An Examination of Cognitive and Sensorimotor Processes in Patients With Epilepsy

Not Applicable

• Conditions: Epilepsy
• Interventions: Other: fMRI; Other: Neuropsychological Testing; Other: Additional electrode implantation; Other: Electrical brain stimulation

• Registration Number: NCT00859794
• Lead Sponsor: Northwell Health

Brief Summary

The overall goal of this project is to better understand the micro-physiology of human epilepsy and cognition using the intracranial electroencephalogram (iEEG), electrical brain stimulation, functional magnetic resonance imaging (fMRI), and histology.

Detailed Description

The overall goal of this project is to better understand the micro-physiology of human epilepsy and cognition using iEEG, electrical brain stimulation, fMRI, and histology.

Specific AIM 1: Mapping cognitive networks using intracranial electrodes, functional magnetic resonance imaging, and cognitive tasks. To identify brain areas and mechanisms involved in cognitive function we will ask participants to perform tasks while their brain activity is measured with intracranial electrodes or functional magnetic resonance imaging (fMRI).

Specific AIM 2: Using microelectrodes to better understand the mechanisms of seizure genesis/spread and human cognitive function. We will use microelectrodes to measure activity within single neurons, data that will allow us to tease apart incoming and outgoing activity to a brain area.

Specific AIM 3: Using macroscale measures of brain connectivity to map functional and epileptogenic brain areas. We will measure connectivity between macroscale brain regions via variety of techniques: diffusion tensor imaging (DTI), fMRI, cortico-cortical evoked potentials (CCEP), and intracranial electrophysiology. We believe that epileptogenic and functional regions will be mutually segregated by their connectivity patterns.

Specific AIM 4: Using EEG/iEEG source localization to better identify the sources of epileptiform activity. We will construct models of participants' heads via MRI and CT, which will potentially allow us to localize the neural generators of EEG and iEEG recordings.

Specific AIM 5: Investigating the effects of transcranial and direct electrical stimulation on cortical excitability and cognitive function. We will apply direct electrical brain stimulation to epileptogenic and functional brain regions and evaluate the effects of this stimulation on electrode recordings, CCEPs, and cognitive tasks. Electrical stimulation may be applied with consideration of endogenous cognitive biomarkers to probe and elucidate the function of these biomarkers as they relate to cognitive function.

Specific AIM 6: Studying local connectivity of epileptic brain tissue with histology. We will reserve a small portion of resected brain tissue from patients who have undergone surgical resection for histological analysis to better understand altered patterns of neural connectivity in epilepsy.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2009-03-10
• Study First Submitted QC: 2009-03-10
• Study First Posted: 2009-03-11
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-02-01
• Primary Completion: 2029-02
• Study Completion: 2029-02

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Subjects are selected on the basis of intractability of their seizures to medical intervention by antiepileptic drugs and following a noninvasive workup that indicates the patient would be an excellent candidate for resective surgery.

Exclusion Criteria

• Patient is under the age of 5

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cognitive and Behavioral Testing	fMRI	Participants will participate in cognitive tasks where brain recordings and task performance will be monitored and recorded.
Cognitive and Behavioral Testing	Neuropsychological Testing	Participants will participate in cognitive tasks where brain recordings and task performance will be monitored and recorded.
Cognitive and Behavioral Testing	Additional electrode implantation	Participants will participate in cognitive tasks where brain recordings and task performance will be monitored and recorded.
Cognitive and Behavioral Testing	Electrical brain stimulation	Participants will participate in cognitive tasks where brain recordings and task performance will be monitored and recorded.

Primary Outcome Measures

Name	Time	Method
Change in electrophysiological markers (local field potential power and phase) during cognitive tasks	up to 4 weeks	We will compare brain recordings during distinct cognitive functional states, as defined by performance and participation in cognitive tasks (typically task vs resting state). Power and phase measures isolated from local field potentials in implanted electrodes will be assessed. Neuronal firing rates will also be assessed.
Change in memory performance	up to 4 weeks	We will measure the change in memory performance in memory tasks (percent of items correctly recalled).
Change in decision-making performance	up to 4 weeks	We will measure the change in performance (reaction time and accuracy) in decision-making tasks.
Decrease in seizure frequency after epilepsy surgical treatment	up to 4 weeks	We are interested in identifying specific factors that predict the effects of epilepsy surgery on seizure control. We will start by assessing electrographic (seizure foci and spread), imaging (cortical volume, presence of structural pathology), and surgical (extent of surgical resection) factors.
Change in sensory perception	up to 4 weeks	We will measure the change in performance in auditory/visual perception tasks (percent of items correctly perceived).

Trial Locations

Locations (1)

Comprehensive Epilepsy Care Center; 🇺🇸 Great Neck, New York, United States