Neural Basis of Cognition

Study Overview
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Brief Summary
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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.

Official Title
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Studying Human Cognition and Neurological Disorders Using ÂµECoG Electrodes

Conditions
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Epilepsy

Intervention / Treatment
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* Device: High density micro-electrocorticography for neural speech prothesis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | Measure Description | Time Frame |
| --- | --- | --- |
| Number of serious adverse events as measured by medical record review |  | Implantation to Three-months follow-up |