NCT06194422

Brief Summary

Epilepsy is defined as a chronic disorder that presents with recurrent episodes of unprovoked seizures. Epileptic seizures are caused by excessive excitation of cortical neurons. The condition has various etiologies and comorbidities. Classification; The Classification of Epilepsies includes several diagnostic levels (steps):

  1. 1.from seizure type to epilepsy type (generalized/focal/combined generalized and focal/unknown)
  2. 2.etiology (genetic/ structural/ infectious/ metabolic/ immune/unknown). A clinician can use any level of the classification

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

December 30, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 8, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2025

Completed
Last Updated

January 8, 2024

Status Verified

January 1, 2024

Enrollment Period

1 year

First QC Date

November 20, 2023

Last Update Submit

January 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Psychiatric comorbidities in children with generalized epilepsy

    Measuring the prevalence of ADHD and Autism among children suffering from generalized epilepsy .All cases included in the study will be evaluated by: * full history including neurological history . * full examination including neurological examination . * Investigations: * EEG * ADHD Symptom Checklist-4 (ADHD-SC4( \[8\] * Gilliam Autism Rating scale ( GARS) \[9\] Sample size calculation: Based on determining the main outcome variable, the estimated minimum required total sample size is 62 participants . Main outcome variable: to evaluate phsycatric complications among epilitic pediatric patients. based on previous study, (40%) and (11-30%) ADHD and Autisim In epilitic children respectively . \[10-11\] Main statistical test is chi square to detect the difference in percentage of physiatric disorders( ADHD and Autism) in the two groups . Alpha error = 0.05 Power = 0.80 Allocation ratio= 1 One tailed.

    baseline

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

psychiatric comorbidities in children with generalized epilepsy

You may qualify if:

  • Patients with generalized epilepsy either new or old ,controlled or un controlled .
  • School aged patients (from 6 years to 17 years).
  • Patients on anti epileptic treatment .
  • Patients attending children's neurological unit .

You may not qualify if:

  • \- children with other types of epilepsy .
  • children with cerebral palsy.
  • children with neurodegenerative disease.
  • children with neurometabolic disease.
  • mentally retarded children.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor

Study Record Dates

First Submitted

November 20, 2023

First Posted

January 8, 2024

Study Start

December 30, 2023

Primary Completion

December 31, 2024

Study Completion

March 24, 2025

Last Updated

January 8, 2024

Record last verified: 2024-01