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
About this trial
This is an interventional basic science trial for Epilepsy
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
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
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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