PRESTEP: Predisposing Factors for Post-stroke Epilepsy

Sponsor
Norwegian University of Science and Technology (Other)
Overall Status
Recruiting
CT.gov ID
NCT05864547
Collaborator
St. Olavs Hospital (Other)
30
1
90.8
0.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Predisposing Factors for Post-stroke Epilepsy
    Actual Study Start Date :
    May 8, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2030
    Anticipated Study Completion Date :
    Dec 1, 2030

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Post-stroke epilepsy [6 months]

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

    Secondary Outcome Measures

    1. Acute symptomatic seizure [14 days]

      Minimum one documented case of acute symptomatic seizure with epileptogenic activity recorded with EEG

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Olavs Hospital Stroke Unit Trondheim Norway

    Sponsors and Collaborators

    • Norwegian University of Science and Technology
    • St. Olavs Hospital

    Investigators

    • Principal Investigator: Axel Sandvig, PhD prof, Norwegian Science and Technology University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Norwegian University of Science and Technology
    ClinicalTrials.gov Identifier:
    NCT05864547
    Other Study ID Numbers:
    • 527577
    First Posted:
    May 18, 2023
    Last Update Posted:
    May 22, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Norwegian University of Science and Technology
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 22, 2023