Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
20 participants
INTERVENTIONAL
2020-07-01
2022-05-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
One potential treatment is a neurosurgical operation to remove parts of the brain that generate seizures. A proportion of these children have electrodes inserted into their brains as part of their clinical assessment, termed stereoelectroencephalography (SEEG), to help localise these regions. Subsequent surgery is not always successful - up to 40% of children will have ongoing seizures 5 years after surgery.
The planning of where to place SEEG electrodes relies on experts (neurologists, neurophysiologists and neurosurgeons) using information from multiple sources, which are used to generate hypotheses about where the seizures are coming from. The main components are the patient's magnetic resonance imaging (MRI) scan and video-electroencephalography (EEG) recordings during seizures. Using this information, between 5-18 electrodes are implanted and the recordings continue for 5-15 days in hospital. A focus is identified in about 75% of cases which means that the focus is sometimes missed.
This prospective single arm pilot study aims to assess a new automated lesion detection algorithm, MELD, designed to identify focal cortical dysplasias (the most common pathology associated with focal epilepsy in children) on otherwise 'normal' MRI scans. The investigators will assess whether MELD can be used to improve the targeting of abnormalities in children undergoing SEEG recording at Great Ormond Street Hospital
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The planning of where to place SEEG electrodes currently relies on an expert multidisciplinary team consisting of neurologists, neurophysiologists and neurosurgeons. Information from multiple sources, mainly the patient's magnetic resonance imaging (MRI) scan and video-electroencephalography (EEG) recording, are used to generate hypotheses about the location of the clinical seizure onset zone (SOZ). Using this information, between 5-18 electrodes are implanted and the recordings continue for 5-15 days in hospital. In a retrospective review of 75 SEEG cases, a focus was identified in about 77% of cases which means that the focus is sometimes missed.
This prospective single arm pilot study to aims assess a new automated lesion detection algorithm, MELD, designed to identify focal cortical dysplasias (the most common pathology associated with focal epilepsy in children) on otherwise 'normal' MRI scans.1 This algorithm was developed in-house by collaborators in this grant application. In our subsequent retrospective study of 34 SEEG patients, the algorithm colocalised with the SEEG-defined SOZ in 62% of all patients with a cortical SOZ and 86% of all patients with a histologically confirmed focal cortical dysplasia.2 Importantly, there were 3 patients whose SOZ was thought to be missed on SEEG who had MELD-identified lesions that were not implanted. In order to improve the algorithm, investigators have subsequently launched an international multicentre collaboration (https://meldproject.github.io//) to increase the number of lesion positive and control scans available to train the algorithm, improving its sensitivity, specificity and accuracy. This project has gathered over 550 lesional and 350 control scans, which will be used to train the algorithm. The prospective MAST Trial is therefore the ideal next step in the evaluating the utility of the MELD algorithm in identifying abnormal areas of the brain that could be responsible for seizures.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MELD-assisted SEEG trajectory planning
Following routine clinical planning, the MELD algorithm will be run on the enrolled patient's scans. Up to 3 extra electrodes may be used to target lesion clusters identified by the algorithm such that the investigators will record from the top 3 clusters, with the aim of improving the rate of identification of a focal seizure onset zone in patients undergoing SEEG.
MELD algorithm use to aid in the planning of SEEG electrode trajectories
During the routine SEEG planning meetings, the planning of SEEG trajectories, including the number and location of electrodes, will follow the usual clinical pathway and be planned according to the expertise of the attending neurosurgeon, neurophysiologist and neurologist at the multidisciplinary team meeting. Once the trajectories have been planned, anonymised scans for each patient (linked to them via a unique study ID) will be run through the MELD classifier and the top 3 MELD identified lesion clusters will be considered for further implantation.
These top 3 MELD classifier identified clusters will then be merged with the existing clinical plan to assess if each of the clusters are already being sampled by an SEEG electrode. If there is already an electrode in each lesion, no adjustments will be made. If there are clusters that are not being recorded from, and it is technically possible, extra electrodes (up to 3) will be added to record from these additional locations.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MELD algorithm use to aid in the planning of SEEG electrode trajectories
During the routine SEEG planning meetings, the planning of SEEG trajectories, including the number and location of electrodes, will follow the usual clinical pathway and be planned according to the expertise of the attending neurosurgeon, neurophysiologist and neurologist at the multidisciplinary team meeting. Once the trajectories have been planned, anonymised scans for each patient (linked to them via a unique study ID) will be run through the MELD classifier and the top 3 MELD identified lesion clusters will be considered for further implantation.
These top 3 MELD classifier identified clusters will then be merged with the existing clinical plan to assess if each of the clusters are already being sampled by an SEEG electrode. If there is already an electrode in each lesion, no adjustments will be made. If there are clusters that are not being recorded from, and it is technically possible, extra electrodes (up to 3) will be added to record from these additional locations.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Prior resective epilepsy surgery
* Insufficient imaging datasets for the algorithm
* Lack of informed consent
3 Years
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Great Ormond Street Hospital for Children NHS Foundation Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Great Ormond Street Hospital NHS Foundation Trust
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Aswin Chari, MRCS
Role: primary
Martin Tisdall, PhD
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
19NI10
Identifier Type: -
Identifier Source: org_study_id