The Role of Imaging in the Diagnosis, Management and Prognosis of Possible Non-convulsive Status Epilepticus
NCT ID: NCT06017973
Last Updated: 2024-12-27
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
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RECRUITING
NA
200 participants
INTERVENTIONAL
2023-10-01
2027-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Possible non-convulsive status epilepticus with ictal-interictal continuum EEG patterns
Patients with a possible non-convulsive status epilepticus, according to American Clinical Neurophysiology Criteria (ACNS) (2021).
MRI scan including arterial spin labelling of the brain
Arterial Spin Labelling sequence, T2-weighted FLAIR images and T1-weighted images and diffusion weighted imaging sequence will be recorded
CT perfusion scan of the brain
Siemens Naeotom Alpha with quantum technology (photon-counting)
FDG-PET scan of the brain
An FDG-PET scan will be acquired on a GE Signa 3T PET-MR scanner. FDG-PET images will be assessed for focal hypermetabolism, including semiquantitative analysis of the maximal standard uptake value (SUVmax) relative to the SUVmax of the pons (SUVr pons)
Healthy control subjects
Healthy control subjects.
MRI scan including arterial spin labelling of the brain
Arterial Spin Labelling sequence, T2-weighted FLAIR images and T1-weighted images and diffusion weighted imaging sequence will be recorded
CT perfusion scan of the brain
Siemens Naeotom Alpha with quantum technology (photon-counting)
FDG-PET scan of the brain
An FDG-PET scan will be acquired on a GE Signa 3T PET-MR scanner. FDG-PET images will be assessed for focal hypermetabolism, including semiquantitative analysis of the maximal standard uptake value (SUVmax) relative to the SUVmax of the pons (SUVr pons)
Interventions
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MRI scan including arterial spin labelling of the brain
Arterial Spin Labelling sequence, T2-weighted FLAIR images and T1-weighted images and diffusion weighted imaging sequence will be recorded
CT perfusion scan of the brain
Siemens Naeotom Alpha with quantum technology (photon-counting)
FDG-PET scan of the brain
An FDG-PET scan will be acquired on a GE Signa 3T PET-MR scanner. FDG-PET images will be assessed for focal hypermetabolism, including semiquantitative analysis of the maximal standard uptake value (SUVmax) relative to the SUVmax of the pons (SUVr pons)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* The patient has contrast sensitivity
* The patiensuffers from claustrophobia or cannot tolerate confinement during PET-MRI scanning procedures
16 Years
ALL
Yes
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Wim Van Paesschen, MD PhD
Role: PRINCIPAL_INVESTIGATOR
UZ Leuven
Locations
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University Hospitals Leuven, department of Neurology
Leuven, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Wim Van Paesschen, MD, PhD
Role: primary
Van Paesschen Wim, MD, PhD
Role: backup
References
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Osman GM, Araujo DF, Maciel CB. Ictal Interictal Continuum Patterns. Curr Treat Options Neurol. 2018 Apr 18;20(5):15. doi: 10.1007/s11940-018-0500-y.
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.
Hirsch LJ, Fong MWK, Leitinger M, LaRoche SM, Beniczky S, Abend NS, Lee JW, Wusthoff CJ, Hahn CD, Westover MB, Gerard EE, Herman ST, Haider HA, Osman G, Rodriguez-Ruiz A, Maciel CB, Gilmore EJ, Fernandez A, Rosenthal ES, Claassen J, Husain AM, Yoo JY, So EL, Kaplan PW, Nuwer MR, van Putten M, Sutter R, Drislane FW, Trinka E, Gaspard N. American Clinical Neurophysiology Society's Standardized Critical Care EEG Terminology: 2021 Version. J Clin Neurophysiol. 2021 Jan 1;38(1):1-29. doi: 10.1097/WNP.0000000000000806. No abstract available.
Cormier J, Maciel CB, Gilmore EJ. Ictal-Interictal Continuum: When to Worry About the Continuous Electroencephalography Pattern. Semin Respir Crit Care Med. 2017 Dec;38(6):793-806. doi: 10.1055/s-0037-1607987. Epub 2017 Dec 20.
Rubinos C, Reynolds AS, Claassen J. The Ictal-Interictal Continuum: To Treat or Not to Treat (and How)? Neurocrit Care. 2018 Aug;29(1):3-8. doi: 10.1007/s12028-017-0477-5.
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.
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.
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.
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.
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.
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.
Other Identifiers
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S67933
Identifier Type: -
Identifier Source: org_study_id