INTERNATIONAL POST-STROKE EPILEPSY RESEARCH REPOSITORY
Mishra NK et al. BMJ Open 2023; 13:e078684.
Trial registration number: NCT06108102.
IPSERR's Mission
The International Post-Stroke Epilepsy Research Repository (IPSERR) will lodge data on PSE patients to support collaborative research. Using the data lodged within the IPSERR, we aim to standardize data collection, define common data elements and outcome measures for PSE research and develop criteria for standardized reporting of PSE research.
We recently reported a meta-analysis of 71 studies, including 20,110 patients with post-stroke seizures (PSS) and 11,66,085 patients without. We found that patients with PSS suffer from greater mortality risk, poor functional outcomes, greater disability, and increased dementia risk. We, however, observed disparate methods used by the individual investigators. We also noted variations in study reporting. We could not determine the response to antiseizure medications and the risk of drug resistance in PSS patients. We propose an individual patient data meta-analysis (IPD-MA) to tackle these limitations.
Our goal is to build IPSERR and conduct an IPD-MA using the data lodged within IPSERR.
Objectives
1. To determine epilepsy, functional, and cognitive outcomes in patients who develop post-stroke seizures.
2. To build and validate the PSE prediction models and compare performance against existing models.
Invitation to Authors
We invite the corresponding authors of all eligible studies and the IPSERC members to participate in IPSERR and share their IPD. We will provide co-authorship to each collaborator that shares their IPD.
Ethics and Governance
This study does not require separate ethics committee approval because the investigators of each contributed study have local ethical committee approval and written informed patient consent. We request only anonymized individual patient data from which the individuals recruited to the original study cannot be identified. We will consistently format the data to allow re-analysis. These data will be stored in password-protected files on REDCap, secured behind the university firewall. It will only be accessible by a member of the Data Management Committee. We will provide regular email updates to inform this international group of our activities. We will hold three monthly face-to-face zoom meetings to share progress and the results of the review.
Variable List for IPSERR
We ask the following data from study investigators:
IMPORTANT VARIABLES:
Patient MRN/ Unique Patient ID Imaging Variables Outcome Variables
Demographics 24. Brain imaging at seizure onset (Y/N) 45. Seizure at discharge
Age 25. If yes, type of brain imaging 46. Seizure at successive follow-ups
Gender 26. Anonymized imaging data sharable (Y/N) 47. Mortality at discharge
Race 27. Date of first CT scan after stroke 48. Mortality at successive follow-ups
Ethnicity 28. EEG at seizure onset (Y/N) 49. NIHSS at baseline
Clinical Variables 29. EEG data sharable (Y/N) 50. mRS score at discharge
Stroke subtypes Risk factors/ Predictors 51. mRS score at successive follow-ups
Stroke mechanism (TOAST) 30. Hypertension (Y/N) 52. Home time (length of hospital stay)
Date of first stroke 31. Diabetes Mellitus (Y/N) Biological samples
Recurrent stroke (Y/N) 32. Hyperlipidemia (Y/N) 53. Biological samples for sharing (Y/N)
Date of subsequent stroke 33. Myocardial Infarction (Y/N) 54. CSF sample obtained (Y/N)
Number of recurrent strokes 34. Atrial Fibrillation (Y/N) 55. Serum/plasma sample obtained (Y/N)
Presence of post-stroke seizure (Y/N) 35. Smoking (Y/N)
Definition of early and late seizures 36. Alcohol (Y/N)
Seizure subtypes 37. Other recreational drugs (Y/N)
Seizure classification by location 38. History of Stroke (Y/N)
Recurrent seizures (Y/N) 39. Malignancy (Y/N)
Number of recurrent seizures 40. History of Traumatic Brain Injury (Y/N)
Date of first seizure post-stroke 41. History of Prior Brain Injury (Y/N)
Hemorrhagic transformation (Y/N) Medications/ Treatment
Hematoma Volume 42. Antiseizure medications
Intraventricular Extension (Y/N) 43.Thrombolytic therapy
Midline shift (Y/N) 44. Endovascular Thrombectomy
Amount of midline shift (in mm)
OPTIONAL VARIABLES:
Clinical Variables Risk Factors Outcome Variables
Time of first stroke 10. Peripheral arterial disease (Y/N) 19. NIHSS at discharge
Time of subsequent stroke 11. Heart failure with reduced EF (Y/N) 20. NIHSS at successive follow-ups
Time to first seizure onset post-stroke 12. History of depression (Y/N) 21. Activity of Daily Living (ADL) score
ICH score 13. History of anxiety (Y/N) 22. MMSE score at discharge
Imaging Variables 14. History of insomnia (Y/N) 23. MMSE score at successive follow-ups
Time to first CT scan after stroke 15. History of cognitive impairment (Y/N) 24. Recurrent stroke at discharge
Date of first MRI after stroke 16. History of alcohol withdrawal seizures (Y/N) 25. Recurrent stroke at follow-ups
Time of first MRI after stroke 17. Time since neurobehavioral symptoms 26. Dementia at successive follow-ups
Date of EEG performed 18. Hydrocephalus (Y/N) 27. Depression at successive follow-ups
Time of EEG performed 28. Anxiety at successive follow-ups