Specific Language Impairment (SLI) in Children May Caused by Epileptic Brain Activity

October 24, 2019 updated by: Ahmed Esmael, Mansoura University Hospital
The objective of this study was to find if there is a possible association and the impact of epilepsy and epileptiform activity in children with SLI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study concentrates on the impact of epileptiform activity for childhood epilepsy on the speech and language disturbances in addition to the associated social, cognitive and intellectual dysfunctions.

Study Type

Observational

Enrollment (Actual)

160

Contacts and Locations

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

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35516
        • Mansoura University Hospital

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

3 years to 6 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study was conducted on 80 children with speech disorders in preschool children.

Description

Inclusion Criteria:

  • 80 children were suffering from specific language impairment
  • 80 healthy children with age and sex match control group.

Exclusion Criteria:

  • Previous history of perinatal hypoxic-ischemic damage
  • meningitis or encephalitis
  • motor weakness
  • hearing disorders
  • IQ below seventy
  • CP, social deprivation
  • autism and
  • psychiatric disorders .

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
Intervention / Treatment
Group 1
80 Patient
Diagnostic test: EEG was recorded by EEG Machines
EEG was recorded by EEG Machines
Group 2
80 Control subject
Diagnostic test: EEG was recorded by EEG Machines
EEG was recorded by EEG Machines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EEGs finding
Time Frame: 24-48 hours

EEGs finding were defined according to the followings "Normal: within the range of frequency and amplitude distribution." "Epileptiform: Describes transient background activity with a characteristic spikes, sharp waves, spike-slow wave or sharp-slow wave complexes of focal or generalized distribution".

"Abnormal non-epileptiform: deviations from normal in terms of background frequency patterns, usually in the form of excessive slow activity".
24-48 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intelligence quotient (IQ)
Time Frame: 24-72 hours

An intelligence quotient (IQ) is a total score derived from several standardized tests designed to assess human intelligence. Historically, IQ is a score obtained by dividing a person's mental age score, obtained by administering an intelligence test, by the person's chronological age, both expressed in terms of years and months. The resulting fraction is multiplied by 100 to obtain the IQ score.

When current IQ tests were developed, the median raw score of the norming sample is defined as IQ 100 and scores each standard deviation (SD) up or down are defined as 15 IQ points greater or less.
24-72 hours
social age
Time Frame: 24-48 hours
Evaluation of social age: using the Vineland Social Maturity Scale . VSMS was used along with a cognitive assessment to help make a diagnosis of mental retardation or intellectual disability. It has also been used extensively to assess the development of activities of everyday life.
24-48 hours
cognitive age
Time Frame: 24-48 hours
Evaluation of cognitive age (mental age): using the Stanford Binet Intelligence Scale. The Stanford-Binet test is a examination meant to gauge intelligence through five factors of cognitive ability. These five factors include fluid reasoning, knowledge, quantitative reasoning, visual-spatial processing and working memory. Both verbal and nonverbal responses are measured.
24-48 hours
language assessment
Time Frame: 24-72 hours
Language evaluation: by Comprehensive Arabic Language Test (CALT). The CALT was constructed by the members of the Department of Phoniatrics at Alexandria Main University Hospital, Egypt, to form a detailed comprehensive assessment battery for Arabic language and test its reliability and validity to use it in the early detection of subtle changes in the various components of language in cases of language impaired children.
24-72 hours

Collaborators and Investigators

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

Sponsor

Mansoura University Hospital

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)

February 1, 2018

Primary Completion (ACTUAL)

January 1, 2019

Study Completion (ACTUAL)

March 1, 2019

Study Registration Dates

First Submitted

October 23, 2019

First Submitted That Met QC Criteria

October 24, 2019

First Posted (ACTUAL)

October 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 28, 2019

Last Update Submitted That Met QC Criteria

October 24, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mansoura University Hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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