robust data transmission) not health related outcome.

  Over 24 hours within the first year of project

• Feasibility of Detection of Stereotyped HFOs

  Outcome-2 will test the feasibility of capturing stereotyped HFO (sHFO) with the BIC system in the EMU setting. Once the feasibility of robust data transmission as listed in (Outcome-1) is tested, the neural activity will be recorded over 24 hours using the BIC system from 10 patients. The hardware will not be implanted but used externally to record the neural data. Then, the research team will compare whether the sHFO detection and SOZ localization accuracy is significantly different between the BIC and FDA approved amplifier. If the investigators can detect stereotyped HFOs with a rate not less than 75% of FDA approved clinical amplifier and predict the SOZ in 8/10 patients, then the research team will move to the second phase of the project to test Outcome-3. Outcome-2 tests the feasibility of capturing relevant neural events with the external BIC system and compares the recording quality to the FDA approved amplifiers. Outcome-2 does not test any health-related outcome.

  Within the first 3 years of the project

Study Arms (1)

Epilepsy

EXPERIMENTAL

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

Device: Brain Interchange System

Interventions

Brain Interchange System DEVICE

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.

Epilepsy

Eligibility Criteria

• Age: 3 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead
• Baylor College of Medicine: collaborator
• CorTec GmbH: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Baylor College of Medicine

Houston, Texas, 77030-3498, United States

Location

Related Publications (1)

• Ayyoubi AH, Fazli Besheli B, Quach MM, Gavvala JR, Goldman AM, Swamy CP, Bartoli E, Curry DJ, Sheth SA, Francis DJ, Ince NF. Benchmarking signal quality and spatiotemporal distribution of interictal spikes in prolonged human iEEG recordings using CorTec wireless brain interchange. Sci Rep. 2024 Feb 8;14(1):2652. doi: 10.1038/s41598-024-52487-5.

  PMID: 38332136 BACKGROUND

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: In a multi-phase structure, the project will investigate the feasibility of recording the HFOs with the BIC system (Cortec, Germany) and then delivering closed-loop stimulation. In the first year of the study, the feasibility of recording and transmitting iEEG data in robust fashion will be tested. For this 2 subjects will be recruited. In the second and third years, the feasibility of capturing HFOs iEEG data with the implantable system will be tested. For this 10 subjects will be recruited. Therefore, in this multiphase feasibility study, in total 12 subjects will be recruited in a sequential fashion. In each phase less than 10 subjects will be recruited to test device feasibility.

Study Record Dates

• First Submitted: June 19, 2022
• First Posted: June 30, 2022
• Study Start: September 1, 2021
• Primary Completion (Estimated): August 28, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Every 6 months
• Access Criteria: Data Archive for the BRAIN Initiative (DABI) - invasive human neurophysiology (including EEG, ECoG, LFP, single unit)

Locations

US (2)