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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My epilepsy does not improve with medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measure will be assessed upon collection of patient pre-implant 7t rsfmri and ieeg recordings, and control 7t mri
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Structure-function coupling
Secondary outcome measures
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
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,881,919 Total Patients Enrolled
2 Trials studying Epilepsy
377 Patients Enrolled for Epilepsy
Medical University of South CarolinaOTHER
933 Previous Clinical Trials
7,394,345 Total Patients Enrolled
4 Trials studying Epilepsy
526 Patients Enrolled for Epilepsy
Kathryn A Davis, MD, MSTRPrincipal InvestigatorUniversity of Pennsylvania
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are planning to have electrodes placed in your brain for EEG testing.Your EEG results do not show clear information about where seizures start in your brain.I have had brain surgery or a device implanted in my brain.I am believed to have epilepsy originating in the temporal lobe.You cannot have a 3T MRI scan because you have metal implants or feel very anxious in small spaces.My epilepsy does not improve with medication.
Research Study Groups:
This trial has the following groups:- Group 1: Epilepsy patient volunteers
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment for the experiment currently available?
"Affirmative. The information hosted on clinicaltrials.gov verifies that this trial is still engaging in participant enrolment, as it was first posted on September 1st 2020 and has been recently updated on August 29th 2022. This research effort requires the recruitment of 290 individuals across a single medical centre."
Answered by AI
How many human participants are taking part in the research?
"Affirmative. As per the clinicaltrials.gov platform, this clinical trial which was initially registered on September 1st 2020 is currently looking for patients to take part in it. 290 people are needed from a single site and the data were last updated on August 29th 2022."
Answered by AI
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