Neural Basis of Cognition

Sponsor
Duke University
Study ID
NCT05132543
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • High density micro-electrocorticography for neural speech prothesis — DEVICE
    ECoG electrodes are thin, high-density, flexible electrode arrays used for recording electrophysiological signals from the brain.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Oct 2025
Primary completion
Sep 15, 2027
Completion
Sep 15, 2027

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Wireless µECoG Prosthesis for Speech

Primary Outcome Measure

Evoked signal-to-noise analysis human brain. [ Time Frame: Intraoperative data collection period, 20 minutes ]

Central Contacts

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