Neural Basis of Cognition
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High density micro-electrocorticography for neural speech prothesis.
- Who it may be relevant to
- Registry conditions: Epilepsy. Basic parameters: from 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Studying Human Cognition and Neurological Disorders Using µECoG Electrodes
Overview
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.
Interventions
- Device High density micro-electrocorticography for neural speech prothesis
ECoG electrodes are thin, high-density, flexible electrode arrays used for recording electrophysiological signals from the brain.
Primary outcome measures
- Evoked signal-to-noise analysis human brain. [Time frame: Intraoperative data collection period, 20 minutes]
- Percentage of phoneme decoding accuracy as measured by linear decoding model [Time frame: Intraoperative data collection period, 20 minutes]
- Number of HG power modulation as measured by signal power. [Time frame: Intraoperative data collection period, 20 minutes]
- Number of kriging resolution as measured by signal power. [Time frame: Intraoperative data collection period, 20 minutes]
Secondary outcome measures (1)
- Number of serious adverse events as measured by medical record review [Time frame: Implantation to Three-months follow-up]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05132543 · Pro00072892 · 5R01DC019498