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Continuous Video EEG Monitoring in Acute Paediatric Ischaemic Stroke

Continuous Video EEG Monitoring in Acute Paediatric Ischaemic Stroke - describing Frequency and Predictors of subclinical and clinical Seizures

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12618000454279
Enrollment
25
Registered
2018-03-28
Start date
2018-07-01
Completion date
2020-07-01
Last updated
2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

There is a retrospective and prospective component to the study. Retrospective patients will be identified through the LCCH clinical stroke database, the Paediatric Intensive Care Unit database and a hospital ICD code search. Appropriate data will be collected and interpreted retrospectively. No additional Video-EEg monitoring will occur. The patients will be followed (neurovascular outpatient clinic and the Queensland Paediatric Rehabilitation Service). This will mainly include standard outpatient appointments. Outcome measures will include the Paediatric Stroke Outcome Measure (PSOM), development of epilepsy and standardized speech and language and cognitive assessments. Outcome will also be comparative to allow for possible baseline developmental delay. Prospective patients will be notified to the study team by neurology, neurosurgery, the emergency department or the paediatric intensive care unit. Study duration will be 2 years. Retrospective patients will be identified from the 2 years preceding the study start date. Follow up is planned for the usual stroke clinic care and for 5 and 10 years. For prospective patients, Video EEG monitoring will occur alongside standard paediatric stroke care. Stroke management will be based on the Australian Paediatric Stroke Guidelines (currently in draft format). Duration of video EEG monitoring will be a minimum of 24hrs. Standardised data will also be collected on all patients with ischaemic stroke over the 2-year study period. The treating clinician will use their discretion to delay or remove the video EEG monitoring if it impedes standard clinical care. The decision whether or not to treat sub-clinical and clinical seizures is at the discretion of the treating clinician however guidance is provided in the Australian Paediatric Stroke Guidelines. Acute neuroimaging (MRI brain) will be reported as per current clinical practice. For study purposes, a second paediatric radiologist will review the imaging. This radiologist will be blinded to the occurrence of clinical or sub-clinical seizures. Neuroimaging analysis will include stroke type and location, presence or absence of haemorrhage and vascular imaging analysis. Where possible volumetric analysis will be performed. Stroke severity will be assessed based the pedNIHSS (Pediatric National Institute of Health Stroke Scale) in concordance with the Australian Paediatric Stroke Guidelines. For the retrospective component of the study the PedNIHSS will be applied retrospectively. Follow-up (outpatient clinic setting) will occur through the neurovascular outpatient clinic and the Queensland Paediatric Rehabilitation Service. Outcome measures will include the Paediatric Stroke Outcome Measure (PSOM), development of epilepsy and standardized speech and language and cognitive assessments. Patients will be treated as per usual standard of care and the only difference for prospective patients will be the duration of the Video-EEG monitoring.

Interventions

The cEEG will commence within 48 hours of study enrolment and within 10 days of stroke onset. The cEEG will be set-up by trained hospital neuroscientists, as per standard hospital procedure. Duration of video EEG monitoring will be a minimum of 24hrs. Acute neuroimaging will be reported as per current clinical practice. For study purposes, a second paediatric radiologist will review the original imaging (MRI, CT or ultrasound). This radiologist will be blinded to the occurrence of clinical or

The cEEG will commence within 48 hours of study enrolment and within 10 days of stroke onset. The cEEG will be set-up by trained hospital neuroscientists, as per standard hospital procedure. Duration of video EEG monitoring will be a minimum of 24hrs. Acute neuroimaging will be reported as per current clinical practice. For study purposes, a second paediatric radiologist will review the original imaging (MRI, CT or ultrasound). This radiologist will be blinded to the occurrence of clinical or sub-clinical seizures. Neuroimaging analysis by the study radiologist will include infarct laterality (right, left, bilateral), location (anterior, middle, or posterior cerebral artery territories), tissue involved (cortex, white matter, basal ganglia), presence or absence of haemorrhage and vascular imaging analysis. Arterial occlusion will be defined as a hyperdense MCA sign on the initial CT scan or as an arterial “cutoff ” of on magnetic resonance angiography or computerized tomographic angiography. All electronically available scans will be further scored with the modified pediatric version of the Alberta Stroke Program Early Computed Tomography Score (modified PedASPECTS, range 0 to 30), a validated method for estimating infarct volume. Evidence of mass effect including sulcal effacement, ventricular compression, cistern effacement, midline shift, and herniation will also be documented. Acute stroke severity will be assessed based the pedNIHSS (Pediatric National Institute of Health Stroke Scale) in accordance with the Australian Paediatric Stroke Guidelines (clinical practice recommendations). Other clinical scores will include the Functional status score and/or Modified Glascow outcome scale to assess function on discharge from PICU and/or hospital. Demographic (age, gender, ethnicity), anthropometric data (height, weight, head circumference) and standard clinical data will also be collected, “Standard” clinical data includes medical history (including past medical history, history of presentation and family medical history), physical examination findings (including observations such as Glascow coma scale score, blood pressure, heart rate, pulse oximetry), investigation results (laboratory data, echocardiography and electrocardiography) and treatment provided. Clinical data will be obtained from the hospital electronic medical records. Investigations other than cEEG will be performed solely on a clinical basis. Follow-up Clinic visit assessments at 3, 6, 12, 18 and 24 months post stroke may include (some assessments will be age dependent): - Standard clinical assessment (review of history, treatment, physical examination) - Paediatric Stroke Outcome Measure (PSOM).10 This a validated tool to measure neurological outcome following stroke. It is based on a physical assessment performed by a clinician. - Functional Status Score (FSS) - Pediatric Cerebral Performance Category (PCPC) or Pediatric Overall Performance Category (POPC) - Epilepsy/seizure questionnaire A Neuropsychological assessment and parent questionnaires will be performed at 12 and 24 months post-stroke. The type of assessment or questionnaire will be made by the neuropsychologist (OL) as this will vary depending on the age of the patient and clinical symptoms. Neuropsychological assessments may include: - Wechsler Intelligence Scale for Children (WISC-V) – 7-16:11; Wechsler Primary and Preschool Scale of Intelligence (WPPSI-IV) 2.6-7; or Bayley scales of Infant Development (<4 years of age), dependent on age, to assess general intelligence - Boston Naming Test (second Edition) – word finding - NEPSY-II subtests - Design Memory (memory), Animal Sorting (EF), and Verbal Fluency (language) - Rey Complex figure test (memory, EF) - Children’s Memory Scale (CMS) – word pairs, story memory subtests (all memory) - Continuous Performance Test (CPT3; attention) – Test of Everyday Attention for Children (TEA-Ch) - Screening tests from the Wechsler Individual Achievement Test (WIAT-III) – reading, spelling, maths - Clinical Evaluation of Language (CELF-5) to assess language Parent Questionnaires may include: - Behaviour Rating Inventory of Executive Functioning (BRIEF; covers EF) - Conners Parent Rating Scale (Attention) - Adaptive Behaviour Assessment System (ABAS-3) - CBCL (Child behaviour checklist) or Strengths and Difficulties Questionnaire – mental health (CBCL is probably stronger here; a bit broader, but SDQ is popular at present). - WeeFIM (interview) - Background questionnaire (including but not limited to re pre-injury diagnoses, therapy inputs), and socioeconomic screen (based on occupation of primary caregiver or income) - The family assessment Device (FAD) – general functioning scale re family functioning - Family Burden or Injury Inventory – family burden

Sponsors

Michaela Waak
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years
Healthy volunteers
No

Inclusion criteria

infants and children diagnosed with acute arterial ischaemic stroke who meet the following inclusion criteria: Age: Children and infants >28 days and < 18 yrs of age infants <29 days of age will only be included if admitted to the PICU The stroke will have occurred within 10 days prior to commencement of video EEG monitoring Ischaemic stroke sub-types include arterial and venous. Background information for all children presenting with AIS will be collected even if cEEG monitoring is not indicated.

Exclusion criteria

Children with haemorrhagic stroke and solely hypoperfusion related brain ischaemia will be excluded

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026