Predisposing Factors for Post-stroke Epilepsy (PRESTEP)

June 5, 2025 updated by: Norwegian University of Science and Technology

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Norway
      • Trondheim, Norway
        • Recruiting
        • St. Olavs Hospital Stroke Unit
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-stroke epilepsy
Time Frame: 6 months
Minimum one documented case of post-stroke epilepsy after the stroke
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute symptomatic seizure
Time Frame: 14 days
Minimum one documented case of acute symptomatic seizure with epileptogenic activity recorded with EEG
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2023

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

May 9, 2023

First Submitted That Met QC Criteria

May 9, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

June 10, 2025

Last Update Submitted That Met QC Criteria

June 5, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 527577

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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