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Status EpilepticusNCT06017973

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

A study testing MRI scan including arterial spin labelling of the brain, CT perfusion scan of the brain and FDG-PET scan of the brain in people with Status Epilepticus and Ictal-interictal Continuum, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 16 years and olderHealthy volunteers can take part
What is being tested?
MRI scan including arterial spin labelling of the brain, CT perfusion scan of the brain and FDG-PET scan of the brain
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteBelgium
Study dates
1 Oct 2023to 30 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wim Van Paesschen, MD PhD contact

+3216344332

Wim.vanpaesschen@kuleuven.be

Jeroen Gijs, MD contact

+3216344280

Jeroen.gijs@uzleuven.be

Belgium1 site, 1 recruiting

  • University Hospitals Leuven, department of Neurology

    Leuven, 3000

    Wim Van Paesschen, MD, PhD, + 32 16 344280, wim.vanpaesschen@uzleuven.be

    Van Paesschen Wim, MD, PhD

    Recruiting

Other trials in Belgium

About this study

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

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.
Read more

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.

Being tested
MRI scan including arterial spin labelling of the brain, CT perfusion scan of the brain, FDG-PET scan of the brain
Keywords
possible non-convulsive status epilepticus, ictal-interictal continuum, EEG, MRI, FDG-PET, CT perfusion
Medical subject headings
Status Epilepticus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRI scan including arterial spin labelling of the brainDiagnostic test

    Also called Brain perfusion

    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 brainDiagnostic test

    Also called Brain perfusion

    Siemens Naeotom Alpha with quantum technology (photon-counting)

  • FDG-PET scan of the brainDiagnostic test

    Also called Brain metabolism

    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)

Study groups in NCT06017973
Study groupRoleWhat they receive
Possible non-convulsive status epilepticus with ictal-interictal continuum EEG patternsOtherPatients with a possible non-convulsive status epilepticus, according to American Clinical Neurophysiology Criteria (ACNS) (2021).
Receives: 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 subjectsOtherHealthy control subjects.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Day 1

  2. 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).

    Measured: Day 1

  3. 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)

    Measured: Day 1

  4. 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.

    Measured: Day 1

Secondary outcomes (7)

  1. Correlation between SHARPNESS 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 sharpness of ictal-interictal EEG patterns within 30 minutes after injection of FDG. The sharpness of ictal-interictal EEG patterns will be scored semi-quantitatively based on the American Clinical Neurophysiology Criteria (ACNS) (2021)

    Measured: Day 1

  2. Correlation between AMPLITUDE 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 amplitude of ictal-interictal EEG patterns within 30 minutes after injection of FDG. The amplitude of ictal-interictal EEG patterns will be scored semi-quantitatively based on the American Clinical Neurophysiology Criteria (ACNS) (2021)

    Measured: Day 1

  3. Correlation between EVOLUTION 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 evolution of ictal-interictal EEG patterns within 30 minutes after injection of FDG (i.e. static, fluctuating or evolving). The presence of fluctuation and evolution of ictal-interictal EEG patterns will be scored based on the American Clinical Neurophysiology Criteria (ACNS) (2021)

    Measured: Day 1

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

    The investigators will compare interictal burden, defined as a percentage of ictal-interictal EEG patterns during continuous EEG monitoring, in the group with possible non-convulsive status epilepticus WITH hypermetabolism/hyperperfusion versus the group with possible non-convulsive status epilepticus WITHOUT hypermetabolism/hyperperfusion

    Measured: Day 7

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

    The investigators will document all changes in antiseizure medication and compare these in the group with possible non-convulsive status epilepticus WITH hypermetabolism/hyperperfusion versus the group with possible non-convulsive status epilepticus WITHOUT hypermetabolism/hyperperfusion

    Measured: Day 30

  6. Functional imaging in possible non-convulsive status epilepticus and OUTCOME

    The investigators will compare modified rankin scale (mRS) (0: no symptoms, 1: no significant disability, 2: slight disability, 3: moderate disability, 4: moderately severe disability, 5: severe disability and 6: death) at 7 days in the group with possible non-convulsive status epilepticus WITH hypermetabolism/hyperperfusion versus the group with possible non-convulsive status epilepticus WITHOUT hypermetabolism/hyperperfusion

    Measured: Day 7

  7. Functional imaging in possible non-convulsive status epilepticus and OUTCOME

    The investigators will compare modified rankin scale (mRS) (0: no symptoms, 1: no significant disability, 2: slight disability, 3: moderate disability, 4: moderately severe disability, 5: severe disability and 6: death) at 30 days in the group with possible non-convulsive status epilepticus WITH hypermetabolism/hyperperfusion versus the group with possible non-convulsive status epilepticus WITHOUT hypermetabolism/hyperperfusion

    Measured: Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2023
  2. Study start1 Oct 2023
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06017973
Sponsor's protocol ID
S67933
Status last verified
Dec 2024
First submitted
11 Jul 2023
Last updated
27 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Our original imaging and annotated EEG data will be made available to researchers who provide a methodologically sound proposal.

Publications

  • 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.

    PubMed 26336950

  • 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.

    PubMed 33475321

  • 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.

    PubMed 29262437

  • 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.

    PubMed 29139014

  • 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.

    PubMed 29666958

  • 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.

    PubMed 27992625

  • 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.

    PubMed 27169855

  • 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.

    PubMed 30635488

  • 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.

    PubMed 27749504

  • 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.

    PubMed 31862478

  • 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.

    PubMed 35393970

Questions about this trial

What is this clinical trial studying?

A study testing MRI scan including arterial spin labelling of the brain, CT perfusion scan of the brain and FDG-PET scan of the brain in people with Status Epilepticus and Ictal-interictal Continuum, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wim Van Paesschen, MD PhD (+3216344332, Wim.vanpaesschen@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06017973, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.

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