Predisposing Factors for Post-stroke Epilepsy

NCT05864547 | Recruiting

• 1 other identifier: 527577
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Stroke Epilepsy; Stroke; Epilepsy; Seizures

Keywords

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Disorders; Vascular Diseases

Outcome Measures

Primary Outcomes (1)

• Post-stroke epilepsy

  Minimum one documented case of post-stroke epilepsy after the stroke

  6 months

Secondary Outcomes (1)

• Acute symptomatic seizure

  14 days

Study Arms (2)

Stroke patients

Patients with first time stroke admitted to the stroke unit, St. Olavs hospital, Trondheim, Norway. The planned cohort size is 15-20 patients.

Healthy controls

Age and gender matched healthy volunteers without previous stroke. The same number of healthy controls as recruited patients will be recruited through ads in the local newspaper.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

St. Olavs Hospital Stroke Unit

Trondheim, Norway

RECRUITING

Related Publications (10)

• 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.

  PMID: 29881799 BACKGROUND

• 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.

  PMID: 26597090 BACKGROUND

• 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.

  PMID: 24298553 BACKGROUND

• 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.

  PMID: 31236498 BACKGROUND

• 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.

  PMID: 34865660 BACKGROUND

• 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.

  PMID: 26138118 BACKGROUND

• 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.

  PMID: 31580473 BACKGROUND

• 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.

  PMID: 23398544 BACKGROUND

• 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.

  PMID: 32123219 BACKGROUND

• 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.

  PMID: 16772712 BACKGROUND

MeSH Terms

Conditions

Stroke; Epilepsy; Seizures; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Axel Sandvig, PhD prof

  Norwegian Science and Technology University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Axel Sandvig, PhD prof

CONTACT

+47 47333042; axel.sandvig@ntnu.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 18, 2023
• Study Start: May 8, 2023
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)