EpilepsyNCT05439655
Acute Recording of Stereotyped High-Frequency Oscillations
A study testing Brain Interchange System in people with Epilepsy, run by Mayo Clinic at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 64 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Brain Interchange System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2021to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients with medically refractory epilepsy, who have been deemed appropriate candidates for intracranial EEG monitoring
- Adult men and women (18≤ age ≤64 years)
- children (3≤ age <18 years)
- includes women and minorities
Who cannot join
- Subjects will be excluded if their condition makes them unable to continue with recordings.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baylor College of Medicine
Houston, Texas, 77030-3498
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Acute Recording of Stereotyped High-Frequency Oscillations With a Closed-Loop Brain Interchange System in Drug-Resistant Epilepsy
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.
Read the detailed 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 that the SOZ repeatedly generates sets of stereotypical HFOs with similar waveform morphology whereas the events recorded from out of SOZ were irregular. This morphological pattern served as a robust neurobiomarker to isolate SOZ from other brain areas in multiple patients consistently. While these promising preliminary results are in place, the functional utility of stereotyped HFOs in a closed-loop seizure control system remains unknown. As of today, not much is known whether the stereotyped HFOs generated by the SOZ can be detected with an implantable system. If this can be achieved, then HFOs can be strategically translated as a neurobiomarker into closed-loop seizure control applications. The investigators hypothesize that pathologic stereotyped HFOs can be captured with the implantable Brain Interchange (BIC) system of CorTec and spatial topography of these events can be utilized by the implantable system to deliver targeted electrical stimulation to achieve seizure control. Using an acute setup within the epilepsy monitoring unit (EMU), this project will investigate the feasibility of capturing stereotyped HFO events using the new BIC system and compare the detection results to those obtained with the commercially available amplifier (Aim-1). If the first phase (Aim-1) of the study becomes successful, later in the second phase (Aim-2), once again in the EMU, the investigators will deliver targeted electrical stimulation to those brain sites associated with stereotyped HFOs using the BIC.
During the entire study, the BIC system will not be implanted but used externally to assess the neural data through externalized electrodes and then deliver closed-loop stimulation. If the outcomes of the research in an acute setting become successful, the investigators will execute a clinical trial and run our methods with the implanted BIC system in a chronic ambulatory setting.
- Conditions
- Epilepsy
- Being tested
- Brain Interchange System
- Keywords
- Neuromodulation, HFO, Epilepsy, Machine Learning, Closed-Loop
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Interchange SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Epilepsy | Experimental | patients with drug resistant epilepsy undergoing a surgical evaluation in the epilepsy monitoring unit Receives: Device: Brain Interchange System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Packet Loss Rate
Assessed by the percentage of transmitted data packets (a small unit of information that a device sends across a network) that were not successfully received and recorded by the BIC system in the epilepsy monitoring unit.
Measured: Over 24 hours
Percentage of Clinical Amplifier-Detected High Frequency Oscillations (HFOs) Retained in BIC Recordings
The outcome was calculated as the proportion of HFO events detected by the clinical amplifier that were also retained in the BIC recording during the 24-hour EMU recording period. The reported value represents a percentage calculated from the total number of retained HFO events divided by the total number of HFO events detected by the clinical amplifier. Because this outcome measure is an event-based proportion calculated from counts of detected HFOs rather than a participant-level variable measured for each participant, a measure type of Number was used rather than a measure of central tendency.
Measured: Over 24 hours
Accuracy of BIC-Derived High Frequency Oscillations for Localization of the Seizure Onset Zone
Evaluated the ability of BIC-derived HFOs to localize the seizure onset zone during a 24-hour EMU recording.
Measured: Over 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start1 Sep 2021
- Primary completion11 Aug 2025
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine, CorTec GmbH, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Nuri F. Ince, Mayo Clinic
- Investigators
- Nuri F Ince, Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439655
- Sponsor's protocol ID
- 23-008859
- Other IDs
- 1UH3NS117944-01A1
- Status last verified
- Aug 2026
- First submitted
- 19 Jun 2022
- Last updated
- 15 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Intracranial EEG + ECoG recorded from patients with epilepsy will be shared. The electrical signs of neural activity will be collected in the EMU for 24hrs. One stream of data will be digitized at 1kHz with 16bit resolution with the BIC system and the other stream with least a 2 kHz sampling frequency to capture HFOs reaching up to 500Hz. All collected data will be de-identified prior to data exchange. Patient data will be provided in a coded format that protects patient identities but will contain diagnosis (signs/symptoms), interventions including technical observations, diagnostic tests/results, and patient outcomes. Information about the recording device including device serial numbers, device model numbers, date of the event, and country/state of the event will be annotated with the data.
Publications
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.
PubMed 38332136
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Recording of Stereotyped High-Frequency Oscillations With a Closed-Loop Brain Interchange System in Drug-Resistant Epilepsy
- ClinicalTrials.gov ID
- NCT05439655
- Acronym / sponsor ID
- 23-008859
- Conditions
- Epilepsy
- Keywords
- Neuromodulation, HFO, Epilepsy, Machine Learning, Closed-Loop
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Baylor College of Medicine, CorTec GmbH, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 11 Aug 2025 (actual)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 30 Jun 2022 (actual)
- Results
- Posted 15 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 that the SOZ repeatedly generates sets of stereotypical HFOs with similar waveform morphology whereas the events recorded from out of SOZ were irregular. This morphological pattern served as a robust neurobiomarker to isolate SOZ from other brain areas in multiple patients consistently. While these promising preliminary results are in place, the functional utility of stereotyped HFOs in a closed-loop seizure control system remains unknown. As of today, not much is known whether the stereotyped HFOs generated by the SOZ can be detected with an implantable system. If this can be achieved, then HFOs can be strategically translated as a neurobiomarker into closed-loop seizure control applications. The investigators hypothesize that pathologic stereotyped HFOs can be captured with the implantable Brain Interchange (BIC) system of CorTec and spatial topography of these events can be utilized by the implantable system to deliver targeted electrical stimulation to achieve seizure control. Using an acute setup within the epilepsy monitoring unit (EMU), this project will investigate the feasibility of capturing stereotyped HFO events using the new BIC system and compare the detection results to those obtained with the commercially available amplifier (Aim-1). If the first phase (Aim-1) of the study becomes successful, later in the second phase (Aim-2), once again in the EMU, the investigators will deliver targeted electrical stimulation to those brain sites associated with stereotyped HFOs using the BIC.
During the entire study, the BIC system will not be implanted but used externally to assess the neural data through externalized electrodes and then deliver closed-loop stimulation. If the outcomes of the research in an acute setting become successful, the investigators will execute a clinical trial and run our methods with the implanted BIC system in a chronic ambulatory setting.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Epilepsy | Experimental | Device: Brain Interchange Systempatients with drug resistant epilepsy undergoing a surgical evaluation in the epilepsy monitoring unit |
Who may qualify
- Ages
- 3 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- patients with medically refractory epilepsy, who have been deemed appropriate candidates for intracranial EEG monitoring
- Adult men and women (18≤ age ≤64 years)
- children (3≤ age <18 years)
- includes women and minorities
Key exclusion criteria (1 listed)
- Subjects will be excluded if their condition makes them unable to continue with recordings.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain Interchange SystemThe 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. | Device | Epilepsy |
Primary outcome
Packet Loss Rate
Time frame: Over 24 hours
Assessed by the percentage of transmitted data packets (a small unit of information that a device sends across a network) that were not successfully received and recorded by the BIC system in the epilepsy monitoring unit.
Percentage of Clinical Amplifier-Detected High Frequency Oscillations (HFOs) Retained in BIC Recordings
Time frame: Over 24 hours
The outcome was calculated as the proportion of HFO events detected by the clinical amplifier that were also retained in the BIC recording during the 24-hour EMU recording period. The reported value represents a percentage calculated from the total number of retained HFO events divided by the total number of HFO events detected by the clinical amplifier. Because this outcome measure is an event-based proportion calculated from counts of detected HFOs rather than a participant-level variable measured for each participant, a measure type of Number was used rather than a measure of central tendency.
Accuracy of BIC-Derived High Frequency Oscillations for Localization of the Seizure Onset Zone
Time frame: Over 24 hours
Evaluated the ability of BIC-derived HFOs to localize the seizure onset zone during a 24-hour EMU recording.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 38332136Ayyoubi 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.
- Individual participant dataSharing planned: Yes. Intracranial EEG + ECoG recorded from patients with epilepsy will be shared. The electrical signs of neural activity will be collected in the EMU for 24hrs. One stream of data will be digitized at 1kHz with 16bit resolution with the BIC system and the other stream with least a 2 kHz sampling frequency to capture HFOs reaching up to 500Hz. All collected data will be de-identified prior to data exchange. Patient data will be provided in a coded format that protects patient identities but will contain diagnosis (signs/symptoms), interventions including technical observations, diagnostic tests/results, and patient outcomes. Information about the recording device including device serial numbers, device model numbers, date of the event, and country/state of the event will be annotated with the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nuri F Ince, Ph.D. principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Interchange System in people with Epilepsy, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Packet Loss Rate (time frame: Over 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05439655, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.