Stroke Clinical Trial
— PRESTEPOfficial title:
Predisposing Factors for Post-stroke Epilepsy
NCT number | NCT05864547 |
Other study ID # | 527577 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 8, 2023 |
Est. completion date | December 2030 |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 2030 |
Est. primary completion date | December 2030 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Norway | St. Olavs Hospital Stroke Unit | Trondheim |
Lead Sponsor | Collaborator |
---|---|
Norwegian University of Science and Technology | St. Olavs Hospital |
Norway,
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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-stroke epilepsy | Minimum one documented case of post-stroke epilepsy after the stroke | 6 months | |
Secondary | Acute symptomatic seizure | Minimum one documented case of acute symptomatic seizure with epileptogenic activity recorded with EEG | 14 days |
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