Neural Correlates of Cognition and Mood

NCT04573569 | Completed

• 1 other identifier: NEUROSURG-2019-28063
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Epilepsy, Complex Partial

Outcome Measures

Primary Outcomes (1)

• Percentage of completed cognitive tasks

  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. We are interested in the practical aspects of data acquisition. No comparison is made as no baseline data exists ECoG, SEEG recordings, and eye-tracking data are timestamped, this allows the validated surveys and tasks to be linked precisely. These results will establish the response rate to the intervention allowing calculation of the number of events to use in establishing relationships with the underlying physiology.

  Up to 1 month (Assessments start after Post-operative day 2)

Secondary Outcomes (1)

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

  Up to 1 month (Assessments start after Post-operative day 2)

Interventions

Behavioral testing BEHAVIORAL

Patients recruited for this study have already undergone surgical implantation of invasive electrodes for purpose of localizing and characterizing electrographic seizures as part of the second phase of surgical epilepsy evaluation. Patients who consent and complete enrollment will then 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. These tasks are performed at the will of each patient during their stay in the intensive care unit while surgical electrodes remain.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing Phase II surgical epilepsy localization

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Epilepsy, Complex Partial

Condition Hierarchy (Ancestors)

Epilepsies, Partial; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2018
• First Posted: October 5, 2020
• Study Start: March 28, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: September 10, 2022

Record last verified: 2022-09

Locations

US (1)