Clinical trial NCT06017973: The Role of Imaging in the Diagnosis, Management and Prognosis of Possible Non-convulsive Status Epilepticus
Official title: The Role of Cerebral Functional, Structural and Spectral Imaging in the Diagnosis, Management and Prognosis of Status Epilepticus: a Prospective Study in Patients with the Ictal-interictal Continuum
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Status Epilepticus
Ictal-interictal Continuum
Positron-emission Tomography
Perfusion Weighted MRI
Perfusion CT
Keywords: possible non-convulsive status epilepticus
ictal-interictal continuum
EEG
MRI
FDG-PET
CT perfusion
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The investigators propose a prospective study of 20 control subjects and 180 consecutive patients with possible non-convulsive status epilepticus (NCSE). The investigators will obtain three functional images of the brain:

1. Fluorodeoxyglucose positron emission tomography (FDG-PET)
2. Perfusion (and structural) magnetic resonance (MR) images
3. Computed tomography (CT) perfusion.

Brain hypermetabolism/hyperperfusion is a strong argument to confirm a diagnosis of non-convulsive status epilepticus.

The aim is to determine which of the three functional imaging techniques is the most sensitive and easy to obtain in the detection of hypermetabolism/hyperperfusion. The investigators will determine which EEG patterns are associated with hypermetabolism/perfusion.

The investigators will further study and describe the management with antiseizure medication and outcome of the group with possible non-convulsive status epilepticus WITH hypermetabolism/hyperperfusion versus the group with possible non-convulsive status epilpticus WITHOUT hypermetabolism/hyperperfusion.

The investigators will make recommendations for an imaging protocol in possible NCSE for widespread use. The aim is to offer guidelines to incorporate imaging in the diagnosis, management and prognosis of NCSE in patients with the ictal-interictal continuum.


Eligibility criteria: Inclusion Criteria:

- The patient has possible non-convulsive status epilepticus with scalp or invasive EEG with ictal-interictal continuum patterns on EEG

Exclusion Criteria:

* The patient has a contra-indication for MRI such as metal implants
* The patient has contrast sensitivity
* The patiensuffers from claustrophobia or cannot tolerate confinement during PET-MRI scanning procedures

Primary outcomes:
measure: Sensitivity of MRI arterial spin labelling, CT perfusion and FDG-PET of the brain to detect hyperperfusion/hypermetabolism in possible non-convulsive status epilepticus
timeFrame: Day 1
measure: Correlation between FREQUENCY of ictal-interictal EEG patterns within 30 minutes after FDG-PET injection and standardised uptake value on FDG-PET.
timeFrame: Day 1
measure: Correlation between PREVALENCE of ictal-interictal EEG patterns on EEG within 30 minutes after FDG-PET injection and standardised uptake value on FDG-PET.
timeFrame: Day 1
measure: The seizure freedom of patients with hypermetabolism compared to those with hypometabolism within 24 hours after undergoing an FDG-PET scan.
timeFrame: Day 1
Secondary outcomes:
measure: Correlation between SHARPNESS of ictal-interictal EEG patterns on EEG within 30 minutes after FDG-PET injection and standardised uptake value on FDG-PET.
timeFrame: Day 1
measure: Correlation between AMPLITUDE of ictal-interictal EEG patterns within 30 minutes after FDG-PET injection and standardised uptake value on FDG-PET
timeFrame: Day 1
measure: Correlation between EVOLUTION of ictal-interictal EEG patterns on EEG within 30 minutes after FDG-PET injection and standardised uptake value on FDG-PET.
timeFrame: Day 1
measure: Functional imaging in possible non-convulsive status epilepticus and INTERICTAL BURDEN
timeFrame: Day 7
measure: Functional imaging in possible non-convulsive status epilepticus and ANTISEIZURE MEDICATION (ASM)
timeFrame: Day 30
measure: Functional imaging in possible non-convulsive status epilepticus and OUTCOME
timeFrame: Day 7
measure: Functional imaging in possible non-convulsive status epilepticus and OUTCOME
timeFrame: Day 30
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven, department of Neurology
Study officials:
affiliation: UZ Leuven
name: Wim Van Paesschen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Trinka E, Cock H, Hesdorffer D, Rossetti AO, Scheffer IE, Shinnar S, Shorvon S, Lowenstein DH. A definition and classification of status epilepticus--Report of the ILAE Task Force on Classification of Status Epilepticus. Epilepsia. 2015 Oct;56(10):1515-23. doi: 10.1111/epi.13121. Epub 2015 Sep 4.
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citation: Rodriguez Ruiz A, Vlachy J, Lee JW, Gilmore EJ, Ayer T, Haider HA, Gaspard N, Ehrenberg JA, Tolchin B, Fantaneanu TA, Fernandez A, Hirsch LJ, LaRoche S; Critical Care EEG Monitoring Research Consortium. Association of Periodic and Rhythmic Electroencephalographic Patterns With Seizures in Critically Ill Patients. JAMA Neurol. 2017 Feb 1;74(2):181-188. doi: 10.1001/jamaneurol.2016.4990.
citation: Struck AF, Westover MB, Hall LT, Deck GM, Cole AJ, Rosenthal ES. Metabolic Correlates of the Ictal-Interictal Continuum: FDG-PET During Continuous EEG. Neurocrit Care. 2016 Jun;24(3):324-31. doi: 10.1007/s12028-016-0245-y.
citation: Subramaniam T, Jain A, Hall LT, Cole AJ, Westover MB, Rosenthal ES, Struck AF. Lateralized periodic discharges frequency correlates with glucose metabolism. Neurology. 2019 Feb 12;92(7):e670-e674. doi: 10.1212/WNL.0000000000006903. Epub 2019 Jan 11.
citation: Venkatraman A, Khawaja A, Bag AK, Mirza M, Szaflarski JP, Pati SBB. Perfusion MRI Can Impact Treatment Decision in Ictal-Interictal Continuum. J Clin Neurophysiol. 2017 Jul;34(4):e15-e18. doi: 10.1097/WNP.0000000000000350.
citation: Gugger JJ, Llinas RH, Kaplan PW. The role of CT perfusion in the evaluation of seizures, the post-ictal state, and status epilepticus. Epilepsy Res. 2020 Jan;159:106256. doi: 10.1016/j.eplepsyres.2019.106256. Epub 2019 Dec 12.
citation: Trinka E, Leitinger M. Management of Status Epilepticus, Refractory Status Epilepticus, and Super-refractory Status Epilepticus. Continuum (Minneap Minn). 2022 Apr 1;28(2):559-602. doi: 10.1212/CON.0000000000001103.