EpilepsyEarly Phase 1NCT04649008
Localizing Epileptic Networks Using MRI and iEEG
A Early Phase 1 study testing 3T Magnetic Resonance Imaging, Intracranial electroencephalography recordings and 7T Magnetic Resonance Imaging in people with Epilepsy and Epilepsy Intractable, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Epilepsy Intractable, Epilepsy, Temporal Lobe
- What is being tested?
- 3T Magnetic Resonance Imaging, Intracranial electroencephalography recordings and 7T Magnetic Resonance Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 28 Feb 2027
- Phase
- Early Phase 1
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with medication-refractory epilepsy
- Planned intracranial EEG (IEEG) placement
- Hypothesized to have temporal lobe epilepsy
Who cannot join
- 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 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, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Carolyn Wilkinson, BSN, 215-746-4850, wilkinsc@seas.upenn.edu
About this study
Official title: Optimized Intracranial EEG Targeting in Focal Epilepsy Based Upon Neuroimaging Connectomics
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.
Read the detailed description
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.
- Conditions
- Epilepsy, Epilepsy Intractable, Epilepsy, Temporal Lobe
- Being tested
- 3T Magnetic Resonance Imaging, Intracranial electroencephalography recordings, 7T Magnetic Resonance Imaging
- Medical subject headings
- Epilepsy, Drug Resistant Epilepsy, Epilepsy, Temporal Lobe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3T Magnetic Resonance ImagingDiagnostic test
Also called 3T MRI
Magnetic resonance imaging acquired at a field strength of 3 Tesla.
Intracranial electroencephalography recordingsDiagnostic test
Also called Intracranial EEG recordings
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 ImagingDiagnostic test
Also called 7T MRI
Magnetic resonance imaging acquired at a field strength of 7 Tesla.
| Study group | Role | What they receive |
|---|---|---|
| Epilepsy patient volunteers | Experimental | Patients recruited for the study with intractable epilepsy who are anticipated to undergo epilepsy surgery Receives: Diagnostic Test: 3T Magnetic Resonance Imaging; Diagnostic Test: Intracranial electroencephalography recordings; Diagnostic Test: 7T Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Measure will be assessed upon collection of patient pre-implant 7T rsfMRI and iEEG recordings, and control 7T MRI
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.
Measured: Measure will be assessed upon collection of patient pre-implant 3T and 7T MRI studies and iEEG recordings, and control MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start1 Mar 2021
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of South Carolina
- Responsible party
- Sponsor
- Investigators
- Kathryn A Davis, MD, MSTR, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649008
- Sponsor's protocol ID
- 819126
- Status last verified
- Feb 2026
- First submitted
- 23 Nov 2020
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 23449171Wiebe 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.
PubMed 22290572de 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.
PubMed 22000136Widdess-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.
PubMed 16808819Tassi 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.
PubMed 12135964Raybaud 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.
PubMed 16838193Colombo 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.
PubMed 12695213Mathern 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.
PubMed 19761453Wolf 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.
PubMed 11498422Detre 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.
PubMed 7574458Verma 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.
PubMed 23360740Maudsley 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.
PubMed 19926450Dlugos 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.
PubMed 27330452Khambhati 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.
PubMed 27568515
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Intracranial EEG Targeting in Focal Epilepsy Based Upon Neuroimaging Connectomics
- ClinicalTrials.gov ID
- NCT04649008
- Acronym / sponsor ID
- 819126
- Conditions
- Epilepsy, Epilepsy Intractable, Epilepsy, Temporal Lobe
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Medical University of South Carolina
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 2 Dec 2020 (actual)
- 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epilepsy patient volunteers | Experimental | Diagnostic Test: 3T Magnetic Resonance Imaging, Diagnostic Test: Intracranial electroencephalography recordings, Diagnostic Test: 7T Magnetic Resonance ImagingPatients recruited for the study with intractable epilepsy who are anticipated to undergo epilepsy surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with medication-refractory epilepsy
- Planned intracranial EEG (IEEG) placement
- Hypothesized to have temporal lobe epilepsy
Key exclusion criteria (1 listed)
- 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)
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 |
|---|---|---|
| 3T Magnetic Resonance ImagingAlso: 3T MRIMagnetic resonance imaging acquired at a field strength of 3 Tesla. | Diagnostic test | Epilepsy patient volunteers |
| Intracranial electroencephalography recordingsAlso: Intracranial EEG recordingsEpilepsy 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. | Diagnostic test | Epilepsy patient volunteers |
| 7T Magnetic Resonance ImagingAlso: 7T MRIMagnetic resonance imaging acquired at a field strength of 7 Tesla. | Diagnostic test | Epilepsy patient volunteers |
Primary outcome
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.
2 secondary outcomes
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
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
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 13 Feb 2026.
- Background: PubMed 23449171Jette N, Wiebe S. Update on the surgical treatment of epilepsy. Curr Opin Neurol. 2013 Apr;26(2):201-7. doi: 10.1097/WCO.0b013e32835ef345.
- Background: PubMed 22290572Wiebe 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.
- Background: PubMed 22000136de 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.
- Background: PubMed 16808819Widdess-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.
- Background: PubMed 12135964Tassi 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.
- Background: PubMed 16838193Raybaud 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.
- Background: PubMed 12695213Colombo 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.
- Background: PubMed 19761453Mathern 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.
- Background: PubMed 11498422Wolf 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.
- Background: PubMed 7574458Detre 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.
- Background: PubMed 23360740Verma 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.
- Background: PubMed 19926450Maudsley 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.
- Individual participant dataSharing planned: Yes. 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.
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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.
Kathryn A Davis, MD, MSTR principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 3T Magnetic Resonance Imaging, Intracranial electroencephalography recordings and 7T Magnetic Resonance Imaging in people with Epilepsy and Epilepsy Intractable, run by University of Pennsylvania 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 3 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: looking for participants now, as of the sponsor's last update on 13 Feb 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Kathryn A Davis, MD, MSTR (215-349-5166, katedavis@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structure-function coupling (time frame: Measure will be assessed upon collection of patient pre-implant MRI study and iEEG recordings, and control MRI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04649008, which also lists 14 linked publications.
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 13 Feb 2026.