Neural Basis of Cognition

Not Applicable

Not yet recruiting

• Conditions: Epilepsy
• Interventions: Device: High density micro-electrocorticography for neural speech prothesis

• Registration Number: NCT05132543
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-25
• Study First Submitted QC: 2021-11-12
• Study First Posted: 2021-11-24
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-22
• Study Start: 2025-04
• Primary Completion: 2027-09-15
• Study Completion: 2027-09-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Wireless µECoG Prosthesis for Speech	High density micro-electrocorticography for neural speech prothesis	-

Primary Outcome Measures

Name	Time	Method
Percentage of phoneme decoding accuracy as measured by linear decoding model	Intraoperative data collection period, 20 minutes
Number of kriging resolution as measured by signal power.	Intraoperative data collection period, 20 minutes
Evoked signal-to-noise analysis human brain.	Intraoperative data collection period, 20 minutes	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.
Number of HG power modulation as measured by signal power.	Intraoperative data collection period, 20 minutes

Secondary Outcome Measures

Name	Time	Method
Number of serious adverse events as measured by medical record review	Implantation to Three-months follow-up