Advanced MRI Techniques for Pediatric Epilepsy

(DTI/SEP Trial)

Overseen By Bangning Yu, MD, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: No intractable epilepsy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how a special type of MRI, called diffusion tensor imaging, can assist doctors in planning surgeries for children with difficult-to-treat epilepsy. The focus is on observing how this MRI technique functions in children who might require surgery to manage their seizures. The study seeks children diagnosed with intractable epilepsy, meaning their seizures are difficult to control with standard treatments. Participants will have only their MRI results observed, with no new medications or procedures involved. As an unphased trial, this study offers a unique opportunity for participants to contribute to the advancement of surgical planning techniques for epilepsy.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these advanced MRI techniques are safe for children with epilepsy?

Previous studies have shown that MRI (magnetic resonance imaging) has been used safely in many patients. No serious safety concerns are known with MRI, as it is a non-invasive imaging method that does not involve surgery or entering the body. Most people do not experience side effects from MRI scans. However, some might feel uncomfortable if claustrophobic, as the MRI machine resembles a large tube.

MRI does not use radiation, making it safer than some other imaging techniques. Occasionally, a special dye enhances image clarity, but this is not always necessary. If used, there is a small chance of an allergic reaction, though this is rare.

Overall, MRIs are considered very safe for both children and adults.

Why are researchers excited about this trial?

Researchers are excited about using advanced MRI techniques for pediatric epilepsy because these techniques offer a non-invasive way to observe brain changes, potentially leading to better diagnosis and treatment planning. Unlike traditional methods that might involve invasive procedures or medication trials, advanced MRI can provide detailed insights without discomfort or risk to the child. This approach could revolutionize how doctors understand and manage epilepsy by identifying precise brain activity patterns associated with seizures, paving the way for more personalized and effective treatments.

What evidence suggests that these advanced MRI techniques are effective for pediatric epilepsy?

Research has shown that advanced MRI techniques, such as diffusion tensor imaging, can help doctors better understand epilepsy in children. This imaging reveals details about the brain's pathways, which might be involved in seizures. In this trial, participants will join an observational cohort to study changes in MRI scans. Although this study focuses on observing these changes, past research suggests that such imaging insights can aid in planning surgeries for epilepsy. By pinpointing the exact areas of the brain affected, doctors can customize surgical approaches more effectively, potentially leading to better outcomes for children undergoing epilepsy surgery.

Who Is on the Research Team?

Manish N Shah, M.D.

Principal Investigator

UTHealth Medical School

Are You a Good Fit for This Trial?

This clinical trial is specifically for children who have been diagnosed with intractable epilepsy, which means their seizures are not controlled by medication. The study is open to those referred for surgery due to the severity of their condition.

Inclusion Criteria

My child has epilepsy that doesn't respond to treatment.

Exclusion Criteria

I do not have uncontrollable epilepsy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Imaging

Participants undergo standard preoperative MRI imaging, including a 15-minute set of functional connectivity and diffusion tensor sequences

1 week

1 visit (in-person)

Postoperative Imaging

Participants undergo standard postoperative MRI imaging to assess changes

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Observation

Trial Overview The trial is observing how useful diffusion tensor magnetic resonance imaging (DT-MRI) can be in preparing for surgery in these children. DT-MRI is a type of brain scan that helps doctors see how water moves along neural pathways.

How Is the Trial Designed?

Group I: Observational cohort Experimental Treatment 1 Intervention

Observing MRI changes in subjects.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

MRI is the preferred imaging technique for diagnosing and managing epilepsy due to its high sensitivity and ability to provide detailed anatomical information, making it crucial for understanding seizure disorders.

Emerging functional imaging techniques like SPECT, PET, and functional MRI are enhancing the assessment of seizures by allowing noninvasive evaluation of brain activity, metabolism, and neuroreceptor function, which could lead to better treatment strategies for children with epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroimaging in pediatric epilepsy. Kuzniecky, RI.[2022]

Non-invasive cerebral imaging techniques, particularly advanced MRI, have significantly enhanced the ability to detect subtle brain lesions in children with epilepsy, improving presurgical evaluations and understanding of mental health impacts.

Techniques like ictal SPECT and functional MRI are crucial for accurately localizing epileptogenic zones and brain functions, aiding in surgical planning and assessing neuropsychological effects associated with epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cerebral imaging in childhood epilepsy: what's new?]. Chiron, C., Hertz-Pannier, L.[2006]

A new epilepsy-specific MRI protocol was developed based on a study of 2,740 patients, which includes essential sequences like FLAIR and T(2)-weighted images to reliably detect small epileptogenic lesions.

This protocol, featuring specific slice thickness and orientations, aims to improve early identification of patients who may benefit from epilepsy surgery, making it practical for use outside specialized centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proposal for a magnetic resonance imaging protocol for the detection of epileptogenic lesions at early outpatient stages. Wellmer, J., Quesada, CM., Rothe, L., et al.[2022]

In a study of 150 patients with MRI-negative pharmacoresistant focal epilepsy, a voxel-based MRI postprocessing technique (MAP) identified subtle abnormalities in 43% of cases, significantly improving the chances of successful surgical outcomes.

Patients with regions identified by MAP that were completely resected had the best seizure outcomes, highlighting the importance of using MAP to guide surgical decisions in epilepsy treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Voxel-based morphometric magnetic resonance imaging (MRI) postprocessing in MRI-negative epilepsies. Wang, ZI., Jones, SE., Jaisani, Z., et al.[2019]

The 3 Tesla MRI protocol used in this study demonstrated high diagnostic accuracy for identifying lesions in patients with drug-resistant focal epilepsy, with concordance between MRI and histopathology in 101 out of 116 cases.

Despite its effectiveness, the study found that some small focal cortical dysplasia (FCD) lesions could be missed on histopathology due to sampling errors, highlighting the importance of thorough tissue harvesting during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic Accuracy of Epilepsy-dedicated MRI with Post-processing. Urbach, H., Scheiwe, C., Shah, MJ., et al.[2023]

Neuroimaging is essential in evaluating pediatric epilepsy, helping in diagnosis, follow-up, and presurgical assessment by identifying cerebral lesions and alterations associated with focal epilepsy.

Recent advancements in imaging techniques, such as diffusion-weighted imaging (DWI) and functional MRI (fMRI), enhance the accuracy of lesion detection and help map critical brain areas, which is crucial for planning safe epilepsy surgeries and minimizing risks of new complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Narrative review of epilepsy: getting the most out of your neuroimaging. De Vito, A., Mankad, K., Pujar, S., et al.[2021]

In a study of 43 patients with focal refractory epilepsy, a dedicated epilepsy MRI protocol led to the identification of brain lesions in 33% of patients who were previously considered 'non-lesional', highlighting the importance of specialized imaging techniques.

The most commonly missed lesion was hippocampal sclerosis, and 79% of patients with newly identified lesions had EEG features suggesting they could benefit from surgical intervention, emphasizing the need for thorough imaging assessments in epilepsy cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroradiological findings in patients with "non-lesional" focal epilepsy revealed by research protocol. Kreilkamp, BAK., Das, K., Wieshmann, UC., et al.[2019]

MRI is crucial for diagnosing focal epilepsies before surgery, but 16 to 47% of patients may have MRI-negative results, complicating treatment decisions.

Post-operative seizure freedom rates for MRI-negative patients are generally between 40 to 50%, but advancements in imaging techniques and multimodal approaches may enhance candidate selection and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome after epilepsy surgery in children with MRI-negative non-idiopathic focal epilepsies. Bast, T.[2013]

In a study of 99 patients with refractory epilepsy, a low specific absorption rate (SAR) MRI protocol was successfully used to safely localize subdural grids and depth electrodes without any reported clinical adverse events during or immediately after the imaging.

Out of 101 MRI scans performed, 97 were graded as having acceptable image quality, and follow-up imaging for 70 patients showed no unexpected complications in 69 of them, indicating the safety and efficacy of this MRI approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of MRI in the localization of implanted intracranial electrodes for refractory epilepsy. Yazdani, M., Reagan, J., Kocher, M., et al.[2021]

In a study of 56 MRI-negative patients with intractable focal epilepsy who had failed initial surgery, MRI post-processing identified potential targets for re-evaluation in 15 patients, suggesting that advanced imaging techniques can reveal previously overlooked areas for intervention.

Among those with identified targets, patients who underwent further surgery on the unresected regions showed promising outcomes, with two out of ten becoming seizure-free, highlighting the importance of using MRI post-processing to guide surgical decisions in challenging cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Re-review of MRI with post-processing in nonlesional patients in whom epilepsy surgery has failed. Wang, ZI., Suwanpakdee, P., Jones, SE., et al.[2018]

Subtraction ictal SPECT coregistered to MRI (SISCOM) was found to be a feasible and effective method for localizing the epileptogenic zone (PEZ) in children with drug-resistant epilepsy, successfully localizing the PEZ in 51% of cases and providing additional lateralization in 17.6%.

SISCOM proved particularly valuable for patients with non-informative MRI or poorly localizing video-EEG, contributing to a high seizure-free rate of 87.5% in those who underwent resective surgery, with a strong correlation between SISCOM localization and surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subtraction Ictal SPECT coregistered to MRI (SISCOM) as a guide in localizing childhood epilepsy. Foiadelli, T., Lagae, L., Goffin, K., et al.[2022]

Citations