Neural Basis of Cognition

NCT05132543 | Not Yet Recruiting

• 2 other identifiers: Pro000728925R01DC019498
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (4)

• 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.

  Intraoperative data collection period, 20 minutes

• Percentage of phoneme decoding accuracy as measured by linear decoding model

  Intraoperative data collection period, 20 minutes

• Number of HG power modulation as measured by signal power.

  Intraoperative data collection period, 20 minutes

• Number of kriging resolution as measured by signal power.

  Intraoperative data collection period, 20 minutes

Secondary Outcomes (1)

• Number of serious adverse events as measured by medical record review

  Implantation to Three-months follow-up

Study Arms (1)

Wireless µECoG Prosthesis for Speech

EXPERIMENTAL

Device: High density micro-electrocorticography for neural speech prothesis

Interventions

High density micro-electrocorticography for neural speech prothesis DEVICE

ECoG electrodes are thin, high-density, flexible electrode arrays used for recording electrophysiological signals from the brain.

Wireless µECoG Prosthesis for Speech

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous DBS procedure
• Subject unable to consent to study

Sponsors & Collaborators

• Duke University: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Gregory B Cogan, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory B Cogan, PhD

CONTACT

919-681-7601; gregory.cogan@duke.edu

Jessica Carlson

CONTACT

(919)668-2841; jessica.carlson@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 24, 2021
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: March 13, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, ANALYTIC CODE
• Time Frame: 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.
• Access Criteria: DANDI repository