Localizing Epileptic Networks Using MRI and iEEG
Optimized Intracranial EEG Targeting in Focal Epilepsy Based Upon Neuroimaging Connectomics
1 other identifier
interventional
290
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Mar 2021
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2020
CompletedFirst Posted
Study publicly available on registry
December 2, 2020
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2027
February 13, 2026
February 1, 2026
6 years
November 23, 2020
February 11, 2026
Conditions
Outcome Measures
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.
Measure will be assessed upon collection of patient pre-implant MRI study and iEEG recordings, and control MRI
Secondary Outcomes (2)
Correlate iEEG seizure onset and propagation with 7T rsfMRI
Measure will be assessed upon collection of patient pre-implant 7T rsfMRI and iEEG recordings, and control 7T MRI
Imaging biomarkers for seizure onset
Measure will be assessed upon collection of patient pre-implant 3T and 7T MRI studies and iEEG recordings, and control MRI
Study Arms (1)
Epilepsy patient volunteers
EXPERIMENTALPatients recruited for the study with intractable epilepsy who are anticipated to undergo epilepsy surgery
Interventions
Magnetic resonance imaging acquired at a field strength of 3 Tesla.
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.
Magnetic resonance imaging acquired at a field strength of 7 Tesla.
Eligibility Criteria
You may qualify if:
- Patients with medication-refractory epilepsy
- Planned intracranial EEG (IEEG) placement
- Hypothesized to have temporal lobe epilepsy
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pennsylvanialead
- Medical University of South Carolinacollaborator
Study Sites (1)
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Related Publications (14)
Jette N, Wiebe S. Update on the surgical treatment of epilepsy. Curr Opin Neurol. 2013 Apr;26(2):201-7. doi: 10.1097/WCO.0b013e32835ef345.
PMID: 23449171BACKGROUNDWiebe S. Epilepsy. Outcome patterns in epilepsy surgery--the long-term view. Nat Rev Neurol. 2012 Jan 31;8(3):123-4. doi: 10.1038/nrneurol.2012.9.
PMID: 22290572BACKGROUNDde Tisi J, Bell GS, Peacock JL, McEvoy AW, Harkness WF, Sander JW, Duncan JS. The long-term outcome of adult epilepsy surgery, patterns of seizure remission, and relapse: a cohort study. Lancet. 2011 Oct 15;378(9800):1388-95. doi: 10.1016/S0140-6736(11)60890-8.
PMID: 22000136BACKGROUNDWiddess-Walsh P, Diehl B, Najm I. Neuroimaging of focal cortical dysplasia. J Neuroimaging. 2006 Jul;16(3):185-96. doi: 10.1111/j.1552-6569.2006.00025.x.
PMID: 16808819BACKGROUNDTassi L, Colombo N, Garbelli R, Francione S, Lo Russo G, Mai R, Cardinale F, Cossu M, Ferrario A, Galli C, Bramerio M, Citterio A, Spreafico R. Focal cortical dysplasia: neuropathological subtypes, EEG, neuroimaging and surgical outcome. Brain. 2002 Aug;125(Pt 8):1719-32. doi: 10.1093/brain/awf175.
PMID: 12135964BACKGROUNDRaybaud C, Shroff M, Rutka JT, Chuang SH. Imaging surgical epilepsy in children. Childs Nerv Syst. 2006 Aug;22(8):786-809. doi: 10.1007/s00381-006-0132-5. Epub 2006 Jul 13.
PMID: 16838193BACKGROUNDColombo N, Tassi L, Galli C, Citterio A, Lo Russo G, Scialfa G, Spreafico R. Focal cortical dysplasias: MR imaging, histopathologic, and clinical correlations in surgically treated patients with epilepsy. AJNR Am J Neuroradiol. 2003 Apr;24(4):724-33.
PMID: 12695213BACKGROUNDMathern GW. Challenges in the surgical treatment of epilepsy patients with cortical dysplasia. Epilepsia. 2009 Oct;50 Suppl 9:45-50. doi: 10.1111/j.1528-1167.2009.02294.x.
PMID: 19761453BACKGROUNDWolf RL, Alsop DC, Levy-Reis I, Meyer PT, Maldjian JA, Gonzalez-Atavales J, French JA, Alavi A, Detre JA. Detection of mesial temporal lobe hypoperfusion in patients with temporal lobe epilepsy by use of arterial spin labeled perfusion MR imaging. AJNR Am J Neuroradiol. 2001 Aug;22(7):1334-41.
PMID: 11498422BACKGROUNDDetre JA, Sirven JI, Alsop DC, O'Connor MJ, French JA. Localization of subclinical ictal activity by functional magnetic resonance imaging: correlation with invasive monitoring. Ann Neurol. 1995 Oct;38(4):618-24. doi: 10.1002/ana.410380410.
PMID: 7574458BACKGROUNDVerma G, Woo JH, Chawla S, Wang S, Sheriff S, Elman LB, McCluskey LF, Grossman M, Melhem ER, Maudsley AA, Poptani H. Whole-brain analysis of amyotrophic lateral sclerosis by using echo-planar spectroscopic imaging. Radiology. 2013 Jun;267(3):851-7. doi: 10.1148/radiol.13121148. Epub 2013 Jan 29.
PMID: 23360740BACKGROUNDMaudsley AA, Domenig C, Ramsay RE, Bowen BC. Application of volumetric MR spectroscopic imaging for localization of neocortical epilepsy. Epilepsy Res. 2010 Feb;88(2-3):127-38. doi: 10.1016/j.eplepsyres.2009.10.009. Epub 2009 Nov 17.
PMID: 19926450BACKGROUNDDlugos D, Worrell G, Davis K, Stacey W, Szaflarski J, Kanner A, Sunderam S, Rogawski M, Jackson-Ayotunde P, Loddenkemper T, Diehl B, Fureman B, Dingledine R; Epilepsy Benchmark Stewards. 2014 Epilepsy Benchmarks Area III: Improve Treatment Options for Controlling Seizures and Epilepsy-Related Conditions Without Side Effects. Epilepsy Curr. 2016 May-Jun;16(3):192-7. doi: 10.5698/1535-7511-16.3.192. No abstract available.
PMID: 27330452BACKGROUNDKhambhati AN, Davis KA, Lucas TH, Litt B, Bassett DS. Virtual Cortical Resection Reveals Push-Pull Network Control Preceding Seizure Evolution. Neuron. 2016 Sep 7;91(5):1170-1182. doi: 10.1016/j.neuron.2016.07.039. Epub 2016 Aug 25.
PMID: 27568515BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathryn A Davis, MD, MSTR
University of Pennsylvania
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2020
First Posted
December 2, 2020
Study Start
March 1, 2021
Primary Completion (Estimated)
February 28, 2027
Study Completion (Estimated)
February 28, 2027
Last Updated
February 13, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- Data will be uploaded to IEEG.org as it is collected in this study will be hosted there while funding remains available for the portal.
- Access Criteria
- The IEEG.org portal is open to users internationally who register or use the database as a guest.
Upon completion of this study and dissemination of primary study results, the analysis data files will be made available to the public, along with the final version of the study protocol, the data dictionary, and brief instructions ("Readme" file). Public use data files and the accompanying documents will be made available through the National Technical Information Service (NTIS). Each data file (including MRI images) will be stripped of any and all personal identifiers and will undergo de-identification. The datasets, analytical results, and analysis software used in the investigators' applications will be hosted on the NIH-funded IEEG.org portal that has been co-developed over the past almost 10 years. IEEG.org already hosts over 150 IEEG datasets and has over 3900 users, and links to software and algorithms on GitHub.