Neural Basis of Cognition

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Epilepsy
• Intervention / Treatment: Device: High density micro-electrocorticography for neural speech prothesis

• Study Type: Interventional
• Enrollment (Anticipated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gregory B Cogan, PhD; Phone Number: 919-681-7601; Email: gregory.cogan@duke.edu
• Study Contact Backup: Name: Jessica Carlson; Phone Number: (919)668-2841; Email: jessica.carlson@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Wireless µECoG Prosthesis for Speech	Device: High density micro-electrocorticography for neural speech prothesis; ECoG electrodes are thin, high-density, flexible electrode arrays used for recording electrophysiological signals from the brain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Number of serious adverse events as measured by medical record review	Implantation to Three-months follow-up

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Gregory B Cogan, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2024
• Primary Completion (Anticipated): September 15, 2027
• Study Completion (Anticipated): September 15, 2027

Study Registration Dates

• First Submitted: October 25, 2021
• First Submitted That Met QC Criteria: November 12, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: Pro00072892

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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
• IPD Sharing Supporting Information Type: ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No