Recruiting
Early Phase 1

Epileptic Networks

Sponsor:

University of Pennsylvania

Code:

NCT04649008

Conditions

Epilepsy

Epilepsy Intractable

Epilepsy, Temporal Lobe

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

3T Magnetic Resonance Imaging

Intracranial electroencephalography recordings

7T Magnetic Resonance Imaging

Study Details

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.

Conditions

Epilepsy

Epilepsy Intractable

Epilepsy, Temporal Lobe

Study ID

NCT04649008

Start date

Mar 1, 2021

Status verified date

Feb, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

290 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Epilepsy patient volunteers

Patients recruited for the study with intractable epilepsy who are anticipated to undergo epilepsy surgery

Interventions

3T Magnetic Resonance Imaging

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

Intracranial electroencephalography 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 Imaging

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

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 ]

Central Contacts and Locations

Central contacts

Kathryn A Davis, MD, MSTR

215-349-5166katedavis@pennmedicine.upenn.edu

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Carolyn Wilkinson, BSN

215-746-4850wilkinsc@seas.upenn.edu

More Information

Sponsor

University of Pennsylvania

Last update posted

Feb 13, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-23. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-02-13.