Clinical trial NCT04573569: Neural Correlates of Cognition and Mood
Official title: Neural Correlates of Cognition and Mood
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy, Complex Partial
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing Phase II surgical epilepsy localization

Brief summary: The overall objective of this study is to determine the neural correlates of cognition and mood. This study represents the first preliminary study to begin investigating cognitive and emotional states in patients who have undergone implantation of invasive electrodes for the purpose of seizure localization. In the post-implantation paradigm where patients remain under close supervision with intracranial instrumentation for recording, this study aims to create the platform and preliminary data to inform a larger study for calibrated examination of neural correlates of cognition and mood. As such, this study has the following specific aims:

Aim 1: Establish a portable platform for the assessment of cognitive, behavioral, and emotional tasks with time synchronization to ECoG/SEEG recording platform Aim 2: Quantify the variance in clinical assessments of mood and cognitive function in patients undergoing phase II epilepsy monitoring Aim 3: Assess the relationship between validated surveys/tasks and electrophysiology

Detailed description: Study interventions are limited entirely to validated surveys completed on a computer or tablet PC, as outlined above. Patients may elect to have electrodes to be implanted that are not used in standard-of-care at this institution, but are FDA-approved for the same indications. Patients who consent and complete enrollment will be asked to complete cognitive and behavioral tasks on a portable computer or tablet PC while the invasive electrodes remain implanted. Tasks typically require the patient to think or act and then respond by interacting minimally with the portable computer.

The primary outcome for this study includes percentage of completed cognitive or behavioral tasks as a measure of the feasibility of the administration of these tasks. As this is a feasibility study, we are interested in the practical aspects of data acquisition.

Secondary outcomes include the cognitive and behavioral tasks themselves and their relationship with electrophysiology.

Eligibility criteria: Inclusion Criteria:

* Patient is able to consent for themselves and the patient has or is scheduled for surgically implanted electrodes for the purposes of phase II epilepsy surgical evaluation.

Exclusion Criteria:

* None

Primary outcomes:
measure: Percentage of completed cognitive tasks
timeFrame: Up to 1 month (Assessments start after Post-operative day 2)
Secondary outcomes:
measure: Secondary outcomes include the cognitive and behavioral tasks themselves and their relationship with electrophysiology of the brain.
timeFrame: Up to 1 month (Assessments start after Post-operative day 2)
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References: