Noninvasive Imaging for Epilepsy

Recruiting at 1 trial location

Overseen By Aaliyah M HamidullahThiam

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

Must not be taking: Benzodiazepines, Barbiturates, Antidepressants, others

Disqualifiers: Pregnancy, Claustrophobia, Psychiatric disorders, others

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

Compensation: Varies

Number of Visits: 2

700 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve how doctors identify the specific brain areas causing seizures in people with difficult-to-treat epilepsy. It employs advanced imaging techniques like MRI (Magnetic Resonance Imaging) and MEG (Magnetoencephalography) to collect detailed brain activity data before and after surgery. Suitable candidates for this trial are individuals aged 8 and older with epilepsy not controlled by medication and who are being evaluated for surgery. Participants will undergo various brain scans and tests to help researchers understand how these brain areas affect thinking and memory.

As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking advancements in epilepsy care.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications. However, healthy volunteers must not have used centrally acting medications like benzodiazepines, barbiturates, antidepressants, beta-blockers, or drugs for epilepsy or migraine in the past 6 weeks.

What prior data suggests that these imaging techniques are safe for epilepsy evaluation?

Research has shown that the treatments used in this trial are safe. Magnetoencephalography (MEG) is a non-invasive test with no known risks, as it doesn't use radiation or require injections. In the U.S., MEG is approved for epilepsy surgery and brain mapping before operations.

Magnetic resonance imaging (MRI) is also considered safe. It helps identify brain changes related to seizures. For some individuals with implanted devices, MRI can be safe if certain guidelines are followed.

Noninvasive tests before surgery aim to predict seizure freedom without adding neurological risks. One study found that the chance of permanent neurological issues is low, about 2.5%. Overall, patients with epilepsy have well-tolerated these treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores noninvasive imaging techniques like MEG and MRI for evaluating epilepsy. Unlike traditional methods that might require invasive procedures such as surgery or intracranial monitoring, these imaging techniques offer a way to assess brain activity and structure without needing to physically enter the body. This approach not only reduces potential risks and recovery time for patients but also provides detailed insights that can help tailor more effective treatment plans. By using advanced imaging to understand brain function and seizure sources, researchers hope to improve the accuracy and safety of pre-surgical evaluations for epilepsy patients.

What evidence suggests that these imaging techniques are effective for epilepsy?

This trial will use noninvasive imaging techniques, including MRI and MEG, to evaluate epilepsy. Studies have shown that MRI, or Magnetic Resonance Imaging, effectively identifies brain issues causing epilepsy. It is considered the best method for brain imaging because it clearly shows soft tissues and scans from different angles. Research indicates that MEG, or Magnetoencephalography, helps pinpoint the exact location of epilepsy in the brain. This noninvasive technique aids in planning surgeries and can significantly increase the chances of patients being seizure-free after surgery. Noninvasive evaluations before surgery, which include these imaging methods, have led to good results, with many patients experiencing fewer seizures or becoming completely seizure-free. ^{1 6 7 8 9}

Who Is on the Research Team?

Sara K Inati, M.D.

Principal Investigator

National Institute of Neurological Disorders and Stroke (NINDS)

Are You a Good Fit for This Trial?

This trial is for adults and children aged 8 or older with uncontrolled focal epilepsy, who are being evaluated for or have had epilepsy surgery. Participants must be able to consent themselves or through a guardian and cooperate with MRI scans without anesthesia.

Inclusion Criteria

I am 8 years old or older and being evaluated for epilepsy surgery.

Documentation of focal epilepsy based on MRI, EEG, and/or ictal semiology

Patients who had a preoperative structural brain MRI of the type used in this protocol

Exclusion Criteria

Not able or willing to give consent or do not have an appropriate surrogate who can provide consent

I do not have major health issues affecting my brain or nerves.

I haven't taken any central nervous system medications in the last 6 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Presurgical Evaluation

Participants undergo neuropsychological testing and 1-4 MRI sessions to evaluate epileptic foci

Varies

1-4 visits (in-person)

Post-operative Evaluation

Participants undergo additional 1-3 MRI sessions and neuropsychological testing approximately 12 months after surgery

12 months

1-3 visits (in-person)

Follow-up

Participants are monitored for changes in cognitive function and network activity post-surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MEG
• MRI
• Noninvasive Pre-surgical Evaluation

Trial Overview The study aims to improve the detection of epileptic foci using MRI before and after surgery in patients with refractory epilepsy. It also involves creating a database from healthy volunteers for comparison, plus additional brain imaging (MEG) and cognitive testing.

How Is the Trial Designed?

Group I: healthy volunteers Experimental Treatment 2 Interventions

healthy volunteers

Group II: Patients Experimental Treatment 2 Interventions

Patients

MEG is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Magnetoencephalography for:

• Epilepsy diagnosis
• Presurgical evaluation

Approved in European Union as Magnetoencephalography for:

• Epilepsy diagnosis
• Presurgical evaluation
• Neurological disorders

Approved in Canada as Magnetoencephalography for:

• Epilepsy diagnosis
• Presurgical evaluation

Approved in Japan as Magnetoencephalography for:

• Epilepsy diagnosis
• Presurgical evaluation
• Neurological disorders

Who Is Running the Clinical Trial?

National Institute of Neurological Disorders and Stroke (NINDS)

Lead Sponsor

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

Magnetoencephalography (MEG) shows promise as a noninvasive tool for localizing epilepsy, but the current evidence does not strongly support its effectiveness in predicting seizure-free outcomes after surgery, based on a systematic review of 17 studies.

The review highlighted significant variability in sensitivity and specificity of MEG results, indicating that more research is needed to establish a clear relationship between MEG localization and successful surgical resection in epilepsy patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on MEG and its use in the presurgical evaluation of localization-related epilepsy. Lau, M., Yam, D., Burneo, JG.[2018]

Magnetoencephalography (MEG) is now routinely used in clinical settings to accurately localize sources of epileptic spikes, both during seizures and in between them, providing a reliable tool for epilepsy evaluation.

MEG helps to assess the significance of abnormalities found in other imaging techniques, making it a crucial noninvasive method for evaluating candidates for epilepsy surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetoencephalography: clinical application in epilepsy. Knowlton, RC.[2019]

Magnetoencephalography (MEG) has become a routine clinical tool for accurately localizing sources of epileptic spikes, both during seizures and between them, showing high accuracy compared to traditional methods like intracranial EEG.

Despite its effectiveness, MEG faces challenges in detecting complex or deep brain sources, but it remains crucial for evaluating the significance of abnormalities found in other imaging techniques, enhancing noninvasive approaches to epilepsy surgery evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetoencephalography in epilepsy. Knowlton, RC., Shih, J.[2007]

Magnetoencephalography (MEG) is a noninvasive imaging technique that allows for precise localization of brain activity, making it the preferred method for mapping functional areas in the brain, especially in epilepsy patients.

MEG can effectively identify the irritative zone in epilepsy, map critical language areas, and assess language development in children, thus enhancing the evaluation process for epilepsy surgery and other neurological conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetoencephalography (MEG) and magnetic source imaging (MSI). Wheless, JW., Castillo, E., Maggio, V., et al.[2019]

Magnetoencephalography (MEG) is now routinely used in clinical practice to improve the presurgical evaluation of patients with epilepsy and brain tumors, helping to localize brain activity accurately.

Studies indicate that using MEG to localize epileptic discharges can lead to better postsurgical outcomes for epilepsy patients, highlighting its importance in treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical applications of magnetoencephalography. Stufflebeam, SM., Tanaka, N., Ahlfors, SP.[2023]

Magnetoencephalography (MEG) demonstrated a high sensitivity of 90% in detecting interictal epileptiform activity in infants with pharmacoresistant epilepsy, effectively identifying seizure foci even when EEG showed generalized dysfunction in 80% of cases.

In a cohort of 18 infants who underwent surgery, 72% achieved seizure freedom, particularly those with focal spike volumes identified by MEG, highlighting its critical role in the presurgical evaluation and decision-making process for infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetoencephalographic Recordings in Infants: A Retrospective Analysis of Seizure-Focus Yield and Postsurgical Outcomes. Garcia-Tarodo, S., Funke, M., Caballero, L., et al.[2018]

Magnetoencephalography (MEG) is highly effective for presurgical evaluation in epilepsy due to its excellent spatio-temporal resolution, particularly in analyzing interictal spikes.

Combining MEG results with detailed clinical symptomatology enhances the identification of epileptic foci, highlighting the need for integrated epilepsy diagnosis and treatment teams in hospitals to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Magnetoencephalography analysis of epileptic foci]. Imai, K.[2018]

Magnetoencephalography (MEG) is an advanced imaging technique that effectively localizes epileptiform activity in children, showing good correlation with invasive monitoring methods during surgery.

MEG can enhance surgical planning for pediatric epilepsy by accurately mapping critical brain functions and guiding neurosurgeons in selecting the safest approach for treatment, particularly in complex cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of magnetoencephalography in pediatric epilepsy surgery. Grondin, R., Chuang, S., Otsubo, H., et al.[2022]

Pediatric magnetoencephalography (MEG) is a noninvasive technique that can significantly enhance clinical practice and research for infants and young children, particularly in understanding brain activity.

Current pediatric MEG systems are limited, but they hold promise for improving the diagnosis and treatment of conditions like drug-resistant epilepsy, highlighting a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric Magnetoencephalography in Clinical Practice and Research. Papadelis, C., Chen, YH.[2021]

Magnetoencephalography (MEG) is a non-invasive imaging technique that captures the brain's electrical activity through magnetic fields, and when combined with MRI, it forms Magnetic Source Imaging (MSI) which is useful for evaluating epilepsy.

MSI is increasingly utilized in the presurgical assessment of patients with refractory partial epilepsy, helping to accurately localize brain areas associated with epileptic discharges, which can guide surgical planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contribution of magnetic source imaging to the presurgical work-up of patients with refractory partial epilepsy. De Tiège, X., Op de Beeck, M., Bourguignon, M., et al.[2009]

Magnetoencephalography (MEG) plays a crucial role in the clinical evaluation of patients with pharmacoresistant epilepsy, helping to determine who is eligible for epilepsy surgery.

The primary benefit of MEG is that it increases the number of patients who can proceed to surgery, but it should not be used as a reason to deny surgical options to any patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetoencephalography adds to the surgical evaluation process. Stefan, H., Rampp, S., Knowlton, RC.[2011]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10368885/

Magnetoencephalography-based approaches to epilepsy ... The results showed that the SVM classification model achieved an average accuracy of 81.37%, sensitivity of 81.1%, and specificity of 81.54% ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10887328/

Magnetoencephalography (MEG) Data Processing in ... Magnetoencephalography (MEG), a non-invasive neurophysiologic and functional imaging technique, aids epilepsy assessment and surgery planning.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2405844024148724

Application of magnetoencephalography in epilepsy For instance, when MEG results align with stereoelectroencephalography (SEEG), the postoperative seizure-free rate significantly improves.

4. mayoclinic.org mayoclinic.org/medical-professionals/neurology-neurosurgery/news/meg-enhances-precision-of-focal-epilepsy-localization/mac-20568548

MEG enhances precision of focal epilepsy localization The noninvasive test helps target locations for sEEG electrode placement. The highly detailed test results guide treatment options.

5. nature.com nature.com/articles/s41598-024-75370-9

Deep learning based automatic detection and dipole ... Magnetoencephalography (MEG) is an effective tool for the clinical analysis of epilepsy. Neurophysiologists analyze abnormal signals (spikes, ...

6. neurology.ufl.edu neurology.ufl.edu/meg/patient-questions/

Patient questions - UF Neurology - University of Florida MEG is a safe and non-invasive procedure. There are no known risks associated with MEG scans, as it does not use radiation or require the injection of contrast ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4001219/

Magnetoencephalography: Basic principles - PMC MEG currently has two approved indications in the United States, one is for pre-operative brain mapping and the other is for use in epilepsy surgery. MEG ...

8. epilepsy.com epilepsy.com/diagnosis/brain-imaging/magnetoencephalography

MEG MEG (magnetoencephalography) is a noninvasive technique to study brain function. It measures electrical currents in neurons to help find a seizure's source.

9. bcbsm.com bcbsm.com/amslibs/content/dam/public/mpr/mprsearch/pdf/78471.pdf

MEDICAL POLICY - MAGNETOENCEPHALOGRAPHY/ ... The safety and effectiveness of magnetoencephalography and magnetic source imaging have been established. They may be considered useful ...