The Role of Imaging in the Diagnosis, Management and Prognosis of Possible Non-convulsive Status Epilepticus

NCT06017973 | Recruiting

• 1 other identifier: S67933
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (4)

• Sensitivity of MRI arterial spin labelling, CT perfusion and FDG-PET of the brain to detect hyperperfusion/hypermetabolism in possible non-convulsive status epilepticus

  The investigators will determine which diagnostic test (MRI, CT or FDG-PET) is most sensitive in detecting hyperperfusion/hypermetabolism in possible non-convulsive status epilepticus to confirm a diagnosis of non-convulsive status epilepticus

  Day 1

• Correlation between FREQUENCY of ictal-interictal EEG patterns within 30 minutes after FDG-PET injection and standardised uptake value on FDG-PET.

  The investigators will assess the correlation between standardised uptake value of the cerebral hypermetabolic region and the frequency of ictal-interictal EEG patterns within 30 minutes after injection of FDG. The frequency of ictal-interictal EEG patterns will be scored semi-quantitatively based on the American Clinical Neurophysiology Criteria (ACNS) criteria (2021).

  Day 1

• Correlation between PREVALENCE of ictal-interictal EEG patterns on EEG within 30 minutes after FDG-PET injection and standardised uptake value on FDG-PET.

  The investigators will assess the correlation between standardised uptake value of the cerebral hypermetabolic region and the prevalence of ictal-interictal EEG patterns within 30 minutes after injection of FDG. The prevalence of ictal-interictal EEG patterns will be scored semi-quantitatively based on the American Clinical Neurophysiology Criteria (ACNS) (2021)

  Day 1

• The seizure freedom of patients with hypermetabolism compared to those with hypometabolism within 24 hours after undergoing an FDG-PET scan.

  The investigators will assess the seizure freedom of patients in the hypermetabolic vs hypometabolic group. Patients will receive video EEG-monitoring for 24 hours after FDG-PET. Seizures will be defined according to current American Clinical Neurophysiology Criteria (ACNS) (2021) based on electrographic and clinical data. Hypermetabolism/hypometabolism will be qualitatively scored by a trained nuclearist.

  Day 1

Secondary Outcomes (7)

• Correlation between SHARPNESS of ictal-interictal EEG patterns on EEG within 30 minutes after FDG-PET injection and standardised uptake value on FDG-PET.

  Day 1

• Correlation between AMPLITUDE of ictal-interictal EEG patterns within 30 minutes after FDG-PET injection and standardised uptake value on FDG-PET

  Day 1

• Correlation between EVOLUTION of ictal-interictal EEG patterns on EEG within 30 minutes after FDG-PET injection and standardised uptake value on FDG-PET.

  Day 1

• Functional imaging in possible non-convulsive status epilepticus and INTERICTAL BURDEN

  Day 7

• Functional imaging in possible non-convulsive status epilepticus and ANTISEIZURE MEDICATION (ASM)

  Day 30

Study Arms (2)

Possible non-convulsive status epilepticus with ictal-interictal continuum EEG patterns

OTHER

Patients with a possible non-convulsive status epilepticus, according to American Clinical Neurophysiology Criteria (ACNS) (2021).

Diagnostic Test: MRI scan including arterial spin labelling of the brain; Diagnostic Test: CT perfusion scan of the brain; Diagnostic Test: FDG-PET scan of the brain

Healthy control subjects

OTHER

Healthy control subjects.

Diagnostic Test: MRI scan including arterial spin labelling of the brain; Diagnostic Test: CT perfusion scan of the brain; Diagnostic Test: FDG-PET scan of the brain

Interventions

MRI scan including arterial spin labelling of the brain DIAGNOSTIC_TEST

Arterial Spin Labelling sequence, T2-weighted FLAIR images and T1-weighted images and diffusion weighted imaging sequence will be recorded

Also known as: Brain perfusion

Healthy control subjects; Possible non-convulsive status epilepticus with ictal-interictal continuum EEG patterns

CT perfusion scan of the brain DIAGNOSTIC_TEST

Siemens Naeotom Alpha with quantum technology (photon-counting)

Also known as: Brain perfusion

Healthy control subjects; Possible non-convulsive status epilepticus with ictal-interictal continuum EEG patterns

FDG-PET scan of the brain DIAGNOSTIC_TEST

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)

Also known as: Brain metabolism

Healthy control subjects; Possible non-convulsive status epilepticus with ictal-interictal continuum EEG patterns

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven, department of Neurology

Leuven, 3000, Belgium

RECRUITING

Related Publications (11)

• 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.

  PMID: 26336950 BACKGROUND

• 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.

  PMID: 33475321 BACKGROUND

• 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.

  PMID: 29262437 BACKGROUND

• 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.

  PMID: 29139014 BACKGROUND

• 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.

  PMID: 29666958 BACKGROUND

• 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.

  PMID: 27992625 BACKGROUND

• 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.

  PMID: 27169855 BACKGROUND

• 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.

  PMID: 30635488 BACKGROUND

• 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.

  PMID: 27749504 BACKGROUND

• 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.

  PMID: 31862478 BACKGROUND

• 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.

  PMID: 35393970 BACKGROUND

MeSH Terms

Conditions

Status Epilepticus

Interventions

Cerebrovascular Circulation

Condition Hierarchy (Ancestors)

Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Circulation; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Wim Van Paesschen, MD PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wim Van Paesschen, MD PhD

CONTACT

+3216344332; Wim.vanpaesschen@kuleuven.be

Jeroen Gijs, MD

CONTACT

+3216344280; Jeroen.gijs@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: August 30, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: data will be made available after publication of our results. There is no end date.
• Access Criteria: Proposals should be directed to Jeroen.gijs@uzleuven.be. To gain access, data requestors will need to sign a data access agreement.

Locations

BE (1)