NCT06922734

Brief Summary

This research aims to determine the frequency of seizures in patients following a stroke, identify risk factors associated with post-stroke seizures, and characterize EEG changes linked to these seizures. Unexplored alterations in the aperiodic component of the EEG in post-stroke patients could potentially serve as novel biological markers for epilepsy after stroke.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
602

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Nov 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Nov 2014Dec 2026

Study Start

First participant enrolled

November 1, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2015

Completed
9.4 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 10, 2025

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

12 months

First QC Date

April 3, 2025

Last Update Submit

February 3, 2026

Conditions

StrokeSeizuresEEG Power SpectraSerum BiomarkersCT ScanMR Biomarkers

Keywords

strokeseizuresepilepsyeegaperiodic componentserum biomarkersCT scanMRI

Outcome Measures

Primary Outcomes (3)

  • Post-stroke seizure prevalence

    From enrollment of first patient to the last one in 12 months

  • Risk factors of post-stroke seizures

    Investigators are interested in serum and radiological biomarkers as risk factors for post-stroke seizures

    From enrollment of first patient to the last one in 12 months

  • post-stroke EEG characteristics

    Investigators are interested in specific EEG changes which may indicate risk factors for post-stroke seizures

    From enrollment of first patient to the last one in 12 months

Secondary Outcomes (1)

  • Aperiodic EEG component in patients after stroke with and without seizures

    From enrollment to the end of hospitalisation

Study Arms (4)

EEG+/EPI+ group

Patients with epileptiform EEG changes and seizures

EEG+/EPI- group

Patients with epileptiform EEG changes but no seizures

EEG-/EPI-group

Patients without epileptiform EEG changes and no seizures

KON group

A control group of comparable healthy individuals

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study included 602 patients with acute stroke or post-stroke seizures who were admitted to the Neurology Division at the University Medical Centre Maribor over a 12-month period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UKC Maribor

Maribor, 2000, Slovenia

Location

Related Publications (5)

  • Bentes C, Rodrigues FB, Sousa D, Duarte GS, Franco AC, Marques R, Nzwalo H, Peralta AR, Ferro JM, Costa J. Frequency of post-stroke electroencephalographic epileptiform activity - a systematic review and meta-analysis of observational studies. Eur Stroke J. 2017 Dec;2(4):361-368. doi: 10.1177/2396987317731004. Epub 2017 Sep 13.

    PMID: 31008328BACKGROUND

  • Tatillo C, Legros B, Depondt C, Rikir E, Naeije G, Jodaitis L, Ligot N, Gaspard N. Prognostic value of early electrographic biomarkers of epileptogenesis in high-risk ischaemic stroke patients. Eur J Neurol. 2024 Jan;31(1):e16074. doi: 10.1111/ene.16074. Epub 2023 Sep 27.

    PMID: 37754551BACKGROUND

  • Tanaka T, Ihara M, Fukuma K, Mishra NK, Koepp MJ, Guekht A, Ikeda A. Pathophysiology, Diagnosis, Prognosis, and Prevention of Poststroke Epilepsy: Clinical and Research Implications. Neurology. 2024 Jun 11;102(11):e209450. doi: 10.1212/WNL.0000000000209450. Epub 2024 May 17.

    PMID: 38759128BACKGROUND

  • Pani SM, Saba L, Fraschini M. Clinical applications of EEG power spectra aperiodic component analysis: A mini-review. Clin Neurophysiol. 2022 Nov;143:1-13. doi: 10.1016/j.clinph.2022.08.010. Epub 2022 Aug 28.

    PMID: 36088797BACKGROUND

  • Fukuma K, Tojima M, Tanaka T, Kobayashi K, Kajikawa S, Shimotake A, Kamogawa N, Ikeda S, Ishiyama H, Abe S, Morita Y, Nakaoku Y, Ogata S, Nishimura K, Koga M, Toyoda K, Matsumoto R, Takahashi R, Ikeda A, Ihara M. Periodic discharges plus fast activity on electroencephalogram predict worse outcomes in poststroke epilepsy. Epilepsia. 2023 Dec;64(12):3279-3293. doi: 10.1111/epi.17760. Epub 2023 Oct 30.

    PMID: 37611936BACKGROUND

Related Links

MeSH Terms

Conditions

StrokeSeizuresEpilepsy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Martin Rakusa, Asoc. Prof.

    UKC Maribor

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Senior Consultant Neurologist

Study Record Dates

First Submitted

April 3, 2025

First Posted

April 10, 2025

Study Start

November 1, 2014

Primary Completion

October 31, 2015

Study Completion (Estimated)

December 31, 2026

Last Updated

February 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Due to national laws we can't share data from this study.

Locations

SL(1)