Advanced MRI Techniques for Epilepsy

Overseen By Justin J Jeong, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Wayne State University

Disqualifiers: Prematurity, Hemiplegia, Autism, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new MRI technique to aid in planning surgeries for children with drug-resistant focal epilepsy. The goal is to use advanced imaging to better map the brain before surgery, reducing risks and increasing the chances of stopping seizures. Participants include children and teens with epilepsy unresponsive to medication and scheduled for a specific type of surgery. The trial employs brain scans and cognitive assessments to evaluate the effectiveness of this new approach. Importantly, the results will not influence any immediate medical decisions until proven effective. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could improve surgical outcomes for future patients.

Will I have to stop taking my current medications?

The trial does not specify whether participants need to stop taking their current medications. It focuses on advanced MRI techniques and does not mention any medication changes.

What prior data suggests that this MRI technique is safe for pediatric epilepsy surgery?

Research has shown that MRI (magnetic resonance imaging) provides a safe and comfortable way to study epilepsy in children. For instance, studies have found that advanced MRI machines, such as the 7T MRI, are well-tolerated by children with epilepsy. This method effectively identifies brain issues without causing significant discomfort or harm. Importantly, these MRI procedures do not require contrast agents or sedation, further reducing the risk of side effects.

In summary, MRI is a non-invasive imaging method with a strong safety record, making it a reliable tool for research and clinical use, especially in children with epilepsy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using advanced MRI techniques for epilepsy because these methods offer a new way to understand what's happening in the brain of patients with drug-resistant epilepsy. Unlike traditional treatments, which often focus on managing symptoms with medications like anti-seizure drugs, this approach provides detailed images and insights into brain structure and function before and after surgery. This could help tailor surgical interventions more precisely, potentially leading to better outcomes for patients who haven't found relief through drugs alone. By capturing changes over time, these MRI techniques might reveal how epilepsy affects the brain, paving the way for more personalized and effective treatment strategies.

What evidence suggests that this advanced MRI technique is effective for epilepsy?

Research has shown that advanced MRI techniques play a crucial role in treating epilepsy, especially when medications fail. In this trial, participants with drug-resistant epilepsy will undergo two longitudinal brain MRI evaluations. Imaging studies have found that MRI can detect changes in the brains of those with drug-resistant epilepsy. By enhancing MRI sensitivity, doctors can plan surgeries more effectively, leading to improved outcomes. For instance, one study found that patients whose initial MRI showed no issues could still benefit from surgery with enhanced imaging techniques. Overall, advanced MRI methods offer hope for better surgery planning and outcomes in epilepsy treatment. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for children and adolescents aged 3-19 with drug-resistant focal epilepsy who are planning to undergo a specific two-stage surgery, as well as healthy controls aged 5-19. Participants must not have claustrophobia, pervasive developmental or psychiatric conditions predating seizures, significant brain malformations, history of prematurity or hypoxic-ischemic events, hemiplegia, dysmorphic syndromes, or excessive head motion during MRI.

Inclusion Criteria

I am between 3-19 years old with epilepsy not improved by medication, planning a specific surgery.

I am aged 5-19, healthy, with no cognitive or motor issues, and a normal brain MRI.

Exclusion Criteria

Hemiplegia on preoperative neurological examination by pediatric neurologists

History of claustrophobia

MRI abnormalities showing massive brain malformation and other extensive lesions affecting spatial normalization accuracy and parcellation accuracy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Evaluation

Participants undergo advanced brain MRI and neurocognitive evaluation to assess preoperative conditions

1 month

1 visit (in-person)

Surgery and Immediate Postoperative Assessment

Participants undergo epilepsy surgery and immediate postoperative assessment using DCNN tract classification

During procedure

Follow-up

Participants are monitored for safety and effectiveness, including neurocognitive outcomes, after surgery

1.5 years

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Brain Magnetic Resonance Imaging

Trial Overview The study is testing a new diffusion-weighted MRI technique that aims to improve surgical outcomes in pediatric epilepsy by better identifying critical brain pathways. It uses advanced imaging and neurocognitive tests without the need for contrast agents or sedation. The goal is to reduce postoperative deficits while increasing the chance of seizure freedom.

How Is the Trial Designed?

Group I: Patients with drug-resistant epilepsy Experimental Treatment 2 Interventions

All patients who undergo two-stage epilepsy surgery will receive two longitudinal evaluations of brain MRI and neuropsychology test: a month before surgery and 1.5 years after surgery.

Brain Magnetic Resonance Imaging is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as MRI for:

• Diagnostic imaging for various conditions including epilepsy

Approved in United States as MRI for:

• Diagnostic imaging for various conditions including epilepsy

Approved in Canada as MRI for:

• Diagnostic imaging for various conditions including epilepsy

Approved in Japan as MRI for:

• Diagnostic imaging for various conditions including epilepsy

Approved in China as MRI for:

• Diagnostic imaging for various conditions including epilepsy

Approved in Switzerland as MRI for:

• Diagnostic imaging for various conditions including epilepsy

Who Is Running the Clinical Trial?

Wayne State University

Lead Sponsor

Trials

318

Recruited

111,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

New advancements in magnetic resonance imaging (MRI) techniques are enhancing the ability to investigate and understand epilepsy in patients, making MRI a more valuable tool in clinical settings.

Techniques like magnetic resonance spectroscopy and functional MRI are not only providing critical clinical information but also uncovering fundamental insights into the mechanisms of epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance and functional magnetic resonance imaging: tools for the study of human epilepsy. Kuzniecky, R.[2019]

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]

MRI is the preferred neuroimaging technique for evaluating patients with epilepsy due to its ability to provide detailed structural information.

Functional imaging techniques, such as MR spectroscopy and PET, enhance the understanding of the epileptic substrate and its functional status, suggesting that MRI-based methods could become more central in cost-effective patient evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroimaging in epilepsy. Sitoh, YY., Tien, RD.[2019]

Over a 10-year period, the FDA received 1568 reports of adverse events related to magnetic resonance (MR) systems, with 1548 reports analyzed, highlighting the importance of monitoring safety in MR imaging.

The most common serious injuries reported were thermal events, accounting for 59% of cases, followed by mechanical events (11%), projectile events (9%), and acoustic events (6%), indicating specific risks associated with MR environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI-related FDA adverse event reports: A 10-yr review. Delfino, JG., Krainak, DM., Flesher, SA., et al.[2020]

Magnetic resonance (MR) imaging is considered biologically safe, with no convincing evidence of long-term harmful effects from the radiation and magnetic fields used, including radio-frequency radiation and static magnetic fields.

However, MR imaging poses significant hazards, such as severe injuries from strong magnetic fields affecting ferromagnetic objects and RF burns from induced currents in conductive loops, highlighting the need for thorough safety education and patient screening in MR imaging facilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The AAPM/RSNA physics tutorial for residents. MR imaging safety considerations. Radiological Society of North America. Price, RR.[2011]

MRI is generally safe for humans, even with repeated exposure, but certain components can cause temporary inconveniences or severe accidents if safety protocols are not followed.

The article reviews reported MRI accidents, explaining their mechanisms and emphasizing the importance of strict safety measures to prevent serious adverse effects, including potential fatalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Risks associated with MRI: safety rules, incidents, and accidents]. de Kerviler, E., de Bazelaire, C., Mathieu, O., et al.[2019]

In a study analyzing 16,749 pediatric MRI studies, the overall rate of safety reports was found to be 0.52%, indicating a relatively low incidence of safety issues in this population.

Younger patients (under 6 years), those requiring sedation, and inpatients had higher rates of safety reports, suggesting that these groups are at greater risk and may benefit from targeted safety interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of quality improvement areas in pediatric MRI from analysis of patient safety reports. Jaimes, C., Murcia, DJ., Miguel, K., et al.[2018]

MRI is crucial for diagnosing epilepsy, especially in patients with therapy-resistant focal epilepsy who may need surgery, as it provides detailed images of brain structures.

Advanced MRI techniques, such as diffusion tensor imaging and MR spectroscopy, enhance the ability to differentiate types of epilepsy and identify specific brain abnormalities, making them valuable tools in treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Magnetic resonance measuring and analitic methods in epilepsy]. Barsi, P.[2011]

MRI is superior to CT and teleradiographic techniques for evaluating and managing epilepsy and functional neurological disorders, allowing for more precise placement of electrodes in critical brain structures like the amygdala and hippocampus.

MRI can detect low-grade brain tumors that CT scans might miss, enabling targeted biopsies or excisions using MRI-guided stereotactic techniques, which can improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging in the assessment and surgical management of epilepsy and functional neurological disorders. Maxwell, RE., Gates, JR., McGeachie, R.[2019]

Recent advancements in magnetic resonance (MR) technology have led to stronger magnetic fields and improved safety features, but most MR-related injuries and fatalities are due to non-compliance with safety guidelines.

To enhance safety in MR environments, it is crucial to update and revise safety information regarding biological effects and the compatibility of biomedical implants and devices with current MR technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR procedures: biologic effects, safety, and patient care. Shellock, FG., Crues, JV.[2008]

Recent advancements in MRI technology, such as higher capacity gradient systems and multiple receiver coils, enhance the quality of brain imaging for epilepsy diagnosis and research.

New pulse sequences, including fast spin-echo techniques and fluid-attenuation inversion recovery (FLAIR), improve the specificity and effectiveness of MRI in identifying brain abnormalities associated with epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New technical developments in magnetic resonance imaging of epilepsy. Riederer, SJ., Jack, CR., Grimm, RC., et al.[2019]

Recent advances in magnetic resonance imaging (MRI) techniques, such as voxel-based analysis and magnetic resonance spectroscopy, enhance the ability to identify and study brain lesions associated with epilepsy.

High field strength MRI and new pulse sequences improve functional imaging, allowing for better understanding of neuronal activity and developmental epilepsy, which could lead to more effective treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New techniques of structural and functional MRI]. Rodrigo, S., Oppenheim, C., Jissendi, P., et al.[2008]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7729725/

Evaluation of Magnetic Resonance (MR) Findings in ... This study aims to evaluate the outcome of magnetic resonance imaging in determining the etiology in patients with refractory epilepsy and to reveal pathologies ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1053811924004051

Structural and functional alterations in MRI-negative drug- ... In this study, we assessed structural and functional brain alterations in patients with DRE and drug-sensitive epilepsy (DSE) by analyzing whole ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/epi.18145

Imaging blood–brain barrier dysfunction in drug‐resistant ... We scanned 50 drug-resistant epilepsy (DRE) patients and 58 control participants from four global specialized epilepsy centers using DCE-MRI.

4. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/798793

Characteristics and Surgical Outcomes of Patients With ... Conclusions Patients with epilepsy who are MRI− can be successfully treated with surgery. Improved sensitivity of MRI will improve the outcomes of presurgically ...

5. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2023.1163111/full

Functional and effective connectivity analysis of drug ... We propose using resting-state functional magnetic resonance imaging (rs-fMRI) data to characterize connectivity patterns in drug-resistant epilepsy.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2666459325000800

A review of neuroimaging in epilepsy: Diagnostic strategies ... Navigating neural landscapes: a comprehensive review of magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) applications in epilepsy.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02531880

Study Details | NCT02531880 | Investigation of Blood-Brain ... The primary outcomes are (1) description of the safety profile of mangafodipir administration in patients with epilepsy, and (2) evaluation of the utility of ...

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK581149/

Magnetic resonance imaging scan to detectrelevant ... - NCBI The aim of this review is to assess how well MRI performns in detecting brain lesions or other relevant abnormalities in people with epilepsy.

9. sciencedirect.com sciencedirect.com/science/article/pii/S1878875024020904

Accuracy, Effectiveness, and Safety of Robot-Assisted ... Robot-assisted LITT offers high precision, positive seizure outcomes, and minimal complications, comparable to nonrobotic methods, and is suitable for treating ...

10. neurology.org neurology.org/doi/10.1212/WNL.0000000000213921

Ultra-High Field 7T MRI in a Drug-Resistant Pediatric ... 7T MRI in children with epilepsy is well tolerated and associated with a 23% improvement in lesion detection, directly affecting clinical management and ...