EpilepsyNCT00859794
An Examination of Cognitive and Sensorimotor Processes in Patients With Epilepsy
A study testing fMRI, Neuropsychological Testing and Additional electrode implantation in people with Epilepsy, run by Northwell Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- fMRI, Neuropsychological Testing and Additional electrode implantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patient is under the age of 5
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Comprehensive Epilepsy Care Center
Great Neck, New York, 11021
About this study
Official title: An Examination of Cognitive and Sensorimotor Processes in Patients With Epilepsy Using Electrophysiology, Cortical Mapping, Electrical Brain Stimulation, and fMRI
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.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- fMRI, Neuropsychological Testing, Additional electrode implantation, Electrical brain stimulation
- Keywords
- Epilepsy, fMRI, Electrophysiology, Cortical Mapping, Neurosurgery
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIOther
Subjects will perform cognitive tasks during MRI scanning sessions to gather data about cognitive functions.
Neuropsychological TestingOther
Subjects will have a neuropsych evaluation as part of their standard of care for surgery. The research team is asking the subject to release their neuropsychological evaluations for analysis.
Additional electrode implantationOther
Subjects will typically have between 100-300 electrodes implanted as part of their surgery. Additional electrodes will be implanted that are able to record from smaller, more specific parts of the brain. This will allow for better understanding of how the brain is wired.
Electrical brain stimulationOther
Intracranial or extracranial electrodes will be used to deliver electrical brain stimulation (amplitude 0.5-8.0mA) or sham stimulation of between 0.4 and 3000 milliseconds during cognitive task periods.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive and Behavioral Testing | Experimental | Participants will participate in cognitive tasks where brain recordings and task performance will be monitored and recorded. Receives: Other: fMRI; Other: Neuropsychological Testing; Other: Additional electrode implantation; Other: Electrical brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in seizure frequency after epilepsy surgical treatment
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.
Measured: up to 4 weeks
Change in electrophysiological markers (local field potential power and phase) during cognitive tasks
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.
Measured: up to 4 weeks
Change in memory performance
We will measure the change in memory performance in memory tasks (percent of items correctly recalled).
Measured: up to 4 weeks
Change in decision-making performance
We will measure the change in performance (reaction time and accuracy) in decision-making tasks.
Measured: up to 4 weeks
Change in sensory perception
We will measure the change in performance in auditory/visual perception tasks (percent of items correctly perceived).
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2009 (estimated)
- Study startNov 2007
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashesh Mehta, M.D., Ph.D., Principal investigator, Zucker School of Medicine at Hofstra/Northwell and Feinstein Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859794
- Sponsor's protocol ID
- 07-125
- Status last verified
- Oct 2026
- First submitted
- 10 Mar 2009
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Examination of Cognitive and Sensorimotor Processes in Patients With Epilepsy Using Electrophysiology, Cortical Mapping, Electrical Brain Stimulation, and fMRI
- ClinicalTrials.gov ID
- NCT00859794
- Acronym / sponsor ID
- 07-125
- Conditions
- Epilepsy
- Keywords
- Epilepsy, fMRI, Electrophysiology, Cortical Mapping, Neurosurgery
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Nov 2007 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 11 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive and Behavioral Testing | Experimental | Other: fMRI, Other: Neuropsychological Testing, Other: Additional electrode implantation, Other: Electrical brain stimulationParticipants will participate in cognitive tasks where brain recordings and task performance will be monitored and recorded. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patient is under the age of 5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRISubjects will perform cognitive tasks during MRI scanning sessions to gather data about cognitive functions. | Other | Cognitive and Behavioral Testing |
| Neuropsychological TestingSubjects will have a neuropsych evaluation as part of their standard of care for surgery. The research team is asking the subject to release their neuropsychological evaluations for analysis. | Other | Cognitive and Behavioral Testing |
| Additional electrode implantationSubjects will typically have between 100-300 electrodes implanted as part of their surgery. Additional electrodes will be implanted that are able to record from smaller, more specific parts of the brain. This will allow for better understanding of how the brain is wired. | Other | Cognitive and Behavioral Testing |
| Electrical brain stimulationIntracranial or extracranial electrodes will be used to deliver electrical brain stimulation (amplitude 0.5-8.0mA) or sham stimulation of between 0.4 and 3000 milliseconds during cognitive task periods. | Other | Cognitive and Behavioral Testing |
Primary outcome
Decrease in seizure frequency after epilepsy surgical treatment
Time frame: 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 electrophysiological markers (local field potential power and phase) during cognitive tasks
Time frame: 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
Time frame: 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
Time frame: up to 4 weeks
We will measure the change in performance (reaction time and accuracy) in decision-making tasks.
Change in sensory perception
Time frame: up to 4 weeks
We will measure the change in performance in auditory/visual perception tasks (percent of items correctly perceived).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashesh Mehta, M.D., Ph.D. principal investigator
Zucker School of Medicine at Hofstra/Northwell and Feinstein Institute for Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI, Neuropsychological Testing and Additional electrode implantation in people with Epilepsy, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in seizure frequency after epilepsy surgical treatment (time frame: up to 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.