Acute Stimulation and Modulation of Stereotyped High-Frequency Oscillations

NCT06898138 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: 24-012951UH3NS117944
• Study Type: interventional
• Target: 8
• 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)

• 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

• Feasibility of Delivering Closed-Loop Stimulation

  Outcome-3 will test the feasibility of delivering of closed-loop stimulation with the BIC system. If the detection of sHFO with the BIC system is feasible (Outcome-2), the investigators will start to test the online methods on the previously recorded datasets to isolate sHFOs in streaming iEEG/ECoG. Using the computer in the loop real-time system and the BIC, in the last 2 years, closed-loop stimulation will be delivered. In total 8 patients will be recruited for this particular purpose. Targeted stimulation will be delivered to those channels associated with sHFOs and other areas which are not associated with sHFOs. The research team will test if the device can deliver stimulation to selected channels without any failure. The BIC system will not be implanted but used externally to deliver the stimulation. Outcome-3 does not test whether the system can control the seizures of the patients. It only investigates the feasibility of delivering closed-loop stimulation.

  In the 4th and 5th 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

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

Central Study Contacts

Nuri F Ince, Ph.D.

CONTACT

5072843134; Ince.Nuri@mayo.edu

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

CONTACT

5072847085; Worrell.Gregory@mayo.edu

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 this phase of the project, the feasibility of delivering of closed-loop stimulation with the implantable system will be tested. For this 8 subjects will be recruited. Therefore, in this phase of the study, a total 8 subjects will be recruited in a sequential fashion to test device feasibility.

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 27, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): February 15, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: May 18, 2026

Record last verified: 2026-05

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)