MELD as an Adjunct for SEEG Trajectories

NCT04383028 | Unknown

• 1 other identifier: 19NI10
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Epilepsy is a disorder of the brain which is associated with disabling seizures and affects 100,000 people under 25. Many children with epilepsy also have a learning disability or problems with development. Although better outcomes occur in children who are successfully treated early for their epilepsy, 25% continue to have seizures despite best medical treatment. 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

Conditions

Epilepsy; Epilepsy, Focal; Epilepsy, Refractory

Outcome Measures

Primary Outcomes (1)

• Additional contacts in neurophysiologically defined seizure onset zone

  For each patient, the investigators will assess whether any of the additional electrodes (added as part of the trial to record from detected lesions) were in the neurophysiologically (SEEG) defined seizure onset zone. This will be a dichotomous yes/no outcome for each patient.

  Baseline (During inpatient admission)

Secondary Outcomes (8)

• Pre-implantation confidence

  Baseline (During inpatient admission)

• Number of electrodes added

  Baseline (During inpatient admission)

• Number of electrodes added

  Baseline (During inpatient admission)

• Was a MELD-identified lesion part of the SOZ (and if so how many?)

  Baseline (During inpatient admission)

• Would the SOZ have been identified without MELD?

  Baseline (During inpatient admission)

Study Arms (1)

MELD-assisted SEEG trajectory planning

EXPERIMENTAL

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.

Procedure: MELD algorithm use to aid in the planning of SEEG electrode trajectories

Interventions

MELD algorithm use to aid in the planning of SEEG electrode trajectories PROCEDURE

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.

MELD-assisted SEEG trajectory planning

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients aged 3-18 undergoing SEEG recording as part of the investigation of their epilepsy at Great Ormond Street Hospital for Children.

You may not qualify if:

• Tuberous sclerosis
• Prior resective epilepsy surgery
• Insufficient imaging datasets for the algorithm
• Lack of informed consent

Sponsors & Collaborators

• Great Ormond Street Hospital for Children NHS Foundation Trust: lead

Study Sites (1)

Great Ormond Street Hospital NHS Foundation Trust

London, WC1N 3JH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Epilepsy; Epilepsies, Partial; Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Aswin Chari, MRCS

CONTACT

+447726780817; aswin.chari@gosh.nhs.uk

Martin Tisdall, FRCS

CONTACT

+447726780817; martin.tisdall@gosh.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: May 11, 2020
• Study Start: July 1, 2020
• Primary Completion: April 30, 2022
• Study Completion: May 30, 2022
• Last Updated: November 19, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)