Post Stroke EpilepsyPRESTEPNCT05864547
Predisposing Factors for Post-stroke Epilepsy
An observational study of Post Stroke Epilepsy and Stroke, run by Norwegian University of Science and Technology at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Stroke Epilepsy, Stroke, Epilepsy
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- 8 May 2023to Dec 2030
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Previous stroke or brain surgery
- Traumatic brain injuries
- Neurodegenerative diseases
- Brain tumors
- Epilepsy before the stroke
- Hydrocephalus
Show all 9Show fewer
- Aphasia
- Serious psychiatric disorders
- MRI incompatibility and claustrophobia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
St. Olavs Hospital Stroke Unit
Trondheim
Hanne Ellekjær, PhD, +47 72575494, Hanne.Ellekjer@stolav.no
About this study
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.
Read the 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.
- Conditions
- Post Stroke Epilepsy, Stroke, Epilepsy, Seizures
- Keywords
- Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Disorders, Vascular Diseases
- Medical subject headings
- Stroke, Epilepsy, Seizures, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-stroke epilepsy
Minimum one documented case of post-stroke epilepsy after the stroke
Measured: 6 months
Secondary outcomes (1)
Acute symptomatic seizure
Minimum one documented case of acute symptomatic seizure with epileptogenic activity recorded with EEG
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start8 May 2023
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Post Stroke EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Axel Sandvig, PhD prof, Principal investigator, Norwegian Science and Technology University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864547
- Sponsor's protocol ID
- 527577
- Acronym
- PRESTEP
- Status last verified
- Jul 2026
- First submitted
- 9 May 2023
- Last updated
- 7 Jul 2026
- Results posted
- No
- Individual data sharing
- No
Publications
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.
PubMed 29881799Pitkanen 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.
PubMed 26597090Wang 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.
PubMed 24298553Duss 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.
PubMed 31236498Zollner 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.
PubMed 34865660Arntz 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.
PubMed 26138118Hassani 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.
PubMed 31580473Jungehulsing 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.
PubMed 23398544Zollner 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.
PubMed 32123219De 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.
PubMed 16772712
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predisposing Factors for Post-stroke Epilepsy
- ClinicalTrials.gov ID
- NCT05864547
- Acronym / sponsor ID
- PRESTEP / 527577
- Conditions
- Post Stroke Epilepsy, Stroke, Epilepsy, Seizures
- Keywords
- Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Disorders, Vascular Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- 8 May 2023 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- Previous stroke or brain surgery
- Traumatic brain injuries
- Neurodegenerative diseases
- Brain tumors
- Epilepsy before the stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post-stroke epilepsy
Time frame: 6 months
Minimum one documented case of post-stroke epilepsy after the stroke
1 secondary outcome
Acute symptomatic seizure
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 29881799Bentes 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.
- Background: PubMed 26597090Pitkanen 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.
- Background: PubMed 24298553Wang 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.
- Background: PubMed 31236498Duss 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.
- Background: PubMed 34865660Zollner 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.
- Background: PubMed 26138118Arntz 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.
- Background: PubMed 31580473Hassani 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.
- Background: PubMed 23398544Jungehulsing 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.
- Background: PubMed 32123219Zollner 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.
- Background: PubMed 16772712De 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Axel Sandvig, PhD prof principal investigator
Norwegian Science and Technology University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Stroke Epilepsy and Stroke, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Axel Sandvig, PhD prof (+47 47333042, axel.sandvig@ntnu.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-stroke epilepsy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05864547, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.