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NCT Number: NCT06017973

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

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.

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Key information

Conditions

Status Epilepticus Ictal-interictal Continuum Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perfusion CT Perfusion Weighted MRI Positron-Emission Tomography Seizures Signs and Symptoms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Leuven, department of Neurology

Leuven, 3000, Belgium

Location status: Recruiting

Location contact

Van Paesschen Wim, MD, PhD

CONTACT

Wim Van Paesschen, MD, PhD

CONTACT

[email protected]

+ 32 16 344280

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Brain perfusion

CT perfusion scan of the brain

Diagnostic Test

Siemens Naeotom Alpha with quantum technology (photon-counting)

Other names: Brain perfusion

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)

Other names: Brain metabolism

Primary outcomes

  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

    Time frame: Day 1

    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

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

    Time frame: Day 1

    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).

  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.

    Time frame: Day 1

    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)

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

    Time frame: Day 1

    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.

Secondary outcomes

  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.

    Time frame: Day 1

    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)

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

    Time frame: Day 1

    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)

  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.

    Time frame: Day 1

    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)

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

    Time frame: Day 7

    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

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

    Time frame: Day 30

    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

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

    Time frame: Day 7

    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

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

    Time frame: Day 30

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Jeroen Gijs, MD

CONTACT

[email protected]

+3216344280

Wim Van Paesschen, MD PhD

CONTACT

[email protected]

+3216344332

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 30, 2023
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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