Neural Basis of Cognition

Официальное название

Studying Human Cognition and Neurological Disorders Using µECoG Electrodes

Обзор

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Evoked signal-to-noise analysis human brain. [Срок оценки: Intraoperative data collection period, 20 minutes]
• Percentage of phoneme decoding accuracy as measured by linear decoding model [Срок оценки: Intraoperative data collection period, 20 minutes]
• Number of HG power modulation as measured by signal power. [Срок оценки: Intraoperative data collection period, 20 minutes]
• Number of kriging resolution as measured by signal power. [Срок оценки: Intraoperative data collection period, 20 minutes]

Вторичные конечные точки (1)

• Number of serious adverse events as measured by medical record review [Срок оценки: Implantation to Three-months follow-up]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Previous DBS procedure
• Subject unable to consent to study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05132543 · Pro00072892 · 5R01DC019498

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗