EpilepsyNCT05132543
Neural Basis of Cognition
A study testing High density micro-electrocorticography for neural speech prothesis in people with Epilepsy, run by Duke University.
Trial summary
The overall purpose of this study is to better understand human cognition and human epilepsy by working with patients undergoing clinical treatment for pharmacologically resistant epilepsy. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- High density micro-electrocorticography for neural speech prothesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to 15 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Potential subjects will come from adult and pediatric patients (between the ages of 12 and 18) undergoing surgery for the treatment of pharmacologically resistant epilepsy, brain tumor resection, brain mass resection, or deep brain stimulation (DBS) for the first time
- Proficient English speakers
- No Major cognitive impairment
Who cannot join
- Previous DBS procedure
- Subject unable to consent to study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Studying Human Cognition and Neurological Disorders Using µECoG Electrodes
The overall purpose of this study is to better understand human cognition and human epilepsy by working with patients undergoing clinical treatment for pharmacologically resistant epilepsy. The investigators will investigate human cognition by conducting controlled experiments that focus on sensory, motor, and cognitive phenomena such as sensory processing, memory, and language. The investigators will also examine the neural underpinnings of epilepsy during both sleep and wakefulness to better understand both the foundations of epilepsy and how epilepsy affects cognition. The investigators hope to use these data to have a better understanding of cognition, epilepsy, and how the two interact. This will potentially lead to better markers for seizure onsets as well as epilepsy more generally. For this research, the investigators will use μECoG arrays manufactured by commercial partners. These arrays have passed all major ISO 10993 bio-compatibility tests. Based on this characterization and use in the intraoperative setting (limited duration and supervised usage), these devices pose a minimal risk to participants. Data will be analyzed and protected using the Duke SSRI protected research data network.
- Conditions
- Epilepsy
- Being tested
- High density micro-electrocorticography for neural speech prothesis
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High density micro-electrocorticography for neural speech prothesisDevice
ECoG electrodes are thin, high-density, flexible electrode arrays used for recording electrophysiological signals from the brain.
| Study group | Role | What they receive |
|---|---|---|
| Wireless µECoG Prosthesis for Speech | Experimental | Not described Receives: Device: High density micro-electrocorticography for neural speech prothesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evoked signal-to-noise analysis human brain.
This study will compare the neural response sensitivity of intraoperative µECoG recording to those of in-unit recordings with macro-ECoG and SEEG. The strength and reliability of the high gamma (HG) response are critical for speech decoding algorithms. For all recordings, the HG power modulation ratio over baseline during speech perception and production will be measured and compared with non-parametric statistical tests.
Measured: Intraoperative data collection period, 20 minutes
Percentage of phoneme decoding accuracy as measured by linear decoding model
Measured: Intraoperative data collection period, 20 minutes
Number of HG power modulation as measured by signal power.
Measured: Intraoperative data collection period, 20 minutes
Number of kriging resolution as measured by signal power.
Measured: Intraoperative data collection period, 20 minutes
Secondary outcomes (1)
Number of serious adverse events as measured by medical record review
Measured: Implantation to Three-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study startSep 2026 (estimated)
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Gregory B Cogan, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132543
- Sponsor's protocol ID
- Pro00072892
- Other IDs
- 5R01DC019498
- Status last verified
- Oct 2025
- First submitted
- 25 Oct 2021
- Last updated
- 17 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following completion of this project and 8 months after acceptance of the primary manuscript(s), the research data will be made available to the scientific community through public repository for neurophysiological data (e.g. Pennsieve and crcns.org) for both research and educational purposes. Recordings from clinical and research electrodes will be de-identified. The investigators will also include the relevant task data, electrode coordinates in MNI and subject specific space, essential de-identified clinical data using NINDS Common Data Elements (age, sex, duration of epilepsy, epilepsy etiology, preoperative imaging findings), schematics of seizure-onset areas, and any relevant scripts needed to manipulate the data. All data will be reviewed prior to upload to ensure they contain no PHI and will be stripped of voice recordings and be HIPAA compliant.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying Human Cognition and Neurological Disorders Using µECoG Electrodes
- ClinicalTrials.gov ID
- NCT05132543
- Acronym / sponsor ID
- Pro00072892
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Sep 2026 (estimated)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall purpose of this study is to better understand human cognition and human epilepsy by working with patients undergoing clinical treatment for pharmacologically resistant epilepsy. The investigators will investigate human cognition by conducting controlled experiments that focus on sensory, motor, and cognitive phenomena such as sensory processing, memory, and language. The investigators will also examine the neural underpinnings of epilepsy during both sleep and wakefulness to better understand both the foundations of epilepsy and how epilepsy affects cognition. The investigators hope to use these data to have a better understanding of cognition, epilepsy, and how the two interact. This will potentially lead to better markers for seizure onsets as well as epilepsy more generally. For this research, the investigators will use μECoG arrays manufactured by commercial partners. These arrays have passed all major ISO 10993 bio-compatibility tests. Based on this characterization and use in the intraoperative setting (limited duration and supervised usage), these devices pose a minimal risk to participants. Data will be analyzed and protected using the Duke SSRI protected research data network.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wireless µECoG Prosthesis for Speech | Experimental | Device: High density micro-electrocorticography for neural speech prothesis |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Potential subjects will come from adult and pediatric patients (between the ages of 12 and 18) undergoing surgery for the treatment of pharmacologically resistant epilepsy, brain tumor resection, brain mass resection, or deep brain stimulation (DBS) for the first time
- Proficient English speakers
- No Major cognitive impairment
Key exclusion criteria (2 listed)
- Previous DBS procedure
- Subject unable to consent to study
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 |
|---|---|---|
| High density micro-electrocorticography for neural speech prothesisECoG electrodes are thin, high-density, flexible electrode arrays used for recording electrophysiological signals from the brain. | Device | Wireless µECoG Prosthesis for Speech |
Primary outcome
Evoked signal-to-noise analysis human brain.
Time frame: Intraoperative data collection period, 20 minutes
This study will compare the neural response sensitivity of intraoperative µECoG recording to those of in-unit recordings with macro-ECoG and SEEG. The strength and reliability of the high gamma (HG) response are critical for speech decoding algorithms. For all recordings, the HG power modulation ratio over baseline during speech perception and production will be measured and compared with non-parametric statistical tests.
Percentage of phoneme decoding accuracy as measured by linear decoding model
Time frame: Intraoperative data collection period, 20 minutes
Number of HG power modulation as measured by signal power.
Time frame: Intraoperative data collection period, 20 minutes
Number of kriging resolution as measured by signal power.
Time frame: Intraoperative data collection period, 20 minutes
1 secondary outcome
Number of serious adverse events as measured by medical record review
Time frame: Implantation to Three-months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: Yes. Following completion of this project and 8 months after acceptance of the primary manuscript(s), the research data will be made available to the scientific community through public repository for neurophysiological data (e.g. Pennsieve and crcns.org) for both research and educational purposes. Recordings from clinical and research electrodes will be de-identified. The investigators will also include the relevant task data, electrode coordinates in MNI and subject specific space, essential de-identified clinical data using NINDS Common Data Elements (age, sex, duration of epilepsy, epilepsy etiology, preoperative imaging findings), schematics of seizure-onset areas, and any relevant scripts needed to manipulate the data. All data will be reviewed prior to upload to ensure they contain no PHI and will be stripped of voice recordings and be HIPAA compliant.
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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.
Gregory B Cogan, PhD principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A study testing High density micro-electrocorticography for neural speech prothesis in people with Epilepsy, run by Duke University.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gregory B Cogan, PhD (919-681-7601, gregory.cogan@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evoked signal-to-noise analysis human brain. (time frame: Intraoperative data collection period, 20 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2026.