International Post-Stroke Epilepsy Research Repository

NCT06108102 | Enrolling By Invitation

• 2 other identifiers: 2000032731No NIH funding
• Study Type: observational
• Target: 8,000
• Locations: 1 country
• Sites: 1

Brief Summary

The International Post-Stroke Epilepsy Research Repository (IPSERR): The study aims to collate and categorize data reported by post-stroke epilepsy (PSE) researchers and lodge it within the IPSERR. Using the IPSERR database, we will conduct two individual patient data (IPD) analyses: (1) determine epilepsy, functional, and cognitive outcomes in stroke patients who develop post-stroke seizure and (2) build and validate post-stroke epilepsy prediction model and compare performance against existing models.

Conditions

Post Stroke Epilepsy; Post Stroke Seizure; Stroke; Epilepsy

Keywords

Post-stroke epilepsy; Clinical outcomes; Prognosis; Individual patient data

Outcome Measures

Primary Outcomes (7)

• Mortality (modified Rankin Scale = 6)

  The modified Rankin Scale (mRS) is a clinician-reported measure of global disability for evaluating recovery from stroke. It ranges from 0 (no symptoms) to 6 (death).

  At 1 year, 2 year, and 5 year follow-up

• Poor functional outcome (modified Rankin Scale 3-6)

  The modified Rankin Scale (mRS) is a clinician-reported measure of global disability for evaluating recovery from stroke. It ranges from 0 (no symptoms) to 6 (death), with 0-2 indicating a good functional outcome and 3-6 indicating a poor functional outcome.

  At 1 year, 2 year, and 5 year follow-up

• Seizure frequency

  Number of seizures post-stroke identified clinically or based on an electroencephalogram (EEG).

  At 1 year, 2 year, and 5 year follow-up

• Seizure severity

  Defined by impaired awareness and the presence of bilateral tonic or clonic seizures.

  At 1 year, 2 year, and 5 year follow-up

• Occurrence or frequency of status epilepticus

  Status epilepticus is defined as a seizure or series of seizures lasting more than 30 minutes without recovery of consciousness based on electroencephalogram (EEG) findings.

  At 1 year, 2 year, and 5 year follow-up

• Length of hospital stay

  The duration of hospital admission for a stroke is measured in days.

  At 1 year, 2 year, and 5 year follow-up

• Cognitive decline assessed on an 11-question Mini-Mental State Examination (MMSE) tool or a 30-point Montreal Cognitive Assessment (MoCA) scale

  MMSE is tests cognitive function. It is scored out of 30, with a score of ≤26 indicating cognitive impairment. MoCA assesses mild cognitive dysfunction. It is scored out of 30, with a score of ≤24 indicating cognitive impairment.

  At 1 year, 2 year, and 5 year follow-up

Secondary Outcomes (5)

• Recurrent stroke

  At 1 year, 2 year, and 5 year follow-up

• Antiseizure medication discontinuation

  At 1 year, 2 year, and 5 year follow-up

• Treatment adverse events

  At 1 year, 2 year, and 5 year follow-up

• Depression assessed on 21-item Hamilton Depression Rating Scale (HAM-D)

  At 1 year, 2 year, and 5 year follow-up

• Anxiety assessed on 14-item Hamilton Anxiety Rating Scale (HAM-A)

  At 1 year, 2 year, and 5 year follow-up

Study Arms (2)

Post-stroke epilepsy

Stroke patients aged ≥18 years, with ischemic or hemorrhagic stroke, presenting with early or late onset post-stroke seizures.

Other: Presence of stroke, either ischemic or hemorrhagic (intracerebral and subarachnoid)

No post-stroke epilepsy

Stroke patients aged ≥18 years, with ischemic or hemorrhagic stroke, presenting with no post-stroke seizures.

Other: Presence of stroke, either ischemic or hemorrhagic (intracerebral and subarachnoid)

Interventions

Presence of stroke, either ischemic or hemorrhagic (intracerebral and subarachnoid) OTHER

Presence of ischemic or hemorrhagic stroke confirmed by neuroimaging and clinical diagnosis

No post-stroke epilepsy; Post-stroke epilepsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with stroke aged ≥18 years, with ischemic or hemorrhagic stroke, presenting with early or late post-stroke seizures. Patients presenting ≤1 week will be classified as early seizures and \>1 week will be classified as late seizures.

You may qualify if:

• Studies with minimum dataset of 100 patients
• Studies comprising stroke patients aged ≥18 years, with ischemic or hemorrhagic stroke, presenting early or late PSS with data on patient outcome measures.
• Documented consent or waiver of consent following local Institutional Review Board-approved procedure.
• Studies published on human subjects.
• No restriction based on the date or language of publication, gender, or ethnicity.

You may not qualify if:

• Studies of patients with a prior history of seizures before the index stroke,
• Studies that did not report outcome data, or are not able to share IPD.

Sponsors & Collaborators

• Yale University: lead
• Monash University: collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

• Mishra NK, Kwan P, Tanaka T, Sunnerhagen KS, Dawson J, Zhao Y, Misra S, Wang S, Sharma VK, Mazumder R, Funaro MC, Ihara M, Nicolo JP, Liebeskind DS, Yasuda CL, Cendes F, Quinn TJ, Ge Z, Scalzo F, Zelano J, Kasner SE; International Post-Stroke Epilepsy Research Consortium (IPSERC); International Post Stroke Epilepsy Research Consortium (IPSERC). Clinical characteristics and outcomes of patients with post-stroke epilepsy: protocol for an individual patient data meta-analysis from the International Post-stroke Epilepsy Research Repository (IPSERR). BMJ Open. 2023 Nov 15;13(11):e078684. doi: 10.1136/bmjopen-2023-078684.

  PMID: 37968000 BACKGROUND

MeSH Terms

Conditions

Stroke; Epilepsy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nishant K Mishra, MD PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: March 1, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: October 29, 2025

Record last verified: 2025-10

Locations

US (1)