MRI + iEEG for Epilepsy
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: University of Pennsylvania
Disqualifiers: Pregnancy, Metal implants, Claustrophobia, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Upon successful completion of this study, the investigators expect the study's contribution to be the development of noninvasive imaging biomarkers to predict IEEG functional dynamics and epilepsy surgical outcomes. Findings from the present study may inform current and new therapies to map and alter seizure spread, and pave the way for less invasive, better- targeted, patient-specific interventions with improved surgical outcomes. This research is relevant to public health because over 20 million people worldwide suffer from focal drug-resistant epilepsy and are potential candidates for cure with epilepsy surgical interventions.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, since the trial is for patients with medication-refractory epilepsy, it might be assumed that you can continue your current epilepsy medications.
What data supports the effectiveness of the treatment MRI + iEEG for Epilepsy?
Research shows that using 7 Tesla MRI, which provides clearer images of the brain, can detect more abnormalities in epilepsy patients compared to standard MRI. This improved detection can help in planning surgeries and potentially lead to better outcomes for patients with epilepsy.
12345Is it safe to use MRI with intracranial EEG for epilepsy?
Studies have shown that using MRI with intracranial EEG (iEEG) at 1.5T and 3T is generally safe, with no significant risks like electrode movement or dangerous heating, as long as specific safety guidelines are followed.
16789How does the MRI + iEEG treatment for epilepsy differ from other treatments?
The MRI + iEEG treatment for epilepsy is unique because it combines intracranial electroencephalography (iEEG) with functional magnetic resonance imaging (fMRI) to detect smaller brain activity changes that are not visible with standard scalp EEG-fMRI. This approach helps to better understand the brain mechanisms involved in seizures, offering a more detailed view than traditional methods.
1671011Eligibility Criteria
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.Inclusion Criteria
You are planning to have electrodes placed in your brain for EEG testing.
I am believed to have epilepsy originating in the temporal lobe.
My epilepsy does not improve with medication.
Exclusion Criteria
Clinical features that typically preclude the use of IEEG (e.g. pregnancy)
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.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Pre-implant Imaging
Patients undergo diffusion tensor imaging (DTI) and resting-state functional MRI (rsfMRI) prior to stereotactic IEEG
4 weeks
2 visits (in-person)
IEEG Monitoring
Patients undergo stereotactic IEEG to map seizure onset and propagation
4-6 weeks
Inpatient monitoring
Follow-up
Participants are monitored for safety and effectiveness after IEEG monitoring and potential surgical intervention
8 weeks
2 visits (in-person)
Participant Groups
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of PennsylvaniaPhiladelphia, PA
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Who Is Running the Clinical Trial?
University of PennsylvaniaLead Sponsor
Medical University of South CarolinaCollaborator
References
Intracranial EEG-fMRI analysis of focal epileptiform discharges in humans. [2012]Combining intracranial electroencephalography (iEEG) with functional magnetic resonance imaging (fMRI) is of interest in epilepsy studies as it would allow the detection of much smaller interictal epileptiform discharges than can be recorded using scalp EEG-fMRI. This may help elucidate the spatiotemporal mechanisms underlying the generation of interictal discharges. To our knowledge, iEEG-fMRI has never been performed at 3 Tesla (3T) in humans. We report our findings relating to spike-associated blood oxygen level-dependent (BOLD) signal changes in two subjects.
Utility of 7 Tesla Magnetic Resonance Imaging in Patients With Epilepsy: A Systematic Review and Meta-Analysis. [2021]Objective: 7 Tesla magnetic resonance imaging (MRI) enables high resolution imaging and potentially improves the detection of morphologic abnormalities in patients with epilepsy. However, its added value compared with conventional 1.5T and 3.0T MRI is unclear. We reviewed the evidence for the use of 7 Tesla MRI in patients with epilepsy and compared the detection rate of focal lesions with clinical MRI. Methods: Clinical retrospective case studies were identified using the indexed text terms "epilepsy" AND "magnetic resonance imaging" OR "MR imaging" AND "7T" OR "7 Tesla" OR "7T" in Medline (2002-September 1, 2020) and Embase (1999-September 1, 2020). The study setting, MRI protocols, qualitative, and quantitative assessment were systematically reviewed. The detection rate of morphologic abnormalities on MRI was reported in each study in which surgery was used as the reference standard. Meta-analyses were performed using a univariate random-effects model in diagnostic performance studies with patients that underwent both 7T MRI and conventional MRI. Results: Twenty-five articles were included (467 patients and 167 healthy controls) consisting of 10 case studies, 10 case-control studies, 4 case series, and 1 cohort study. All studies included focal epilepsy; 12 studies (12/25, 48%) specified the disease etiology and 4 studies reported focal but non-lesional (MRI-negative on 1.5/3.0T) epilepsy. 7T MRI showed superior detection and delineation of morphologic abnormalities in all studies. In nine comparative studies, 7T MRI had a superior detection rate of 65% compared with the 22% detection rate of 1.5T or 3.0T. Significance: 7T MRI is useful for delineating morphologic abnormalities with a higher detection rate compared with conventional clinical MRI. Most studies were conducted using a case series or case study; therefore, a cohort study design with clinical outcomes is necessary. Classification of Evidence: Class IV Criteria for Rating Diagnostic Accuracy Studies.
7T Epilepsy Task Force Consensus Recommendations on the Use of 7T MRI in Clinical Practice. [2022]Identifying a structural brain lesion on MRI has important implications in epilepsy and is the most important factor that correlates with seizure freedom after surgery in patients with drug-resistant focal onset epilepsy. However, at conventional magnetic field strengths (1.5 and 3T), only approximately 60%-85% of MRI examinations reveal such lesions. Over the last decade, studies have demonstrated the added value of 7T MRI in patients with and without known epileptogenic lesions from 1.5 and/or 3T. However, translation of 7T MRI to clinical practice is still challenging, particularly in centers new to 7T, and there is a need for practical recommendations on targeted use of 7T MRI in the clinical management of patients with epilepsy. The 7T Epilepsy Task Force-an international group representing 21 7T MRI centers with experience from scanning over 2,000 patients with epilepsy-would hereby like to share its experience with the neurology community regarding the appropriate clinical indications, patient selection and preparation, acquisition protocols and setup, technical challenges, and radiologic guidelines for 7T MRI in patients with epilepsy. This article mainly addresses structural imaging; in addition, it presents multiple nonstructural MRI techniques that benefit from 7T and hold promise as future directions in epilepsy. Answering to the increased availability of 7T MRI as an approved tool for diagnostic purposes, this article aims to provide guidance on clinical 7T MRI epilepsy management by giving recommendations on referral, suitable 7T MRI protocols, and image interpretation.
Three-dimensional intracranial EEG monitoring in presurgical assessment of MRI-negative frontal lobe epilepsy. [2021]Magnetic resonance imaging (MRI)-negative epilepsy is associated with poor clinical outcomes prognosis. The present study was aimed to assess whether intracranial 3D interictal and ictal electroencephalography (EEG) findings, a combination of EEG at a different depth, in addition to clinical, scalp EEG, and positron emission tomography-computed tomography (PETCT) data help to predict outcome in a series of patients with MRI-negative frontal lobe epilepsy (FLE) after surgery.Patients with MRI-negative FLE who were presurgically evaluated by 3D-intracranial EEG (3D-iEEG) recording were included. Outcome predictors were compared in patients with seizure freedom (group 1) and those with recurrent seizures (group 2) at least 24 months after surgery.Forty-seven patients (15 female) were included in this study. MRI was found normal in 38 patients, whereas a focal or regional hypometabolism was observed in 33 cases. Twenty-three patients (48.9%) were seizure-free (Engel class I), and 24 patients (51.1%) continued to have seizures (12 were class II, 7 were class III, and 5 were class IV). Detailed analysis of intracranial EEG revealed widespread (>2 cm) (17.4%:75%; P = 0.01) in contrast to focal seizure onset as well as shorter latency to onset of seizure spread (5.9 ± 7.1 s; 1.4 ± 2.9 s; P = 0.016) and to ictal involvement of brain structures beyond the frontal lobe (21.8 ± 20.3 s; 4.9 ± 5.1 s; P = 0.025) in patients without seizure freedom.The results suggest that presurgical evaluation using 3D-iEEG monitoring lead to a better surgical outcome as seizure free in MRI-negative FLE patients.
Ultra-High Field 7-Tesla Magnetic Resonance Imaging and Electroencephalography Findings in Epilepsy. [2022]Assessment of patients for temporal lobe epilepsy (TLE) surgery requires multimodality input, including EEG recordings to ensure optimal surgical planning. Often EEG demonstrates abnormal foci not detected on 1.5T MRI. Ultra-high field MRI at 7T provides improved resolution of the brain. We investigated the utility of 7T MRI to detect potential anatomical abnormalities associated with EEG changes.
Evaluating the Safety of Simultaneous Intracranial Electroencephalography and Functional Magnetic Resonance Imaging Acquisition Using a 3 Tesla Magnetic Resonance Imaging Scanner. [2022]The unsurpassed sensitivity of intracranial electroencephalography (icEEG) and the growing interest in understanding human brain networks and ongoing activities in health and disease have make the simultaneous icEEG and functional magnetic resonance imaging acquisition (icEEG-fMRI) an attractive investigation tool. However, safety remains a crucial consideration, particularly due to the impact of the specific characteristics of icEEG and MRI technologies that were safe when used separately but may risk health when combined. Using a clinical 3-T scanner with body transmit and head-receive coils, we assessed the safety and feasibility of our icEEG-fMRI protocol.
Feasibility of an intracranial EEG-fMRI protocol at 3T: risk assessment and image quality. [2012]Integrating intracranial EEG (iEEG) with functional MRI (iEEG-fMRI) may help elucidate mechanisms underlying the generation of seizures. However, the introduction of iEEG electrodes in the MR environment has inherent risk and data quality implications that require consideration prior to clinical use. Previous studies of subdural and depth electrodes have confirmed low risk under specific circumstances at 1.5T and 3T. However, no studies have assessed risk and image quality related to the feasibility of a full iEEG-fMRI protocol. To this end, commercially available platinum subdural grid/strip electrodes (4×5 grid or 1×8 strip) and 4 or 6-contact depth electrodes were secured to the surface of a custom-made phantom mimicking the conductivity of the human brain. Electrode displacement, temperature increase of electrodes and surrounding phantom material, and voltage fluctuations in electrode contacts were measured in a GE Discovery MR750 3T MR scanner during a variety of imaging sequences, typical of an iEEG-fMRI protocol. An electrode grid was also used to quantify the spatial extent of susceptibility artifact. The spatial extent of susceptibility artifact in the presence of an electrode was also assessed for typical imaging parameters that maximize BOLD sensitivity at 3T (TR=1500 ms; TE=30 ms; slice thickness=4mm; matrix=64×64; field-of-view=24 cm). Under standard conditions, all electrodes exhibited no measurable displacement and no clinically significant temperature increase (2.0°C) that in some cases exceeded 10°C. Induced voltages in the frequency range that could elicit neuronal stimulation (
Feasibility of simultaneous intracranial EEG-fMRI in humans: a safety study. [2022]In epilepsy patients who have electrodes implanted in their brains as part of their pre-surgical assessment, simultaneous intracranial EEG and fMRI (icEEG-fMRI) may provide important localising information and improve understanding of the underlying neuropathology. However, patient safety during icEEG-fMRI has not been addressed. Here the potential health hazards associated with icEEG-fMRI were evaluated theoretically and the main risks identified as: mechanical forces on electrodes from transient magnetic effects, tissue heating due to interaction with the pulsed RF fields and tissue stimulation due to interactions with the switched magnetic gradient fields. These potential hazards were examined experimentally in vitro on a Siemens 3 T Trio, 1.5 T Avanto and a GE 3 T Signa Excite scanner using a Brain Products MR compatible EEG system. No electrode flexion was observed. Temperature measurements demonstrated that heating well above guideline limits can occur. However heating could be kept within safe limits (
Clinical safety of intracranial EEG electrodes in MRI at 1.5 T and 3 T: a single-center experience and literature review. [2021]Intracranial electroencephalography (EEG) can be a critical part of presurgical evaluation for drug resistant epilepsy. With the increasing use of intracranial EEG, the safety of these electrodes in the magnetic resonance imaging (MRI) environment remains a concern, particularly at higher field strengths. However, no studies have reported the MRI safety experience of intracranial electrodes at 3 T. We report an MRI safety review of patients with intracranial electrodes at 1.5 and 3 T.
Subject-level reliability analysis of fast fMRI with application to epilepsy. [2018]Recent studies have applied the new magnetic resonance encephalography (MREG) sequence to the study of interictal epileptic discharges (IEDs) in the electroencephalogram (EEG) of epileptic patients. However, there are no criteria to quantitatively evaluate different processing methods, to properly use the new sequence.
Advances in multimodal neuroimaging: hybrid MR-PET and MR-PET-EEG at 3 T and 9.4 T. [2016]Multi-modal MR-PET-EEG data acquisition in simultaneous mode confers a number of advantages at 3 T and 9.4 T. The three modalities complement each other well; structural-functional imaging being the domain of MRI, molecular imaging with specific tracers is the strength of PET, and EEG provides a temporal dimension where the other two modalities are weak. The utility of hybrid MR-PET at 3 T in a clinical setting is presented and critically discussed. The potential problems and the putative gains to be accrued from hybrid imaging at 9.4 T, with examples from the human brain, are outlined. Steps on the road to 9.4 T multi-modal MR-PET-EEG are also illustrated. From an MR perspective, the potential for ultra-high resolution structural imaging is discussed and example images of the cerebellum with an isotropic resolution of 320 μm are presented, setting the stage for hybrid imaging at ultra-high field. Further, metabolic imaging is discussed and high-resolution images of the sodium distribution are presented. Examples of tumour imaging on a 3 T MR-PET system are presented and discussed. Finally, the perspectives for multi-modal imaging are discussed based on two on-going studies, the first comparing MR and PET methods for the measurement of perfusion and the second which looks at tumour delineation based on MRI contrasts but the knowledge of tumour extent is based on simultaneously acquired PET data.