Analyzing Velopharyngeal Motor Skills in Children with Cleft Palate Using MRI
Etiological Study of Persistent Velopharyngeal Insufficiency in Children With Operated Velopalatine Cleft by Analysis of Velopharyngeal Motor Skills in Static and Dynamic MRI
This study is trying to see how well the muscles in the throat work in children with cleft palate to help understand why some still have trouble speaking after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 7 Years to 12 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Trial ID | NCT06072495 on ClinicalTrials.gov |
What this trial studies
This study investigates persistent velopharyngeal insufficiency (VPI) in children who have undergone surgery for cleft palate. By utilizing real-time MRI, the research aims to analyze the motor skills of the velopharyngeal muscles and assess their morphology, positioning, and symmetry. The goal is to identify the underlying causes of VPI in these patients, which could lead to personalized rehabilitation and surgical strategies. The study focuses on children aged 7 to 12 years who have had specific surgical interventions at the Amiens University Hospital.
Who should consider this trial
Good fit: Ideal candidates are French-speaking children aged 7 to 12 years with isolated cleft lip or velopalatal cleft who have undergone specific surgical procedures at the Amiens University Hospital.
Not a fit: Patients with syndromic clefts, severe neurological disorders, or those who have not followed their surgical schedule may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide tailored treatment options for children suffering from VPI, improving their speech and quality of life.
How similar studies have performed: While the use of MRI in analyzing velopharyngeal function is gaining traction, this specific approach to understanding VPI in cleft palate patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children aged 7 to 12 years with Isolated cleft lip * isolated velopalatal cleft * Without a diagnosis of syndromic cleft or Pierre Robin sequence * French speaking, and French is the native language * Operated with a cheiloplasty (for cleft lip) or an intravelar Veloplasty (according to Sommerlad) at the Amiens University Hospital * Whose follow-up is done at the Amiens University Hospital Exclusion Criteria: * Refusal of the parents and/or the patient * With a contraindication to MRI * Whose follow-up was initiated in another center and/or whose surgery was performed in another center * Whose surgical schedule has not been followed * Patient with severe neurological or neuropsychiatric disorders or Severe speech and language delay not related to the cleft anatomy * Patients treated with fixed, non-removable orthodontic treatment.
Where this trial is running
Amiens
- CHU Amiens-Picardie — Amiens, France (Recruiting)
Study contacts
- Study coordinator: Cica-Carole GBAGUIDI, MD
- Email: Gbaguidi.Cica-Carole@chu-amiens.fr
- Phone: 0322089050
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.