Understanding the genetic causes of language development disorders in children
BASES MOLECULAIRES DU DEVELOPPEMENT DU LANGAGE ORAL ET DES TROUBLES SPECIFIQUES ASSOCIES
This study is trying to find out the genetic reasons behind language development disorders in children to help understand and treat them better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 5 Years and up |
| Sex | All |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France Government |
| Locations | 3 sites (Corbeil-Essonnes and 2 other locations) |
| Trial ID | NCT06660108 on ClinicalTrials.gov |
What this trial studies
This study focuses on children diagnosed with Developmental Language Disorder (DLD) to investigate the genetic underpinnings of this condition. By utilizing high-throughput sequencing, the research aims to distinguish sub-groups of children with language difficulties that are not associated with other known disorders. Eligible participants will undergo a blood draw for genetic analysis, and the study seeks to improve the understanding of DLD by examining a more homogeneous cohort. The goal is to clarify the clinical heterogeneity of language disorders and enhance future research and clinical practices.
Who should consider this trial
Good fit: Ideal candidates are children over five years old with a formal diagnosis of severe and isolated DLD who have received appropriate speech therapy.
Not a fit: Patients with cognitive impairments or co-occurring disorders such as autism spectrum disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better diagnostic tools and targeted interventions for children with Developmental Language Disorder.
How similar studies have performed: While there have been successful studies focusing on genetic causes of other language disorders, this specific approach to DLD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Patients Inclusion Criteria: * Eligible families included at least one child over five years old with a formal diagnosis of severe and isolated DLD according to Phase 2 CATALISE criteria . Patients have undergone age-appropriate speech, language and reading evaluations by a speech-language physician and cognitive evaluations by a neuropsychologist, as well as evaluation by a pediatric neurologist to identify co-occurring developmental disorders (ADHD, ASD…) and a medical geneticist for known genetic disorders and genetic testing recommendations. All children included received appropriate speech therapy for at least one year, with a progress report indicating the persistence of language difficulties. Exclusion Criteria: * Cognitive impairment with non-verbal intellectual quotient (IQ) below 2 SD assessed with the Wechsler Preschool and Primary Scale of Intelligence (WPPSI), or the Wechsler Intelligence Scale for Children (WISC-IV or V) according to the age-appropriateness, ASD, moderate to severe hearing loss, orofacial structural abnormalities, known neurological or genetic disorders at the initial assessment. None of the patients met the diagnostic criteria for CAS according to the ASHA (American Speech-Language-Hearing Association, 2007. Childhood apraxia of speech www.asha.org/policy).
Where this trial is running
Corbeil-Essonnes and 2 other locations
- Hopital Sud Francilien — Corbeil-Essonnes, France (Recruiting)
- Raymond Poincaré- Garches — Garches, France (Recruiting)
- Hopital Necker — Paris, France (Recruiting)
Study contacts
- Study coordinator: Vincent Cantagrel, PhD
- Email: vincent.cantagrel@inserm.fr
- Phone: 33 142754237
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.