Epilepsy SyndromeNCT05097742
Cognitive Impairments in Children With Epilepsy
An observational study of Epilepsy Syndrome, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Since the proportion of language and attentional difficulties in patients with epilepsy is recognized, both in the literature and in the clinical experience of practitioners, it is appropriate to propose a complete speech-language assessment of oral language and attention.This study investigates these impairments… Read more about this study
- Who is it for?
- Ages 3 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy Syndrome
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2021to 20 Feb 2022
- 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 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with epilepsy followed by Dr COLMARD at the Montpellier hospital and university center
Who may be able to join
- The subjects should :
- Be at least 3 years old and at most 15 years old
- Be French speaker
- Be in a regular class
- Have a diagnosis of epilepsy
Who cannot join
- Subjects schooled in IEM
- Subjects diagnosed with austim spectrum disorder
- Subjects with a motor or visual handicap
- Subjects with psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of Speech Therapy in Children With Epilepsy: What Impairments of Cognitive Functions?
Since the proportion of language and attentional difficulties in patients with epilepsy is recognized, both in the literature and in the clinical experience of practitioners, it is appropriate to propose a complete speech-language assessment of oral language and attention.This study investigates these impairments through the taking of specific tests.
The general objective of this study is to observe possible oral language and attention disorders in children with epilepsy, by age and etiology of epilepsy.
The objective of this work is to study therapeutic apheresis (including plasma exchange and immunoadsorption) among french neuropediatric tertiary centers and to prove that this treatment modality is effective and well tolerated in pediatric neurology diseases.
- Conditions
- Epilepsy Syndrome
- Keywords
- Speech therapy, Neurology, Children, Oral language, Attention, Type of epilepsy (focal epilepsy or generalized epilepsy), Etiology of epilepsy (unknown, idiopathic, structural, metabolic, immune, infectious), Epilepsy syndrome
- Medical subject headings
- Epileptic Syndromes, Communication Disorders, Epilepsies, Partial, Epilepsy, Generalized, Communicable Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Score in the different tests assessing oral language
Test assessing oral language :
- Oral naming of images
- Oral designation of images
- Morphosyntactic comprehension test
- Syntactic production test
The scores obtained in the various tests are organized into 7 classes:
Class 1 = percentiles less than 7 : "pathological" zone Class 2 = 7 to 20 percentiles : "fragile" zone / "weak" zone Class 3 = 21 to 38 percentiles : "low standard" zone Class 4 = percentiles 39 to 62 : "median standard" zone / expected average results for age or grade level Class 5 = 63 to 80 percentiles : "higher standard" zone Classes 6 and 7 = respectively 81 to 93 percentiles and percentiles greater than 93 : zone with results well above the norm for age or grade level.
Measured: day 1
Secondary outcomes (1)
Score in the different tests assessing attention
Tests assessing attention :
- Visual attention test
- Auditive attention test
The scores obtained in the various tests are organized into 7 classes:
Class 1 = percentiles less than 7 : "pathological" zone Class 2 = 7 to 20 percentiles : "fragile" zone / "weak" zone Class 3 = 21 to 38 percentiles : "low standard" zone Class 4 = percentiles 39 to 62 : "median standard" zone / expected average results for age or grade level Class 5 = 63 to 80 percentiles : "higher standard" zone Classes 6 and 7 = respectively 81 to 93 percentiles and percentiles greater than 93 : zone with results well above the norm for age or grade level.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start15 Oct 2021
- Primary completion1 Feb 2022
- Study completion20 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxime colmard, résident, Principal investigator, UH MONTPELLIERMoritz-Gasser Sylvie, Study chair, UH MONTPELLIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097742
- Sponsor's protocol ID
- RECHMPL21_0638
- Status last verified
- Apr 2022
- First submitted
- 27 Oct 2021
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Speech Therapy in Children With Epilepsy: What Impairments of Cognitive Functions?
- ClinicalTrials.gov ID
- NCT05097742
- Acronym / sponsor ID
- RECHMPL21_0638
- Conditions
- Epilepsy Syndrome
- Keywords
- Speech therapy, Neurology, Children, Oral language, Attention, Type of epilepsy (focal epilepsy or generalized epilepsy), Etiology of epilepsy (unknown, idiopathic, structural, metabolic, immune, infectious), Epilepsy syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 20 Feb 2022 (actual)
- First posted
- 28 Oct 2021 (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.
Since the proportion of language and attentional difficulties in patients with epilepsy is recognized, both in the literature and in the clinical experience of practitioners, it is appropriate to propose a complete speech-language assessment of oral language and attention.This study investigates these impairments through the taking of specific tests.
The general objective of this study is to observe possible oral language and attention disorders in children with epilepsy, by age and etiology of epilepsy.
The objective of this work is to study therapeutic apheresis (including plasma exchange and immunoadsorption) among french neuropediatric tertiary centers and to prove that this treatment modality is effective and well tolerated in pediatric neurology diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with epilepsy followed by Dr COLMARD at the Montpellier hospital and university center
Key inclusion criteria (5 listed)
- Be at least 3 years old and at most 15 years old
- Be French speaker
- Be in a regular class
- Have a diagnosis of epilepsy
Key exclusion criteria (4 listed)
- Subjects schooled in IEM
- Subjects diagnosed with austim spectrum disorder
- Subjects with a motor or visual handicap
- Subjects with psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Score in the different tests assessing oral language
Time frame: day 1
Test assessing oral language : * Oral naming of images * Oral designation of images * Morphosyntactic comprehension test * Syntactic production test The scores obtained in the various tests are organized into 7 classes: Class 1 = percentiles less than 7 : "pathological" zone Class 2 = 7 to 20 percentiles : "fragile" zone / "weak" zone Class 3 = 21 to 38 percentiles : "low standard" zone Class 4 = percentiles 39 to 62 : "median standard" zone / expected average results for age or grade level Class 5 = 63 to 80 percentiles : "higher standard" zone Classes 6 and 7 = respectively 81 to 93 percentiles and percentiles greater than 93 : zone with results well above the norm for age or grade level.
1 secondary outcome
Score in the different tests assessing attention
Time frame: day 1
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 12 Apr 2022.
- Individual participant dataSharing planned: Undecided. NC
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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.
Maxime colmard, résident principal investigator
UH MONTPELLIER
Moritz-Gasser Sylvie study chair
UH MONTPELLIER
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 Epilepsy Syndrome, run by University Hospital, Montpellier at 1 site in France.
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 5 inclusion and 4 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 12 Apr 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 France. 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?
Score in the different tests assessing oral language (time frame: day 1). 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 12 Apr 2022.