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Neural Basis of Cognition

Primary Purpose

Epilepsy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High density micro-electrocorticography for neural speech prothesis
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Epilepsy

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Previous DBS procedure
  • Subject unable to consent to study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Wireless µECoG Prosthesis for Speech

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.
    Percentage of phoneme decoding accuracy as measured by linear decoding model
    Number of HG power modulation as measured by signal power.
    Number of kriging resolution as measured by signal power.

    Secondary Outcome Measures

    Number of serious adverse events as measured by medical record review

    Full Information

    First Posted
    October 25, 2021
    Last Updated
    May 2, 2023
    Sponsor
    Duke University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05132543
    Brief Title
    Neural Basis of Cognition
    Official Title
    Studying Human Cognition and Neurological Disorders Using µECoG Electrodes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2024 (Anticipated)
    Primary Completion Date
    September 15, 2027 (Anticipated)
    Study Completion Date
    September 15, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Duke University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epilepsy

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    38 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Wireless µECoG Prosthesis for Speech
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    High density micro-electrocorticography for neural speech prothesis
    Intervention Description
    ECoG electrodes are thin, high-density, flexible electrode arrays used for recording electrophysiological signals from the brain.
    Primary Outcome Measure Information:
    Title
    Evoked signal-to-noise analysis human brain.
    Description
    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.
    Time Frame
    Intraoperative data collection period, 20 minutes
    Title
    Percentage of phoneme decoding accuracy as measured by linear decoding model
    Time Frame
    Intraoperative data collection period, 20 minutes
    Title
    Number of HG power modulation as measured by signal power.
    Time Frame
    Intraoperative data collection period, 20 minutes
    Title
    Number of kriging resolution as measured by signal power.
    Time Frame
    Intraoperative data collection period, 20 minutes
    Secondary Outcome Measure Information:
    Title
    Number of serious adverse events as measured by medical record review
    Time Frame
    Implantation to Three-months follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: Previous DBS procedure Subject unable to consent to study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gregory B Cogan, PhD
    Phone
    919-681-7601
    Email
    gregory.cogan@duke.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jessica Carlson
    Phone
    (919)668-2841
    Email
    jessica.carlson@duke.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gregory B Cogan, PhD
    Organizational Affiliation
    Duke University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    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.
    IPD Sharing 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.
    IPD Sharing Access Criteria
    DANDI repository

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    Neural Basis of Cognition

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