Investigating Dynamic Interactions in Distributed Cognitive Control Networks

Обзор

The purpose of this study is to investigate the brain activity associated with cognitive tasks (thinking, reasoning, remembering) in order to understand how the brain works during certain tasks and to improve treatment for diseases like dementia and attention deficit disorders. Cognitive (thinking) impairment may include poor memory function, poor attention span, or psychiatric disorders (ex: ADD, depression). The investigators are interested in the brain activity related to these issues, and want to investigate changes in brain activity while we record activity from specific areas of the brain. These recordings are in addition to clinical (routine or standard of care) recordings being performed to monitor for seizures and do not impact the clinical care.

Подробное описание

Routine intracranial monitoring (ICM) surgery involves placement of several (10-20) electrodes into the brain through a small opening to a target structure. Participants have been deemed a surgical candidate for this procedure, and detailed discussion of the procedure will occur as part of the surgical consent. The Investigators may place sensors (stickers) to monitor participant's arm/hand movements and brain activity. Sensors may be placed on participant's scalp and/or arms and legs. The Investigators may place a device on participant's wrist or finger to measure position (accelerometer). The Investigators may perform voice recordings, eye movement tracking, and motion capture recordings to obtain measures of how stimulation affects speech and other movements. These are performed without any attachment of devices.

Cognitive tasks: Multiple cognitive tasks may be used and will be decided upon based on the clinical symptoms, exam, or comorbidities. These may include Go/No-go, Simon/Stroop task, Stop-signal task, language tasks, Tower of London, gambling task, maze navigation, choice-reaction time, delay tasks, and attention tasks.

Cortico-cortical evoked potentials and Patterned Stimulation: Stimulus pulses at precise time intervals and or various patterns will be delivered across adjacent electrode contacts at a series of electrode sites while simultaneously recording neural activity at other electrodes. This does not require any activity from participant.

Tasks will be administered via computer monitor positioned in front of the you. This will be connected to a recording computer. Participant will respond via keyboard, mouse, or response button.

Вмешательства

• Диагностический тест Passive testing
  Passive testing includes baseline recordings or behavioral tasks without stimulation. Examples include language tasks, cognitive, and motor tasks. Passive testing typically takes 30-60 minutes and does not require presence of an epileptologist as the tasks are of minimal or no risk.
• Диагностический тест Active testing
  Active testing includes any study activity in which stimulation occurs. The most frequent paradigm consists of delivering small amounts of electrical stimulation through the implanted grid/strip/depth electrodes. This will be either continuous stimulation or patterned stimulation such as intermittent theta-burst . Stimulation will range between 1-8 mAmp. The duration of these pulses will last between 2-5 seconds. Subjects may be asked to rest quietly or to perform behavioral tasks during stimul

Первичные конечные точки

• Go/No-go [Срок оценки: Post-op through study completion, an average of 7 days.]
• Simon/Stroop task [Срок оценки: Post-op through study completion, an average of 7 days.]
• Stop-signal task [Срок оценки: Post-op through study completion, an average of 7 days.]
• Language task [Срок оценки: Post-op through study completion, an average of 7 days.]
• Tower of London [Срок оценки: Post-op Day Post-op through study completion, an average of 7 days.]
• Gambling task [Срок оценки: Post-op through study completion, an average of 7 days.]
• Maze navigation [Срок оценки: Post-op through study completion, an average of 7 days.]
• Choice-reaction time [Срок оценки: Post-op through study completion, an average of 7 days.]
• Delay task [Срок оценки: Post-op through study completion, an average of 7 days.]
• Attention task [Срок оценки: Post-op through study completion, an average of 7 days.]

Критерии участия

Критерии включения

• Eligible for surgery based on multi-disciplinary consensus review
• Have a diagnosis of medically-refractory epilepsy
• A minimum of 18 years of age
• Willingness to participate in the paradigms described in the protocol

Критерии исключения

• Inability to provide full and informed consent
• Age younger than 18
• Are not physically able to participate in study-related activities
• Major medical or surgical complication

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

США · 1 центр

• University of Alabama at Birmingham — Birmingham

Идентификаторы

NCT: NCT05927974 · IRB-300010350 · UAB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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