NCT06545708

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
6mo left

Started Nov 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Nov 2024Nov 2026

First Submitted

Initial submission to the registry

July 10, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

November 13, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

2 years

First QC Date

July 10, 2024

Last Update Submit

December 4, 2024

Conditions

Keywords

Epilepsymusicchildhoodneurologyrhythmpitchlanguage

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

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

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

Interventions

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.

ControlsPatients

Eligibility Criteria

Age5 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Le Vinatier (Bât. 452),

Bron, Bron, 69500, France

NOT YET RECRUITING

Hospices Civils de Lyon

Bron, Bron, 69500, France

RECRUITING

MeSH Terms

Conditions

Epilepsy, RolandicEpilepsyLanguage

Condition Hierarchy (Ancestors)

Epilepsies, PartialBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpileptic SyndromesCommunicationBehavior

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2024

First Posted

August 9, 2024

Study Start

November 13, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

December 9, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations