Rolandic EpilepsyEpiMUSNCT06545708
Music Perception in SeLECTs
An observational study of Rolandic Epilepsy, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Self-limited epilepsy with centrotemporal spikes (SeLECTS) is the most frequent epilepsy syndrome in children between the ages of 4 and 13 years. SeLECTS is associated in 15 to 30% of patients with specific cognitive deficits, including in particular disorders in language, visuo-spatial memory, declarative memory, and… Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Rolandic Epilepsy
- What is being tested?
- Patients
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 13 Nov 2024to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: The participants will be recruited from a population of 5 to 14 years of age. 50 healthy control participants will be recruited by posting flyers and/or by electronic message, and 50 epileptic patients will be recruited within the HFME child epileptology department (HCL). Their inclusion will be made at the CRNL or HFME by one of the study investigators.
Who may be able to join
- Subject aged between 5 and 14 years old
- Non-opposition of parents or guardians for the child's participation in the study
- No major cognitive impairment and ability to understand and apply instructions
- Subject affiliated to a social security scheme
- Subject motivated to participate in the project
- Proficiency with the French language
Show all 11Show fewer
- For the group of control participants:
- Without neurological or psychiatric history
- For the group of participants with seizure disorder:
- No neurological (except EPCT) or psychiatric history
- Diagnosis of self-limited epilepsy with centro-temporal spikes (PTSE) by a qualified healthcare professional.
Who cannot join
- Major cognitive impairment or inability to understand and apply instructions
- Individuals refusing to participate in the study
- Pregnant or breastfeeding minors
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
Centre Hospitalier Le Vinatier (Bât. 452),
Bron, Bron, 69500
Anne CACLIN
- Recruiting
Hospices Civils de Lyon
Bron, Bron, 69500
Maria PAPADOPOULOU, MD, maria.papadopoulou@chu-lyon.fr
About this study
Official title: Music and Cognitive Deficits in Self-Limited Epilepsy with Centrotemporal Spikes
Self-limited epilepsy with centrotemporal spikes (SeLECTS) is the most frequent epilepsy syndrome in children between the ages of 4 and 13 years. SeLECTS is associated in 15 to 30% of patients with specific cognitive deficits, including in particular disorders in language, visuo-spatial memory, declarative memory, and attention. SeLECTS has the potential to evolve into Landau-Kleffner syndrome, the most extreme form of SeLECTS including symptoms of auditory agnosia and aphasia, with potential risks of persistent neuropsychological impairments. In a recent study in adults who had suffered Landau-Kleffner syndrome during childhood, the investigators have shown that these patients, in addition to their known deficit in verbal short-term memory, also exhibit persistent musical difficulties during adulthood, with in particular deficit in melody and rhythm short-term memory.
In the present project, the investigators intend to enlarge the understanding of cognitive deficits generated by SeLECTS in children by investigating the integrity of music perception, both for melody and rhythm. To date, data about music perception in children with epilepsy are scarce and we do not know how distinct components of melody and rhythm perception and memory may be altered.
Read the detailed description
Self-limited epilepsy with centrotemporal spikes (SeLECTS) is the most frequent epilepsy syndrome in children between the ages of 4 and 13 years. The defining electroclinical feature of SeLECTS is the presence of centrotemporal spikes on EEG between seizures. SeLECTS is associated with specific cognitive deficits in 15 to 30% of patients, including disorders in language, visuo-spatial memory, explicit memory, and attention. The centrotemporal spikes are activated in sleep and, in rare cases, the condition has the potential to evolve into an Epileptic Encephalopathy with spike- and- wave activation in sleep (EE-SWAS), including Landau-Kleffner syndrome. The latest is characterized by symptoms of auditory agnosia and aphasia, with potential risks of persistent neuropsychological impairments. In a previous study, it has been shown that these patients also exhibit persistent musical difficulties.
In the present project, the investigators intend to enlarge the understanding of cognitive deficits generated by SeLECTS in children by analyzing the integrity of music perception, both for melody and rhythm, as well as testing the potential of a musical intervention for auditory and cognitive training in children suffering from SeLECTS.
The current research plan is to explore music perception in this specific epilepsy syndrome, with behavioral testing (Experiment 1) and neuroimaging using functional Near-Infrared Spectroscopy (fNIRS) (Experiment 2), and on the long run, informed by this exploration and previous studies, the design of a musical therapeutic intervention is envisioned in order to evaluate the impact of this program on music perception, language, and memory.
- Conditions
- Rolandic Epilepsy
- Being tested
- Patients
- Keywords
- Epilepsy, music, childhood, neurology, rhythm, pitch, language
- Medical subject headings
- Epilepsy, Rolandic, Epilepsy, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PatientsOther
This group consists of children and adolescents between the ages of 5 and 14, diagnosed with self-limited epilepsy with centrotemporal spikes by a medical professional (epileptologist or neurologist), and in the active phase of the disorder.
| Study group | Role | What they receive |
|---|---|---|
| Patients | This group consists of children and adolescents between the ages of 5 and 14, diagnosed with self-limited epilepsy with centrotemporal spikes by a medical professional (epileptologist or neurologist), and in the active phase of the disorder. Receives: Other: Patients | |
| Controls | This group consists of healthy individuals between 5 and 14 years old, with no history of epilepsy and/or other neurodevelopmental disorders. Receives: Other: Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance obtained in melodic tasks
Comparison between controls and patients using Bayesian ANOVAs to the percentages of correct responses obtained with melodic tasks
Measured: 2 Years
Performance obtained in melodic tasks
Comparison between controls and patients using Bayesian ANOVAs to response times obtained with melodic tasks;
Measured: 2 Years
Performance obtained in rhythmic tasks
Comparison between controls and patients using Bayesian ANOVAs to the percentages of correct responses obtained with rhythmic tasks
Measured: 2 Years
Performance obtained in rhythmic tasks
Comparison between controls and patients using Bayesian ANOVAs to response times obtained with rhythmic tasks.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start13 Nov 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rolandic EpilepsyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545708
- Sponsor's protocol ID
- 69HCL24_0084
- Acronym
- EpiMUS
- Status last verified
- Dec 2024
- First submitted
- 10 Jul 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music and Cognitive Deficits in Self-Limited Epilepsy with Centrotemporal Spikes
- ClinicalTrials.gov ID
- NCT06545708
- Acronym / sponsor ID
- EpiMUS / 69HCL24_0084
- Conditions
- Rolandic Epilepsy
- Keywords
- Epilepsy, music, childhood, neurology, rhythm, pitch, language
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 9 Aug 2024 (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.
Self-limited epilepsy with centrotemporal spikes (SeLECTS) is the most frequent epilepsy syndrome in children between the ages of 4 and 13 years. SeLECTS is associated in 15 to 30% of patients with specific cognitive deficits, including in particular disorders in language, visuo-spatial memory, declarative memory, and attention. SeLECTS has the potential to evolve into Landau-Kleffner syndrome, the most extreme form of SeLECTS including symptoms of auditory agnosia and aphasia, with potential risks of persistent neuropsychological impairments. In a recent study in adults who had suffered Landau-Kleffner syndrome during childhood, the investigators have shown that these patients, in addition to their known deficit in verbal short-term memory, also exhibit persistent musical difficulties during adulthood, with in particular deficit in melody and rhythm short-term memory.
In the present project, the investigators intend to enlarge the understanding of cognitive deficits generated by SeLECTS in children by investigating the integrity of music perception, both for melody and rhythm. To date, data about music perception in children with epilepsy are scarce and we do not know how distinct components of melody and rhythm perception and memory may be altered.
Detailed description
Self-limited epilepsy with centrotemporal spikes (SeLECTS) is the most frequent epilepsy syndrome in children between the ages of 4 and 13 years. The defining electroclinical feature of SeLECTS is the presence of centrotemporal spikes on EEG between seizures. SeLECTS is associated with specific cognitive deficits in 15 to 30% of patients, including disorders in language, visuo-spatial memory, explicit memory, and attention. The centrotemporal spikes are activated in sleep and, in rare cases, the condition has the potential to evolve into an Epileptic Encephalopathy with spike- and- wave activation in sleep (EE-SWAS), including Landau-Kleffner syndrome. The latest is characterized by symptoms of auditory agnosia and aphasia, with potential risks of persistent neuropsychological impairments. In a previous study, it has been shown that these patients also exhibit persistent musical difficulties.
In the present project, the investigators intend to enlarge the understanding of cognitive deficits generated by SeLECTS in children by analyzing the integrity of music perception, both for melody and rhythm, as well as testing the potential of a musical intervention for auditory and cognitive training in children suffering from SeLECTS.
The current research plan is to explore music perception in this specific epilepsy syndrome, with behavioral testing (Experiment 1) and neuroimaging using functional Near-Infrared Spectroscopy (fNIRS) (Experiment 2), and on the long run, informed by this exploration and previous studies, the design of a musical therapeutic intervention is envisioned in order to evaluate the impact of this program on music perception, language, and memory.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: PatientsThis group consists of children and adolescents between the ages of 5 and 14, diagnosed with self-limited epilepsy with centrotemporal spikes by a medical professional (epileptologist or neurologist), and in the active phase of the disorder. |
| Controls | – | Other: PatientsThis group consists of healthy individuals between 5 and 14 years old, with no history of epilepsy and/or other neurodevelopmental disorders. |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The participants will be recruited from a population of 5 to 14 years of age. 50 healthy control participants will be recruited by posting flyers and/or by electronic message, and 50 epileptic patients will be recruited within the HFME child epileptology department (HCL). Their inclusion will be made at the CRNL or HFME by one of the study investigators.
Key inclusion criteria (11 listed)
- Subject aged between 5 and 14 years old
- Non-opposition of parents or guardians for the child's participation in the study
- No major cognitive impairment and ability to understand and apply instructions
- Subject affiliated to a social security scheme
- Subject motivated to participate in the project
Key exclusion criteria (3 listed)
- Major cognitive impairment or inability to understand and apply instructions
- Individuals refusing to participate in the study
- Pregnant or breastfeeding minors
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 |
|---|---|---|
| PatientsThis group consists of children and adolescents between the ages of 5 and 14, diagnosed with self-limited epilepsy with centrotemporal spikes by a medical professional (epileptologist or neurologist), and in the active phase of the disorder. | Other | Controls, Patients |
Primary outcome
Performance obtained in melodic tasks
Time frame: 2 Years
Comparison between controls and patients using Bayesian ANOVAs to the percentages of correct responses obtained with melodic tasks
Performance obtained in melodic tasks
Time frame: 2 Years
Comparison between controls and patients using Bayesian ANOVAs to response times obtained with melodic tasks;
Performance obtained in rhythmic tasks
Time frame: 2 Years
Comparison between controls and patients using Bayesian ANOVAs to the percentages of correct responses obtained with rhythmic tasks
Performance obtained in rhythmic tasks
Time frame: 2 Years
Comparison between controls and patients using Bayesian ANOVAs to response times obtained with rhythmic tasks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Rolandic Epilepsy
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rolandic Epilepsy, run by Hospices Civils de Lyon at 2 sites 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 11 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria PAPADOPOULOU, MD (04 27 85 65 78, maria.papadopoulou@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance obtained in melodic tasks (time frame: 2 Years). The study lists 4 primary outcomes in all. 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 9 Dec 2024; AzTrials last refreshed its copy on 27 Oct 2026.