Predisposing Factors for Post-stroke Epilepsy

Stroke Clinical Trial

— PRESTEP  

Official title:

Predisposing Factors for Post-stroke Epilepsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05864547
• Other study ID #: 527577
• Status: Recruiting
• Start date: May 8, 2023
• Est. completion date: December 2030

Study information

• Verified date: May 2023
• Source: Norwegian University of Science and Technology
• Contact: Axel Sandvig, PhD prof
• Phone: +47 47333042
• Email: axel.sandvig[@]ntnu.no
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Epilepsy
• Post Stroke Epilepsy
• Seizures
• Stroke

Locations

Country	Name	City	State
Norway	St. Olavs Hospital Stroke Unit	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (10)

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

Outcome

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