Music Perception in SeLECTs (EpiMUS)

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: Recruiting
• Conditions: Rolandic Epilepsy
• Intervention / Treatment: Other: Patients

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: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Maria PAPADOPOULOU, MD; Phone Number: 04 27 85 65 78; Email: maria.papadopoulou@chu-lyon.fr
• Study Contact Backup: Name: Anne CACLIN, PhD; Phone Number: 04.72.13.89.04; Email: anne.caclin@inserm.fr

Study Locations

• France
  • Bron, France, 69500
    • Recruiting
    • Hospices Civils de Lyon
    • Contact: Maria PAPADOPOULOU, MD; Email: maria.papadopoulou@chu-lyon.fr
  • Bron, France, 69500
    • Not yet recruiting
    • Centre Hospitalier Le Vinatier (Bât. 452),
    • Contact: Anne CACLIN

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Performance obtained in melodic tasks	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	Comparison between controls and patients using Bayesian ANOVAs to response times obtained with melodic tasks;	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	2 Years
Performance obtained in rhythmic tasks	Comparison between controls and patients using Bayesian ANOVAs to response times obtained with rhythmic tasks.	2 Years

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: August 5, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Epilepsy; music; language; neurology; childhood; rhythm; pitch
• Additional Relevant MeSH Terms: Epileptic Syndromes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsies, Partial; Epilepsy; Epilepsy, Rolandic
• Other Study ID 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