Language Disorders in ChildrenPhase 3NCT05487521
EEG Changes in Pediatrics With Language Dysfunction Evaluation of Sleep EEG Changes in Paediatric Patients With Language Dysfunction: A Follow up Study. EEG Changes in Pediatrics With Language Dysfunction
A Phase 3 study testing Methylprednisolone and or prednisolone in people with Language Disorders in Children, run by Ain Shams University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Language Disorders in Children
- What is being tested?
- Methylprednisolone and or prednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2020to 10 May 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- o 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.
Who cannot join
- o 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Sleep EEG Changes in Paediatric Patients With Language Dysfunction: A Follow up Study. Evaluation of Sleep EEG Changes in Paediatric Patients With Language Dysfunction: A Follow up Study. Evaluation of Sleep EEG Changes in Pediatric Patients With Language Dysfunction : A Follow up Study
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 .
Read the detailed 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:
- Full history taking:
- Detailed developmental history.
- Family history of same condition.
- History of seizures.
- Clinical examination including:
- General examination.
- Full neurological examination.
- Vocal tract examination.
- 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).
- 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).
- Conditions
- Language Disorders in Children
- Being tested
- Methylprednisolone and or prednisolone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone and or prednisoloneDrug
we gave methylprednisolone and or prednisolone to patients with EEG activity and follow up the effect of the drug on language
| Study group | Role | What they receive |
|---|---|---|
| Patients without EEG changes or clinical seizures | No intervention | Not described |
| Patients with EEG changes or clinical seizures | Experimental | Not described Receives: Drug: Methylprednisolone and or prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
language age of the patient
we follow up language age of the patient after treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start20 Feb 2020
- Primary completion10 Nov 2021
- Study completion10 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Language Disorders in ChildrenStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia Alaa Mahsoub Abdelsalam, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487521
- Sponsor's protocol ID
- M.D4312020
- Status last verified
- Aug 2022
- First submitted
- 1 Aug 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sleep EEG Changes in Paediatric Patients With Language Dysfunction: A Follow up Study. Evaluation of Sleep EEG Changes in Paediatric Patients With Language Dysfunction: A Follow up Study. Evaluation of Sleep EEG Changes in Pediatric Patients With Language Dysfunction : A Follow up Study
- ClinicalTrials.gov ID
- NCT05487521
- Acronym / sponsor ID
- M.D4312020
- Conditions
- Language Disorders in Children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 10 Nov 2021 (actual)
- Study completion
- 10 May 2022 (actual)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Detailed 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:
- Full history taking:
- Detailed developmental history.
- Family history of same condition.
- History of seizures.
- Clinical examination including:
- General examination.
- Full neurological examination.
- Vocal tract examination.
- 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).
- 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).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients without EEG changes or clinical seizures | No intervention | – |
| Patients with EEG changes or clinical seizures | Experimental | Drug: Methylprednisolone and or prednisolone |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- o 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)
Key exclusion criteria (5 listed)
- o Patients with hearing problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylprednisolone and or prednisolonewe gave methylprednisolone and or prednisolone to patients with EEG activity and follow up the effect of the drug on language | Drug | Patients with EEG changes or clinical seizures |
Primary outcome
language age of the patient
Time frame: 6 months
we follow up language age of the patient after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methylprednisolone and or prednisolone in people with Language Disorders in Children, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
language age of the patient (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.