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Neural Basis of Cognition

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Duke University

Status

Not yet enrolling

Conditions

Epilepsy

Treatments

Device: High density micro-electrocorticography for neural speech prothesis

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05132543
Pro00072892
5R01DC019498 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

38 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

38 participants in 1 patient group

Wireless µECoG Prosthesis for Speech
Experimental group
Treatment:
Device: High density micro-electrocorticography for neural speech prothesis

Trial contacts and locations

0

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Central trial contact

Jessica Carlson; Gregory B Cogan, PhD

Data sourced from clinicaltrials.gov

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