High density micro-electrocorticography for neural speech prothesis
DeviceECoG electrodes are thin, high-density, flexible electrode arrays used for recording electrophysiological signals from the brain.
NCT Number: NCT05132543
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.
Trial opening soon.
Get Notified12 year and older
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ECoG electrodes are thin, high-density, flexible electrode arrays used for recording electrophysiological signals from the brain.
Time frame: 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.
Time frame: Intraoperative data collection period, 20 minutes
Time frame: Intraoperative data collection period, 20 minutes
Time frame: Intraoperative data collection period, 20 minutes
Time frame: Implantation to Three-months follow-up
Contact information is provided by the study sponsor or research team.
Gregory B Cogan, PhD
CONTACT
Jessica Carlson
CONTACT
Duke University
Other
Studying Human Cognition and Neurological Disorders Using µECoG Electrodes
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