NCT07135713

Brief Summary

Identify and characterize electrocardiographic (ECG) changes occurring during the post-ictal phase of epileptic seizures. Evaluate the duration and severity of post-ictal ECG abnormalities. Assess the correlation between ECG changes and seizure type, duration, and severity. Explore the association of ECG changes with patient demographics

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Oct 2025

Shorter than P25 for all trials

Status
not yet 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 Progress60%
Oct 2025Oct 2026

First Submitted

Initial submission to the registry

July 18, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 22, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

11 months

First QC Date

July 18, 2025

Last Update Submit

August 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Out come measure

    Title: Prevalence of Post-Ictal Electrocardiographic (ECG) Abnormalities Description: The proportion of participants who experience post-ictal ECG abnormalities, including sinus tachycardia, bradycardia, QT/QTc interval changes, ST-T segment changes, atrial/ventricular ectopy, or conduction blocks. Assessment will be performed using a standard 12-lead electrocardiogram (ECG). Unit of Measure: Percentage of participants

    Baseline (immediate post-ictal phase)

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Eighty (80) children with epilepsy will be included in this study during the period from October 2025 to October 2026. Sample size was calculated by Open Epi Info version 3

You may qualify if:

  • Children from 1 year to 18 year are diagnosed with epilepsy.
  • Routine EEG.

You may not qualify if:

  • Known pre-existing cardiac conditions e.g arrhythmias, heart failure.
  • Current use of medications significantly affecting ECG.
  • Other causes of convulsion:hypoglycemia,hypernatriemia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Katyayan A, Diaz-Medina G. Epilepsy: Epileptic Syndromes and Treatment. Neurol Clin. 2021 Aug;39(3):779-795. doi: 10.1016/j.ncl.2021.04.002.

    PMID: 34215386BACKGROUND
  • Ibrahim A, Megahed A, Salem A, Zekry O. Impact of Cardiac Injury on the Clinical Outcome of Children with Convulsive Status Epilepticus. Children (Basel). 2022 Jan 18;9(2):122. doi: 10.3390/children9020122.

    PMID: 35204843BACKGROUND
  • Bastos F, Cross JH. Epilepsy. Handb Clin Neurol. 2020;174:137-158. doi: 10.1016/B978-0-444-64148-9.00011-9.

    PMID: 32977874BACKGROUND

Central Study Contacts

Samaan Rezk Gad El kariem, Master

CONTACT

Eman Fathallah Gad, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor, Department of Pediatrics, Assiut University Children's Hospital

Study Record Dates

First Submitted

July 18, 2025

First Posted

August 22, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

August 22, 2025

Record last verified: 2025-08