Clinical trial NCT05927974: Investigating Dynamic Interactions in Distributed Cognitive Control Networks
Official title: Investigating Dynamic Interactions in Distributed Cognitive Control Networks
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cognitive Impairment
Dementia
ADD
Depression
Keywords: Cognitive tasks
Epilepsy
Intracranial EEG
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with epilepsy undergo a routine surgery to implant electrodes into the brain for intracranial monitoring (ICM) to localize areas of the brain producing seizures.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Go/No-go
timeFrame: Post-op through study completion, an average of 7 days.
measure: Simon/Stroop task
timeFrame: Post-op through study completion, an average of 7 days.
measure: Stop-signal task
timeFrame: Post-op through study completion, an average of 7 days.
measure: Language task
timeFrame: Post-op through study completion, an average of 7 days.
measure: Tower of London
timeFrame: Post-op Day Post-op through study completion, an average of 7 days.
measure: Gambling task
timeFrame: Post-op through study completion, an average of 7 days.
measure: Maze navigation
timeFrame: Post-op through study completion, an average of 7 days.
measure: Choice-reaction time
timeFrame: Post-op through study completion, an average of 7 days.
measure: Delay task
timeFrame: Post-op through study completion, an average of 7 days.
measure: Attention task
timeFrame: Post-op through study completion, an average of 7 days.
measure: Cortico-cortical evoked potentials
timeFrame: Post-op through study completion, an average of 7 days.
measure: Patterned Stimulation
timeFrame: Post-op through study completion, an average of 7 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: The University of Alabama at Birmingham
name: Jessica N Bentley, MD
role: PRINCIPAL_INVESTIGATOR
References: