Specific Language ImpairmentNCT04141332
Specific Language Impairment (SLI) in Children May Caused by Epileptic Brain Activity
An observational study of Specific Language Impairment, run by Mansoura University Hospital at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Specific Language Impairment
- What is being tested?
- EEG was recorded by EEG Machines
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2018to 1 Mar 2019
- Phase
- Observational
- 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 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study was conducted on 80 children with speech disorders in preschool children.
Who may be able to join
- 80 children were suffering from specific language impairment
- 80 healthy children with age and sex match control group.
Who cannot join
- Previous history of perinatal hypoxic-ischemic damage
- meningitis or encephalitis
- motor weakness
- hearing disorders
- IQ below seventy
- CP, social deprivation
- autism and
- psychiatric disorders .
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35516
About this study
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.
Read the 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.
- Conditions
- Specific Language Impairment
- Being tested
- EEG was recorded by EEG Machines
- Medical subject headings
- Specific Language Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG was recorded by EEG MachinesDiagnostic test
EEG was recorded by EEG Machines
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | 80 Patient Receives: Diagnostic Test: EEG was recorded by EEG Machines | |
| Group 2 | 80 Control subject Receives: Diagnostic Test: EEG was recorded by EEG Machines |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEGs finding
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".
Measured: 24-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start1 Feb 2018
- Primary completion1 Jan 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Specific Language ImpairmentStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Esmael, Mansoura University Hospital
- Investigators
- Esmael M Ahmed, MD, Principal investigator, Assistant Prof of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141332
- Sponsor's protocol ID
- Mansoura University Hospital
- Status last verified
- Oct 2019
- First submitted
- 23 Oct 2019
- Last updated
- 28 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tomas E, Vissers C. Behind the Scenes of Developmental Language Disorder: Time to Call Neuropsychology Back on Stage. Front Hum Neurosci. 2019 Jan 9;12:517. doi: 10.3389/fnhum.2018.00517. eCollection 2018.
PubMed 306870402-Kraft, S.J. & De Thorne, L.S. The Brave New World of Epigenetics: Embracing Complexity in the Study of Speech and Language Disorders Current Developmental Disorders Reports . 2014; 1: 207.
3-Hillert, Dieter. Encyclopedia of Evolutionary Psychological Science, Chapter: Neurobiology of Language, Publisher: Springer, Editors Viviana Weekes-Shackelford, Todd K. Shackelford, Viviana A. Weekes-Shackelford. Neurobiology of Language.2016: pp.1-15
Laasonen M, Smolander S, Lahti-Nuuttila P, Leminen M, Lajunen HR, Heinonen K, Pesonen AK, Bailey TM, Pothos EM, Kujala T, Leppanen PHT, Bartlett CW, Geneid A, Lauronen L, Service E, Kunnari S, Arkkila E. Understanding developmental language disorder - the Helsinki longitudinal SLI study (HelSLI): a study protocol. BMC Psychol. 2018 May 21;6(1):24. doi: 10.1186/s40359-018-0222-7.
PubMed 29784061Ghandour H, Eldin SK, Sallam Y, Mahmoud S. Associated comorbidities of specific language impairment. Benha Med J. 2018; 35:115-21.
Carol Westby. Social-Emotional Outcomes for Children With SLI . Word of Mouth. 2017 ; 28 (4):1-5.
Kim EH, Ko TS. Cognitive impairment in childhood onset epilepsy: up-to-date information about its causes. Korean J Pediatr. 2016 Apr;59(4):155-64. doi: 10.3345/kjp.2016.59.4.155. Epub 2016 Apr 30.
PubMed 27186225Syam UK, Thomas SV. Epileptiform activity in the electroencephalogram of 6-year-old children of women with epilepsy. Ann Indian Acad Neurol. 2016 Jul-Sep;19(3):318-22. doi: 10.4103/0972-2327.179974.
PubMed 27570381Holmes GL. What is more harmful, seizures or epileptic EEG abnormalities? Is there any clinical data? Epileptic Disord. 2014 Oct;16 Spec No 1(Spec No 1):S12-22. doi: 10.1684/epd.2014.0686.
PubMed 25323031Ung H, Cazares C, Nanivadekar A, Kini L, Wagenaar J, Becker D, Krieger A, Lucas T, Litt B, Davis KA. Interictal epileptiform activity outside the seizure onset zone impacts cognition. Brain. 2017 Aug 1;140(8):2157-2168. doi: 10.1093/brain/awx143.
PubMed 28666338McTague A, Howell KB, Cross JH, Kurian MA, Scheffer IE. The genetic landscape of the epileptic encephalopathies of infancy and childhood. Lancet Neurol. 2016 Mar;15(3):304-16. doi: 10.1016/S1474-4422(15)00250-1. Epub 2015 Nov 17.
PubMed 26597089Staley K. Molecular mechanisms of epilepsy. Nat Neurosci. 2015 Mar;18(3):367-72. doi: 10.1038/nn.3947. Epub 2015 Feb 24.
PubMed 25710839Faught E, Karakis I, Drane DL. The Impact of Interictal Discharges on Performance. Curr Neurol Neurosci Rep. 2018 Oct 8;18(12):88. doi: 10.1007/s11910-018-0892-9.
PubMed 30298240Luz-Escamilla L, Morales-Gonzalez JA. Association between Interictal Epileptiform Discharges and Autistic Spectrum Disorder. Brain Sci. 2019 Jul 30;9(8):185. doi: 10.3390/brainsci9080185.
PubMed 31366163Kane N, Acharya J, Benickzy S, Caboclo L, Finnigan S, Kaplan PW, Shibasaki H, Pressler R, van Putten MJAM. A revised glossary of terms most commonly used by clinical electroencephalographers and updated proposal for the report format of the EEG findings. Revision 2017. Clin Neurophysiol Pract. 2017 Aug 4;2:170-185. doi: 10.1016/j.cnp.2017.07.002. eCollection 2017. No abstract available.
PubMed 30214992
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specific Language Impairment (SLI) in Children May Caused by Epileptic Brain Activity
- ClinicalTrials.gov ID
- NCT04141332
- Acronym / sponsor ID
- Mansoura University Hospital
- Conditions
- Specific Language Impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Mansoura University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 28 Oct 2019 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: EEG was recorded by EEG Machines80 Patient |
| Group 2 | – | Diagnostic Test: EEG was recorded by EEG Machines80 Control subject |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study was conducted on 80 children with speech disorders in preschool children.
Key inclusion criteria (2 listed)
- 80 children were suffering from specific language impairment
- 80 healthy children with age and sex match control group.
Key exclusion criteria (8 listed)
- Previous history of perinatal hypoxic-ischemic damage
- meningitis or encephalitis
- motor weakness
- hearing disorders
- IQ below seventy
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 |
|---|---|---|
| EEG was recorded by EEG MachinesEEG was recorded by EEG Machines | Diagnostic test | Group 1, Group 2 |
Primary outcome
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".
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 28 Oct 2019.
- Results publication: PubMed 30687040Tomas E, Vissers C. Behind the Scenes of Developmental Language Disorder: Time to Call Neuropsychology Back on Stage. Front Hum Neurosci. 2019 Jan 9;12:517. doi: 10.3389/fnhum.2018.00517. eCollection 2018.
- Results publication2-Kraft, S.J. & De Thorne, L.S. The Brave New World of Epigenetics: Embracing Complexity in the Study of Speech and Language Disorders Current Developmental Disorders Reports . 2014; 1: 207.
- Results publication3-Hillert, Dieter. Encyclopedia of Evolutionary Psychological Science, Chapter: Neurobiology of Language, Publisher: Springer, Editors Viviana Weekes-Shackelford, Todd K. Shackelford, Viviana A. Weekes-Shackelford. Neurobiology of Language.2016: pp.1-15
- Results publication: PubMed 29784061Laasonen M, Smolander S, Lahti-Nuuttila P, Leminen M, Lajunen HR, Heinonen K, Pesonen AK, Bailey TM, Pothos EM, Kujala T, Leppanen PHT, Bartlett CW, Geneid A, Lauronen L, Service E, Kunnari S, Arkkila E. Understanding developmental language disorder - the Helsinki longitudinal SLI study (HelSLI): a study protocol. BMC Psychol. 2018 May 21;6(1):24. doi: 10.1186/s40359-018-0222-7.
- Results publicationGhandour H, Eldin SK, Sallam Y, Mahmoud S. Associated comorbidities of specific language impairment. Benha Med J. 2018; 35:115-21.
- Results publicationCarol Westby. Social-Emotional Outcomes for Children With SLI . Word of Mouth. 2017 ; 28 (4):1-5.
- Results publication: PubMed 27186225Kim EH, Ko TS. Cognitive impairment in childhood onset epilepsy: up-to-date information about its causes. Korean J Pediatr. 2016 Apr;59(4):155-64. doi: 10.3345/kjp.2016.59.4.155. Epub 2016 Apr 30.
- Results publication: PubMed 27570381Syam UK, Thomas SV. Epileptiform activity in the electroencephalogram of 6-year-old children of women with epilepsy. Ann Indian Acad Neurol. 2016 Jul-Sep;19(3):318-22. doi: 10.4103/0972-2327.179974.
- Results publication: PubMed 25323031Holmes GL. What is more harmful, seizures or epileptic EEG abnormalities? Is there any clinical data? Epileptic Disord. 2014 Oct;16 Spec No 1(Spec No 1):S12-22. doi: 10.1684/epd.2014.0686.
- Results publication: PubMed 28666338Ung H, Cazares C, Nanivadekar A, Kini L, Wagenaar J, Becker D, Krieger A, Lucas T, Litt B, Davis KA. Interictal epileptiform activity outside the seizure onset zone impacts cognition. Brain. 2017 Aug 1;140(8):2157-2168. doi: 10.1093/brain/awx143.
- Results publication: PubMed 26597089McTague A, Howell KB, Cross JH, Kurian MA, Scheffer IE. The genetic landscape of the epileptic encephalopathies of infancy and childhood. Lancet Neurol. 2016 Mar;15(3):304-16. doi: 10.1016/S1474-4422(15)00250-1. Epub 2015 Nov 17.
- Results publication: PubMed 25710839Staley K. Molecular mechanisms of epilepsy. Nat Neurosci. 2015 Mar;18(3):367-72. doi: 10.1038/nn.3947. Epub 2015 Feb 24.
- Individual participant dataSharing planned: No
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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.
Esmael M Ahmed, MD principal investigator
Assistant Prof of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Specific Language Impairment, run by Mansoura University Hospital 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 8 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 28 Oct 2019. 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.
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?
EEGs finding (time frame: 24-48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04141332, which also lists 30 linked publications.
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 28 Oct 2019.