Music Perception in SeLECTs (EpiMUS)

December 4, 2024 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Bron, France, 69500
      • Bron, France, 69500
        • Not yet recruiting
        • Centre Hospitalier Le Vinatier (Bât. 452),
        • Contact:
          • Anne CACLIN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

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.

Exclusion Criteria:

  • Major cognitive impairment or inability to understand and apply instructions
  • Individuals refusing to participate in the study
  • Pregnant or breastfeeding minors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: 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.
Controls
This group consists of healthy individuals between 5 and 14 years old, with no history of epilepsy and/or other neurodevelopmental disorders.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
2 Years
Performance obtained in melodic tasks
Time Frame: 2 Years
Comparison between controls and patients using Bayesian ANOVAs to response times obtained with melodic tasks;
2 Years
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
2 Years
Performance obtained in rhythmic tasks
Time Frame: 2 Years
Comparison between controls and patients using Bayesian ANOVAs to response times obtained with rhythmic tasks.
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 13, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 69HCL24_0084

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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