Recruiting

Observational Study

Sponsor:

University of Alabama at Birmingham

Code:

NCT05927974

Conditions

Cognitive Impairment

Dementia

ADD

Depression

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Passive testing

Active testing

Study Details

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.

Conditions

Cognitive Impairment

Dementia

ADD

Depression

Study ID

NCT05927974

Start date

Mar 27, 2023

Status verified date

Apr, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Mar 27, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

ICM Patients

Epillipsey Patients undergoing routine intracranial EEG monitoring for epilepsy.

Interventions

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.

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.

Primary outcome measure

  • Go/No-go [ Time Frame: Post-op through study completion, an average of 7 days. ]
  • Simon/Stroop task [ Time Frame: Post-op through study completion, an average of 7 days. ]
  • Stop-signal task [ Time Frame: Post-op through study completion, an average of 7 days. ]
  • Language task [ Time Frame: Post-op through study completion, an average of 7 days. ]
  • Tower of London [ Time Frame: Post-op Day Post-op through study completion, an average of 7 days. ]
  • Gambling task [ Time Frame: Post-op through study completion, an average of 7 days. ]
  • Maze navigation [ Time Frame: Post-op through study completion, an average of 7 days. ]
  • Choice-reaction time [ Time Frame: Post-op through study completion, an average of 7 days. ]
  • Delay task [ Time Frame: Post-op through study completion, an average of 7 days. ]
  • Attention task [ Time Frame: Post-op through study completion, an average of 7 days. ]
  • Cortico-cortical evoked potentials [ Time Frame: Post-op through study completion, an average of 7 days. ]
  • Patterned Stimulation [ Time Frame: Post-op through study completion, an average of 7 days. ]

Central Contacts and Locations

Central contacts

Jessica N Bentley, MD

2059347170jbentley@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Jessica N Bentley, MD

2059347170jbentley@uabmc.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Keywords

  • Cognitive tasks
  • Epilepsy
  • Intracranial EEG

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-04-29.