Investigating Dynamic Interactions in Distributed Cognitive Control Networks

• ClinicalTrials.gov Identifier: NCT05927974
• Recruitment Status: Recruiting
• First Posted: July 3, 2023
• Last Update Posted: April 26, 2024
• Sponsor: University of Alabama at Birmingham
• Information provided by (Responsible Party): J. Nicole Bentley, University of Alabama at Birmingham

Study Description

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.

Condition or disease	Intervention/treatment
Cognitive Impairment; Dementia; ADD; Depression	Diagnostic Test: Passive testing; Diagnostic Test: Active testing

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 30 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Investigating Dynamic Interactions in Distributed Cognitive Control Networks
• Actual Study Start Date: March 27, 2023
• Estimated Primary Completion Date: March 27, 2027
• Estimated Study Completion Date: January 1, 2028

Groups and Cohorts

Group/Cohort

Intervention/treatment

ICM Patients; Epillipsey Patients undergoing routine intracranial EEG monitoring for epilepsy.

Diagnostic Test: 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.; Diagnostic Test: 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 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.

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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

Contacts and Locations

Contacts

Contact: Jessica N Bentley, MD; 2059347170; jbentley@uabmc.edu

Locations

United States, Alabama

University of Alabama at Birmingham; Recruiting

Birmingham, Alabama, United States, 35233

Contact: Jessica N Bentley, MD 205-934-7170 jbentley@uabmc.edu

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

• Principal Investigator: Jessica N Bentley, MD; The University of Alabama at Birmingham

More Information

• Responsible Party: J. Nicole Bentley, Assistant Professor, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT05927974
• Other Study ID Numbers: IRB-300010350; UAB ( Other Identifier: UAB )
• First Posted: July 3, 2023
• Last Update Posted: April 26, 2024
• Last Verified: April 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by J. Nicole Bentley, University of Alabama at Birmingham:

Cognitive tasks; Epilepsy; Intracranial EEG

Additional relevant MeSH terms:

Dementia; Cognitive Dysfunction; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders