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

Tracking Information

• First Submitted Date: June 7, 2023
• First Posted Date: July 3, 2023
• Last Update Posted Date: April 26, 2024
• Actual Study Start Date: March 27, 2023
• Estimated Primary Completion Date: March 27, 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 28, 2023)

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Investigating Dynamic Interactions in Distributed Cognitive Control Networks
• Official Title: Investigating Dynamic Interactions in Distributed Cognitive Control Networks
• 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.

• Study Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• Cognitive Impairment
• Dementia
• ADD
• Depression

Intervention

• 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.

Study Groups/Cohorts

ICM Patients

Epillipsey Patients undergoing routine intracranial EEG monitoring for epilepsy.

Interventions:

• Diagnostic Test: Passive testing
• Diagnostic Test: Active testing

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 28, 2023): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 1, 2028
• Estimated Primary Completion Date: March 27, 2027 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05927974
• Other Study ID Numbers: IRB-300010350; UAB ( Other Identifier: UAB )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: J. Nicole Bentley, University of Alabama at Birmingham
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Alabama at Birmingham
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Alabama at Birmingham
• Verification Date: April 2024