Clinical trial NCT05864547: Predisposing Factors for Post-stroke Epilepsy
Official title: Predisposing Factors for Post-stroke Epilepsy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post Stroke Epilepsy
Stroke
Epilepsy
Seizures
Keywords: Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Disorders
Vascular Diseases
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2023-05-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: First time stroke patients with capacity to consent and who can undergo MR imaging, admitted to the stroke unit at St. Olavs hospital.

Brief summary: The goal of this observational study is to learn about epilepsy after a stroke (post-stroke epilepsy). The main questions it aims to answer are:

* What make some patients develop epilepsy after a stroke?
* Does sleep have an impact on the development of post-stroke epilepsy?

Participants will undergo:

* Electroencephalography (EEG)
* Magnetic resonance imaging (MRI)
* Polysomnography (only patients)

Blood tests will also be taken. The patient group will be compared to the healthy controls. Researchers will also look into medical records of stroke patients hospitalized at St. Olavs hospital and collect relevant information.

Detailed description: This study aims to study risk factors and clinical factors which might contribute to the development of post-stroke epilepsy. Researchers will look at the volume and size of the stroke-induced brain lesions and analyze inflammation markers. Patients and controls will undergo EEG and MRI. The correlations between sleep and epilepsy after a stroke will also be investigated through polysomnography. Relevant information about for instance age, comorbidities and NIHSS will be collected. Researchers will also collect relevant information from medical records of stroke patients hospitalized at St. Olavs hospital.

Eligibility criteria: Inclusion Criteria:

* First time stroke patients with capacity to consent, admitted to the stroke unit at St. Olavs hospital.
* Modified Rankin Scale (mRS) ≤ 2 before the stroke

Exclusion Criteria:

* Previous stroke or brain surgery
* Traumatic brain injuries
* Neurodegenerative diseases
* Brain tumors
* Epilepsy before the stroke
* Hydrocephalus
* Aphasia
* Serious psychiatric disorders
* MRI incompatibility and claustrophobia

Primary outcomes:
measure: Post-stroke epilepsy
timeFrame: 6 months
Secondary outcomes:
measure: Acute symptomatic seizure
timeFrame: 14 days
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs Hospital Stroke Unit
Study officials:
affiliation: Norwegian Science and Technology University
name: Axel Sandvig, PhD prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bentes C, Martins H, Peralta AR, Morgado C, Casimiro C, Franco AC, Fonseca AC, Geraldes R, Canhao P, Pinho E Melo T, Paiva T, Ferro JM. Early EEG predicts poststroke epilepsy. Epilepsia Open. 2018 Mar 7;3(2):203-212. doi: 10.1002/epi4.12103. eCollection 2018 Jun.
citation: Pitkanen A, Roivainen R, Lukasiuk K. Development of epilepsy after ischaemic stroke. Lancet Neurol. 2016 Feb;15(2):185-197. doi: 10.1016/S1474-4422(15)00248-3. Epub 2015 Nov 17.
citation: Wang G, Jia H, Chen C, Lang S, Liu X, Xia C, Sun Y, Zhang J. Analysis of risk factors for first seizure after stroke in Chinese patients. Biomed Res Int. 2013;2013:702871. doi: 10.1155/2013/702871. Epub 2013 Nov 2.
citation: Duss SB, Seiler A, Schmidt MH, Pace M, Adamantidis A, Muri RM, Bassetti CL. The role of sleep in recovery following ischemic stroke: A review of human and animal data. Neurobiol Sleep Circadian Rhythms. 2016 Nov 29;2:94-105. doi: 10.1016/j.nbscr.2016.11.003. eCollection 2017 Jan.
citation: Zollner JP, Schmitt FC, Rosenow F, Kohlhase K, Seiler A, Strzelczyk A, Stefan H. Seizures and epilepsy in patients with ischaemic stroke. Neurol Res Pract. 2021 Dec 6;3(1):63. doi: 10.1186/s42466-021-00161-w.
citation: Arntz RM, Rutten-Jacobs LC, Maaijwee NA, Schoonderwaldt HC, Dorresteijn LD, van Dijk EJ, de Leeuw FE. Poststroke Epilepsy Is Associated With a High Mortality After a Stroke at Young Age: Follow-Up of Transient Ischemic Attack and Stroke Patients and Unelucidated Risk Factor Evaluation Study. Stroke. 2015 Aug;46(8):2309-11. doi: 10.1161/STROKEAHA.115.010115. Epub 2015 Jul 2.
citation: Hassani M, Cooray G, Sveinsson O, Cooray C. Post-stroke epilepsy in an ischemic stroke cohort-Incidence and diagnosis. Acta Neurol Scand. 2020 Feb;141(2):141-147. doi: 10.1111/ane.13174. Epub 2019 Oct 22.
citation: Jungehulsing GJ, Heuschmann PU, Holtkamp M, Schwab S, Kolominsky-Rabas PL. Incidence and predictors of post-stroke epilepsy. Acta Neurol Scand. 2013 Jun;127(6):427-30. doi: 10.1111/ane.12070. Epub 2013 Feb 7.
citation: Zollner JP, Misselwitz B, Kaps M, Stein M, Konczalla J, Roth C, Krakow K, Steinmetz H, Rosenow F, Strzelczyk A. National Institutes of Health Stroke Scale (NIHSS) on admission predicts acute symptomatic seizure risk in ischemic stroke: a population-based study involving 135,117 cases. Sci Rep. 2020 Mar 2;10(1):3779. doi: 10.1038/s41598-020-60628-9.
citation: De Reuck J, Goethals M, Claeys I, Van Maele G, De Clerck M. EEG findings after a cerebral territorial infarct in patients who develop early- and late-onset seizures. Eur Neurol. 2006;55(4):209-13. doi: 10.1159/000093871. Epub 2006 Jun 13.