NCT05927974

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
20mo left

Started Mar 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Mar 2023Jan 2028

Study Start

First participant enrolled

March 27, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

4 years

First QC Date

June 7, 2023

Last Update Submit

April 23, 2026

Conditions

Cognitive ImpairmentDementiaADDDepression

Keywords

Cognitive tasksEpilepsyIntracranial EEG

Outcome Measures

Primary Outcomes (12)

  • Go/No-go

    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.

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

  • Simon/Stroop task

    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.

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

  • Stop-signal task

    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.

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

  • Language task

    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.

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

  • Tower of London

    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.

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

  • Gambling task

    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.

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

  • Maze navigation

    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.

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

  • Choice-reaction time

    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.

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

  • Delay task

    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.

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

  • Attention task

    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.

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

  • Cortico-cortical evoked potentials

    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.

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

  • Patterned Stimulation

    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.

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

Study Arms (1)

ICM Patients

Epillipsey Patients undergoing routine intracranial EEG monitoring for epilepsy.

Diagnostic Test: Passive testingDiagnostic Test: Active testing

Interventions

Passive testingDIAGNOSTIC_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.

ICM Patients
Active testingDIAGNOSTIC_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.

ICM Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

MeSH Terms

Conditions

Cognitive DysfunctionDementiaDepressionEpilepsy

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavioral SymptomsBehavior

Study Officials

  • Jessica N Bentley, MD

    The University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica N Bentley, MD

CONTACT

2059347170jbentley@uabmc.edu

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 7, 2023

First Posted

July 3, 2023

Study Start

March 27, 2023

Primary Completion (Estimated)

March 27, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)