Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT05132543

Neural Basis of Cognition

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Evoked signal-to-noise analysis human 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.

  2. Percentage of phoneme decoding accuracy as measured by linear decoding model

    Time frame: Intraoperative data collection period, 20 minutes

  3. Number of HG power modulation as measured by signal power.

    Time frame: Intraoperative data collection period, 20 minutes

  4. Number of kriging resolution as measured by signal power.

    Time frame: Intraoperative data collection period, 20 minutes

Secondary outcomes

  1. Number of serious adverse events as measured by medical record review

    Time frame: Implantation to Three-months follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Gregory B Cogan, PhD

CONTACT

[email protected]

919-681-7601

Jessica Carlson

CONTACT

[email protected]

(919)668-2841

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

Studying Human Cognition and Neurological Disorders Using µECoG Electrodes

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 24, 2021
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.