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NCT Number: NCT04649008

Localizing Epileptic Networks Using MRI and iEEG

Upon successful completion of this study, the investigators expect the study's contribution to be the development of noninvasive imaging biomarkers to predict IEEG functional dynamics and epilepsy surgical outcomes. Findings from the present study may inform current and new therapies to map and alter seizure spread, and pave the way for less invasive, better- targeted, patient-specific interventions with improved surgical outcomes. This research is relevant to public health because over 20 million people worldwide suffer from focal drug-resistant epilepsy and are potential candidates for cure with epilepsy surgical interventions.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Carolyn Wilkinson, BSN

CONTACT

[email protected]

215-746-4850

About this study

Despite recent advances in neuroimaging, approximately 2/3 of intractable epilepsy patients that undergo surgical evaluation continue to require intracranial EEG (IEEG), arguably the most invasive diagnostic test in medicine. Clinicians currently lack methods to quantitatively map noninvasive imaging measures of structure and function to IEEG. Specifically, there is a critical need to validate whole-brain noninvasive neuroimaging network- based biomarkers to guide precise placement of electrodes and translate noninvasive network neuroimaging to change the paradigms of clinical care. The long-term goal of this study is to predict IEEG functional dynamics and surgical outcomes using noninvasive MRI-based measures of structure and function. The investigators' overall objective, which is the next step toward attaining the study's long-term goal, is to develop open-source noninvasive imaging tools that map epileptic networks by integrating MRI and IEEG data. The central hypothesis is that noninvasive measures of structure and function relate to and can predict the intricate functional dynamics captured on IEEG. The central hypothesis will be tested in patients undergoing IEEG targeting the temporal lobe network by pursuing three specific aims: 1) To map the patient specific structural connectome to IEEG seizure onset and propagation, 2) To correlate seizure onset and propagation on IEEG with network measures derived from resting state functional MRI (rsfMRI), and 3) To integrate the structural (Aim 1) and functional (Aim 2) connectome with standard qualitative clinical data to predict IEEG network dynamics and surgical outcomes. Under the first aim patients will undergo diffusion tensor imaging (DTI) prior to stereotactic IEEG, an IEEG method that inherently samples long range networks. The functional IEEG network will be mapped to DTI thus defining how seizures are constrained by the underlying structural connectome as they propagate. Under the second aim patients with temporal lobe epilepsy will undergo rsfMRI on 7T MRI prior to stereotactic IEEG. Functional network measures from rsfMRI and IEEG will be coregistered and rsfMRI will be used to predict functional EEG ictal and interictal networks. In the third aim two models predicting IEEG network dynamics and epilepsy surgical outcomes will be created building off of methods developed in Aims 1 and 2. This research is innovative because it represents a substantive departure from the status quo by directly connecting noninvasive multimodal imaging with measures of functional network dynamics in IEEG. This research is also significant because it is expected that successful completion of these aims will yield personalized strategies for IEEG targeting based on noninvasive neuroimaging.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with medication-refractory epilepsy
  • Planned intracranial EEG (IEEG) placement
  • Hypothesized to have temporal lobe epilepsy

Exclusion criteria

  • Contraindication to 3T MRI (e.g. metal implants or claustrophobia), clinical features that typically preclude the use of IEEG (e.g. pregnancy), prior intracranial surgery or device, and IEEG findings that are non-diagnostic (e.g. seizure onset zone(s) not identified)

Treatment and study plan

3T Magnetic Resonance Imaging

Diagnostic Test

Magnetic resonance imaging acquired at a field strength of 3 Tesla.

Other names: 3T MRI

Intracranial electroencephalography recordings

Diagnostic Test

Epilepsy patients may undergo implantation of intracranial electroencephalography (iEEG) electrodes for localization of epileptogenic foci, which also provide a means to record localized brain activity during memory or other tasks for research purposes.

Other names: Intracranial EEG recordings

7T Magnetic Resonance Imaging

Diagnostic Test

Magnetic resonance imaging acquired at a field strength of 7 Tesla.

Other names: 7T MRI

Primary outcomes

  1. Structure-function coupling

    Time frame: Measure will be assessed upon collection of patient pre-implant MRI study and iEEG recordings, and control MRI

    This study aims to analyze MRI and iEEG to quantify structure-function coupling (SC-FC), specifically between white matter connections and IEEG, across preictal and ictal periods in consecutive patients undergoing IEEG monitoring with SEEG targeting the temporal lobe networks at the University of Pennsylvania and Medical University of South Carolina.

Secondary outcomes

  1. Correlate iEEG seizure onset and propagation with 7T rsfMRI

    Time frame: Measure will be assessed upon collection of patient pre-implant 7T rsfMRI and iEEG recordings, and control 7T MRI

    This study aims to correlate seizure onset and propagation on IEEG with network measures derived from resting-state functional 7T MRI (rsfMRI) in MRI-negative TLE.

  2. Imaging biomarkers for seizure onset

    Time frame: Measure will be assessed upon collection of patient pre-implant 3T and 7T MRI studies and iEEG recordings, and control MRI

    This study aims to correlate non-invasive structural (Outcome 1) and functional (Outcome 2) connectomes and standard clinical data with IEEG network dynamics and surgical outcomes. This represents the first quantitative multi-modal imaging study linking noninvasive imaging to IEEG functional dynamics and epilepsy surgical outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Kathryn A Davis, MD, MSTR

CONTACT

[email protected]

215-349-5166

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Medical University of South Carolina

Registry information

Official study title

Optimized Intracranial EEG Targeting in Focal Epilepsy Based Upon Neuroimaging Connectomics

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Dec 2, 2020
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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