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MRI + iEEG for Epilepsy

Phase < 1
Recruiting
Led By Kathryn A Davis, MD, MSTR
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with medication-refractory epilepsy
Be older than 18 years old
Must not have
Prior intracranial surgery or device
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measure will be assessed upon collection of patient pre-implant 3t and 7t mri studies and ieeg recordings, and control mri
Awards & highlights

Summary

This trial will help researchers develop noninvasive imaging biomarkers to predict how well a person will respond to epilepsy surgery, paving the way for less invasive, better-targeted interventions.

Who is the study for?
This trial is for individuals with drug-resistant epilepsy who are scheduled to have intracranial EEG (IEEG) placement and are thought to have temporal lobe epilepsy. It's not suitable for those with non-diagnostic IEEG results, contraindications to MRI like metal implants or claustrophobia, pregnant individuals, or those who've had prior brain surgery.
What is being tested?
The study tests the use of high-resolution MRIs at 7T and standard 3T alongside IEEG recordings to develop imaging biomarkers that could predict the outcomes of epilepsy surgery. The goal is to improve surgical strategies for seizure control in people with focal drug-resistant epilepsy.
What are the potential side effects?
While this study does not involve drugs, there may be risks associated with undergoing MRIs such as discomfort from loud noises or lying still, and potential issues related to IEEG such as infection risk or discomfort at electrode sites.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My epilepsy does not improve with medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had brain surgery or a device implanted in my brain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measure will be assessed upon collection of patient pre-implant 7t rsfmri and ieeg recordings, and control 7t mri
This trial's timeline: 3 weeks for screening, Varies for treatment, and measure will be assessed upon collection of patient pre-implant 7t rsfmri and ieeg recordings, and control 7t mri for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Structure-function coupling
Secondary study objectives
Correlate iEEG seizure onset and propagation with 7T rsfMRI
Imaging biomarkers for seizure onset

Trial Design

1Treatment groups
Experimental Treatment
Group I: Epilepsy patient volunteersExperimental Treatment3 Interventions
Patients recruited for the study with intractable epilepsy who are anticipated to undergo epilepsy surgery

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,053 Previous Clinical Trials
43,012,837 Total Patients Enrolled
2 Trials studying Epilepsy
377 Patients Enrolled for Epilepsy
Medical University of South CarolinaOTHER
960 Previous Clinical Trials
7,399,270 Total Patients Enrolled
4 Trials studying Epilepsy
526 Patients Enrolled for Epilepsy
Kathryn A Davis, MD, MSTRPrincipal InvestigatorUniversity of Pennsylvania

Media Library

Intracranial electroencephalography recordings Clinical Trial Eligibility Overview. Trial Name: NCT04649008 — Phase < 1
Epilepsy Research Study Groups: Epilepsy patient volunteers
Epilepsy Clinical Trial 2023: Intracranial electroencephalography recordings Highlights & Side Effects. Trial Name: NCT04649008 — Phase < 1
Intracranial electroencephalography recordings 2023 Treatment Timeline for Medical Study. Trial Name: NCT04649008 — Phase < 1
~84 spots leftby Feb 2026
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