Clinical trial Recruiting at 1 site Interventional Ages 7 to 12

Analyzing Velopharyngeal Motor Skills in Children with Cleft Palate Using MRI

Official title: Etiological Study of Persistent Velopharyngeal Insufficiency in Children With Operated Velopalatine Cleft by Analysis of Velopharyngeal Motor Skills in Static and Dynamic MRI

Run by Centre Hospitalier Universitaire, Amiens · NCT06072495 · Data updated 2026-11-12

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

Study typeInterventional
Ages7 Years to 12 Years
SexAll
Enrollment30 (estimated)
SponsorCentre Hospitalier Universitaire, Amiens
Academic / other
Locations1 site (Amiens)
StatusRecruiting
StartedNovember 6, 2024
Main results expectedJune 2026
Study endsJune 2026
Registry record updatedJune 15, 2026
Trial IDNCT06072495 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • CHU Amiens-Picardie
    Amiens, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.