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Localizing Epileptic Networks Using MRI and iEEG

ConditionsEpilepsyEpilepsy IntractableEpilepsy, Temporal Lobe
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients with medication-refractory epilepsy

Planned intracranial EEG (IEEG) placement

Hypothesized to have temporal lobe epilepsy

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • 3T Magnetic Resonance Imaging

    Diagnostic test

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

  • 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.

  • 7T Magnetic Resonance Imaging

    Diagnostic test

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

Treatment groups

290 Participants
are divided into 1 treatment group
Group A: Epilepsy patient volunteersExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Structure-function coupling

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.

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

Secondary outcomes

1

Correlate iEEG seizure onset and propagation with 7T rsfMRI

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.

Time frame
Measure will be assessed upon collection of patient pre-implant 7T rsfMRI and iEEG recordings, and control 7T MRI
2

Imaging biomarkers for seizure onset

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

Medical University of South Carolina

Collaborator

Source ClinicalTrials.gov
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