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

Trial Summary

What is the purpose of this trial?

This project will test the accuracy of a novel diffusion-weighted magnetic resonance imaging (DWMRI) approach using a deep convolutional neural network (DCNN) to predict an optimal resection margin for pediatric epilepsy surgery objectively. Its primary goal is to minimize surgical risk probability (i.e., functional deficit) and maximize surgical benefit probability (i.e., seizure freedom) by precisely localizing eloquent white matter pathways in children and adolescents with drug-resistant focal epilepsy. This new imaging approach, which will acquire a DWMRI scan before pediatric epilepsy surgery in about 10 minutes without contrast administration (and also without sedation even in young children), can be readily applied to improve preoperative benefit-risk evaluation for pediatric epilepsy surgery in the future. The investigators will also study how the advanced DWMRI-DCNN connectome approach can detect complex signs of brain neuronal reorganization that help improve neurological and cognitive outcomes following pediatric epilepsy surgery. This new imaging approach could benefit targeted interventions in the future to minimize neurocognitive deficits in affected children. All enrolled subjects will undergo advanced brain MRI and neurocognitive evaluation to achieve these goals. The findings of this project will not guide any clinical decision-making or clinical intervention until the studied approach is thoroughly validated.

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 data supports the effectiveness of the treatment Brain Magnetic Resonance Imaging (MRI) for epilepsy?

Recent advances in MRI techniques, such as functional MRI and diffusion imaging, have improved the ability to identify and evaluate epileptogenic lesions, which are areas in the brain that cause seizures. These developments help in the presurgical evaluation and management of epilepsy, making MRI a crucial tool in diagnosing and planning treatment for patients with epilepsy. ^{1 2 3 4 5}

Is MRI safe for humans?

MRI is generally considered safe for humans, with no long-term harmful effects from the magnetic fields and radio waves used. However, there are risks if safety guidelines are not followed, such as interference with electronic devices like pacemakers and potential burns from certain equipment. Proper screening and preparation are essential to ensure safety during MRI procedures. ^{6 7 8 9 10}

How is the treatment 'Advanced MRI Techniques for Epilepsy' different from other treatments for epilepsy?

Advanced MRI techniques for epilepsy are unique because they provide detailed images of the brain's structure and function, helping to identify the specific areas involved in seizures. These techniques, such as diffusion-weighted imaging and MR spectroscopy, offer insights into the brain's microanatomy and chemical composition, which can aid in diagnosis and treatment planning, unlike traditional imaging methods. ^{1 2 5 11 12}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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 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]

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]

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]

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 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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

New technical developments in magnetic resonance imaging of epilepsy. [2019]

2. England pubmed.ncbi.nlm.nih.gov

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

3. Switzerland pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging in the assessment and surgical management of epilepsy and functional neurological disorders. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Proposal for a magnetic resonance imaging protocol for the detection of epileptogenic lesions at early outpatient stages. [2022]

5. Hungary pubmed.ncbi.nlm.nih.gov

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

6. France pubmed.ncbi.nlm.nih.gov

[Risks associated with MRI: safety rules, incidents, and accidents]. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

MRI-related FDA adverse event reports: A 10-yr review. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

MR procedures: biologic effects, safety, and patient care. [2008]

10. Germany pubmed.ncbi.nlm.nih.gov

Identification of quality improvement areas in pediatric MRI from analysis of patient safety reports. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Neuroimaging in epilepsy. [2019]

12. France pubmed.ncbi.nlm.nih.gov

[New techniques of structural and functional MRI]. [2008]