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NCT Number: NCT05927974

Investigating Dynamic Interactions in Distributed Cognitive Control Networks

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.

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Key information

Conditions

Cognitive Impairment ADD Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Depression Epilepsy Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location status: Recruiting

Location contact

Jessica N Bentley, MD

CONTACT

[email protected]

2059347170

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Passive testing

Diagnostic Test

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.

Active testing

Diagnostic Test

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 stimulation. Since there is a risk of evoking seizure activity with active testing, presence of an epileptologist is required. Active testing will only occur once the PI/staff has communicated with the epileptologist regarding safety, feasibility, and timing of active testing. Active testing will typically take 60-90 minutes and is only performed once patients are back on their anti-seizure medications.

Primary outcomes

  1. Go/No-go

    Time frame: Post-op through study completion, an average of 7 days.

    Cognitive tasks given will be decided upon based on the clinical symptoms, exam, or comorbidities. Tasks will be administered via computer monitor positioned in front of the subject. This will be connected to a recording computer. Participants will respond via keyboard, mouse, or response button.

  2. Simon/Stroop task

    Time frame: Post-op through study completion, an average of 7 days.

    Cognitive tasks given will be decided upon based on the clinical symptoms, exam, or comorbidities. Tasks will be administered via computer monitor positioned in front of the subject. This will be connected to a recording computer. Participants will respond via keyboard, mouse, or response button.

  3. Stop-signal task

    Time frame: Post-op through study completion, an average of 7 days.

    Cognitive tasks given will be decided upon based on the clinical symptoms, exam, or comorbidities. Tasks will be administered via computer monitor positioned in front of the subject. This will be connected to a recording computer. Participants will respond via keyboard, mouse, or response button.

  4. Language task

    Time frame: Post-op through study completion, an average of 7 days.

    Cognitive tasks given will be decided upon based on the clinical symptoms, exam, or comorbidities. Tasks will be administered via computer monitor positioned in front of the subject. This will be connected to a recording computer. Participants will respond via keyboard, mouse, or response button.

  5. Tower of London

    Time frame: Post-op Day Post-op through study completion, an average of 7 days.

    Cognitive tasks given will be decided upon based on the clinical symptoms, exam, or comorbidities. Tasks will be administered via computer monitor positioned in front of the subject. This will be connected to a recording computer. Participants will respond via keyboard, mouse, or response button.

  6. Gambling task

    Time frame: Post-op through study completion, an average of 7 days.

    Cognitive tasks given will be decided upon based on the clinical symptoms, exam, or comorbidities. Tasks will be administered via computer monitor positioned in front of the subject. This will be connected to a recording computer. Participants will respond via keyboard, mouse, or response button.

  7. Maze navigation

    Time frame: Post-op through study completion, an average of 7 days.

    Cognitive tasks given will be decided upon based on the clinical symptoms, exam, or comorbidities. Tasks will be administered via computer monitor positioned in front of the subject. This will be connected to a recording computer. Participants will respond via keyboard, mouse, or response button.

  8. Choice-reaction time

    Time frame: Post-op through study completion, an average of 7 days.

    Cognitive tasks given will be decided upon based on the clinical symptoms, exam, or comorbidities. Tasks will be administered via computer monitor positioned in front of the subject. This will be connected to a recording computer. Participants will respond via keyboard, mouse, or response button.

  9. Delay task

    Time frame: Post-op through study completion, an average of 7 days.

    Cognitive tasks given will be decided upon based on the clinical symptoms, exam, or comorbidities. Tasks will be administered via computer monitor positioned in front of the subject. This will be connected to a recording computer. Participants will respond via keyboard, mouse, or response button.

  10. Attention task

    Time frame: Post-op through study completion, an average of 7 days.

    Cognitive tasks given will be decided upon based on the clinical symptoms, exam, or comorbidities. Tasks will be administered via computer monitor positioned in front of the subject. This will be connected to a recording computer. Participants will respond via keyboard, mouse, or response button.

  11. Cortico-cortical evoked potentials

    Time frame: Post-op through study completion, an average of 7 days.

    Stimulus pulses at precise time intervals will be delivered across adjacent electrode contacts at a series of electrode sites while simultaneously recording neural activity at other electrodes.

  12. Patterned Stimulation

    Time frame: Post-op through study completion, an average of 7 days.

    Stimulus pulses at various patterns will be delivered across adjacent electrode contacts at a series of electrode sites while simultaneously recording neural activity at other electrodes.

Study contacts

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

Jessica N Bentley, MD

CONTACT

[email protected]

2059347170

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Jul 3, 2023
Registry last updated
Apr 29, 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.

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