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

NCT ID: NCT06072495

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-12-31

Brief Summary

Velopharyngeal insufficiency is defined as the inability of the soft palate to isolate the nasopharynx from the oropharynx. It is a frequent sequela in patients with a velopalatine cleft despite anatomical restoration of the soft palate by intravelar veloplasty at 6 months. If rehabilitation by a speech therapist is not successful, a pharyngoplasty can be discussed. In the last ten years, MRI was used in dynamic and static way, to analyzed velopharyngeal muscles, in particular Levator Veli Palatini. MRI could be used to identify the etiology of VPI in those patients, and thus allow personalized rehabilitation and surgical management. The aim of this study is to examine the differences in velopharyngeal motricity as well as velar muscles morphology, positioning, and symmetry of children with repaired cleft palate with different degrees of severity of velopharyngeal insufficiency (VPI), and children with labial cleft (noncleft palate anatomy).

Conditions

Velopharyngeal Insufficiency; Real Time MRI; Cleft Palate

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

child with operated isolated labial cleft

Group Type: EXPERIMENTAL

real time MRI

Intervention Type: OTHER

ubjects will be scanned in the supine position using ACHIEVA 3T TX DStream Philips® and a 33 channels head and neck coil. An elastic strap will be fixed to the forehead to limits movement during scan. Headset will be used to cancel the loud MRI noise and to communicate with the subjects

child with isolated operated velopalatal cleft with severe VPI ( IIB//IIM) and normal velum anatomy

Group Type: EXPERIMENTAL

real time MRI

Intervention Type: OTHER

ubjects will be scanned in the supine position using ACHIEVA 3T TX DStream Philips® and a 33 channels head and neck coil. An elastic strap will be fixed to the forehead to limits movement during scan. Headset will be used to cancel the loud MRI noise and to communicate with the subjects

child with isolated operated velopalatal cleft with soft VPI (I/I-II) and abnormal velum anatomy

Group Type: EXPERIMENTAL

real time MRI

Intervention Type: OTHER

ubjects will be scanned in the supine position using ACHIEVA 3T TX DStream Philips® and a 33 channels head and neck coil. An elastic strap will be fixed to the forehead to limits movement during scan. Headset will be used to cancel the loud MRI noise and to communicate with the subjects

child with isolated operated velopalatal cleft with normal anatomy and soft VPI

Group Type: EXPERIMENTAL

real time MRI

Intervention Type: OTHER

ubjects will be scanned in the supine position using ACHIEVA 3T TX DStream Philips® and a 33 channels head and neck coil. An elastic strap will be fixed to the forehead to limits movement during scan. Headset will be used to cancel the loud MRI noise and to communicate with the subjects

Interventions

real time MRI

ubjects will be scanned in the supine position using ACHIEVA 3T TX DStream Philips® and a 33 channels head and neck coil. An elastic strap will be fixed to the forehead to limits movement during scan. Headset will be used to cancel the loud MRI noise and to communicate with the subjects

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Amiens-Picardie

Amiens, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Cica-Carole GBAGUIDI, MD

Role: CONTACT

Gbaguidi.Cica-Carole@chu-amiens.fr

0322089050

Facility Contacts

Cica-Carole Gbaguidi, MD

Role: primary

Gbaguidi.Cica-Carole@chu-amiens.fr

0322089050

Other Identifiers

PI2021_843_0208

Identifier Type: -

Identifier Source: org_study_id