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 type | Interventional |
|---|---|
| Ages | 7 Years to 12 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Status | Recruiting |
| Started | November 6, 2024 |
| Main results expected | June 2026 |
| Study ends | June 2026 |
| Registry record updated | June 15, 2026 |
| Trial ID | NCT06072495 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
- Study coordinator: Cica-Carole GBAGUIDI, MD
- Email: Gbaguidi.Cica-Carole@chu-amiens.fr
- Phone: 0322089050
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Effect of a cleft-adapted bottle with a unidirectional valve on milk intake in infants with cleft palate
This study tests whether using a cleft-adapted bottle with a unidirectional valve helps infants with cleft palate take in more milk than a standard bottle.
-
Palatoplasty techniques using PRF and antibiotic-loaded PRF in cleft palate
This trial tests whether adding autologous PRF or gentamicin-loaded PRF to primary palatoplasty helps kids with unilateral or bilateral cleft palate heal better and have fewer fistulas than standard surgery.
-
Improving nasal-sounding speech and swallowing in head and neck cancer survivors with velopharyngeal dysfunction
This pilot effort tests whether injecting material to 'plump' the back wall of the throat (pharyngeal wall augmentation) can help head and neck cancer survivors with velopharyngeal dysfunction speak less nasally and swallow better.
-
Comparing pain relief methods after cleft palate surgery in children
This study is testing whether short-acting or long-acting pain medications work better for managing pain in young children after cleft palate surgery.
-
Furlow palatoplasty with buccal flap for speech in children with cleft palate
This project compares two palate repair methods to see if Furlow palatoplasty with a buccal myomucosal flap leads to better speech than two-flap palatoplasty in children aged 3–5 with nonsyndromic cleft palate.
-
Comparing two pain management techniques for children undergoing palate surgery
This study is testing two different pain management techniques for kids aged 6-18 who are having palate surgery to see which one helps them feel less pain after the operation.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.