Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05487521 |
| Other study ID # |
M.D4312020 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
February 20, 2020 |
| Est. completion date |
May 10, 2022 |
Study information
| Verified date |
August 2022 |
| Source |
Ain Shams University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In general, the severity of the patients' language disorders fluctuated with the degree of
EEG epileptiform activity . Since then, a spectrum of disorders, often referred to
collectively as the epilepsy-aphasia spectrum, have been described that share features of
sleep potentiated EEG abnormalities, cognitive problems, and rare or even absent clinical
seizures .
In our study , Investigators evaluated the sleep EEG changes in pediatrics with languague
dysfunction then in patients with EEG changes , investigators gave treatment according to
type of EEG changes and investigators did a follow up assessment of language , EEG changes
and frequency of clinical seizures if present at first .
Description:
Language dysfunction is one of the most common problems in paediatrics. There is increased
interest in association of epilepsy and epileptiform EEG abnormalities to language
dysfunction.
Electrographic status epilepticus in sleep or continuous spike - wave in slow wave during
sleep, is a typical feature of acquired epileptic aphasia feature in sleep, or continuous
spike-wave in slow-wave sleep, is a typical.
Our study screened for sleep potentiated epileptiform discharges in children with language
dysfunction and effect of treatment of these epileptiform discharges on language dysfunction
improvement.
The aim of our work :
- The primary aim of this work was to screen for sleep potentiated epileptiform discharges
in children with language dysfunction.
- To evaluate effect of treatment of these epileptiform discharges on Language dysfunction
improvement .
Patients and methods :
- Type of Study: Observational longitudinal study.
- Study Period: From February 2020 till November 2021 .
- Study Population: Patients was recruited from the Pediatric Neurology Clinic, Pediatric
Outpatient Clinic, Phoniatrics Outpatient Clinic and the Inpatient Neurology ward at the
Ain Shams University Children hospital, Cairo, Egypt.
- Inclusion Criteria: The study was conducted on Children with :
- Language delay (their language age is below their chronological age ),or Language
regression (any convincing report of loss of previously acquired language skills,
whether or not prior language development was reported as normal or delayed)
(Meilleur et al., 2009)
- Age from 3 to 10 years old.
- Exclusion Criteria:
- Patients with hearing problems.
- Patients whose language delay can be explained by organic disease (e.g. post
Hypoxic ischemic encephalopathy, known inborn error of metabolism - whether this
language delay is isolated or occurring in the context of global developmental
delay).
- Patients with mental delay.
- Patients with autism spectrum disorder ( according to DSM-5 standardized criteria,
2013)
- Enviromentally deprived patients.
- Sampling Method: Consecutive random sampling .
- Sample Size: 93 patients with delayed or regressed language development. (Using PASS 11
program for sample size calculation and according to Nasr et al. (2001), the expected
frequency of children with epileptiform discharges =15-60%, assuming that frequency in
study population =40%±10%, sample size of 93 children can detect this frequency at 95%
confidence level).
- Ethical Considerations: A written informed consent was taken from the parents or legal
guardians before enrolment, after fully explaining to them the nature of the study.
The approval of the Research Ethics Committee at Ain Shams University was obtained ( M.D
4312020 ) .
- Study Procedures:
1. Full history taking:
- Detailed developmental history.
- Family history of same condition.
- History of seizures.
2. Clinical examination including:
- General examination.
- Full neurological examination.
- Vocal tract examination.
3. Clinical diagnostic aids :
- IQ assessment by rapid screening test of Stanford Binet 5th version (Hanoura,
2002).
- Assessment of language age by modified pre-school language screening test -
the Arabic version (Abou-Hassiba, 2011).
4. Investigations:
- MRI of the brain will be done. ((1.5 T) Phillips Achieva and Inginea )
- Auditory brainstem response (ABR). (GSI Audera will be used for acquiring ABR
waveforms).
- 90 minutes sleep EEG (one full sleep cycle) (using Nicolet REF 515-019000 rev
06, CareFusion, Middletown, WI 53562, USA) and placing electrodes by 10-20
placement system.
Patients whose EEG showed epileptogenic activity ,received treatment and a follow
up EEG and Assessment of language age by modified pre-school language screening
test - the Arabic version will be done after 6 months.
- Statistical Analysis: Numerical data will be summarized using mean and standard
deviations or medians and inter quartile ranges. Qualitative data will be presented as
count and percentage, p-value <0.005 will be considered significant.
- Statistical Package: Statistical analysis will be performed with statistical package for
social science (SPSS)version 23.0 (SPSS Inc., Chicago, Illinois, USA).
