TerminatedNot Applicable

Neurodevelopmental Outcomes in Craniosynostosis Repair

Stopped: Enrollment issues

United States9 participantsStarted 2021-07-08

Plain-language summary

Context: Craniosynostosis is a common craniofacial abnormality which can be associated with various clinical syndromes. Though it has been established that children with craniosynostosis score lower on certain developmental tests, the effect of craniosynostosis and cranioplasty surgery on the neural circuitry and brain development is less well known or understood. Objectives: The purpose of this study is to describe the effect of cranial vault remodeling in children with craniosynostosis on white matter tracts with tractography and Diffusion tensor imaging (DTI), functional MRI, and neurodevelopmental tests, before and after surgery as compared to age-matched controls. Study Design: This will be a prospective study of patients diagnosed with craniosynostosis and who are going to have open or endoscopic cranial vault remodeling (CVR). Study Measures: The study will measure MRI sequences before and after surgery and at set time intervals to quantify the effect of white matter tract maturity. Parallel to this, neurodevelopmental tests will be administered at these same intervals.

Who can participate

Age range4 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Up to 500 children, for all subjects, age of initial study entry: one test group between 3-6 months old( endoscopic assisted) , and the other 6-24 months of age ( open CVR) ) once enrolled, children will be included until 4 years of age. * Diagnosed with craniosynostosis, single or multiple suture * Babies with craniosynostosis syndrome including but not limited to Pfieffers, Aperts, Crouzons,and Menkes. * Approximately 60 age-matched controls (3 in each group) not diagnosed with craniosynostosis syndrome, stratified by age groups starting at 3 months, 5 months, 7 months, 9 month 11 months, 13 months, 15 months, 17 months, 19 months, then every 3 months, 22 months, 25 months, 28 months, 31 months, 34 months, 37 months,40 months,43 months,46 months,49 months. Exclusion Criteria: * Children not meeting the inclusion criteria * Children with traumatic brain injury, brain cancer, or VP shunt that could affect development. * Children who have already undergone CVR repair * Developmentally Normal children who cannot undergo or cannot be still for an awake or asleep non-sedated MRI

What they're measuring

Assessment of Brain Development Via Diagnostic Imaging

Timeframe: From 2 months age to 4 years of age

Assessment of the Change in White Matter Tract Organization After Cranial Vaut Remodeling Surgery (CVR)

Timeframe: From 2 months age to 4 years of age

Trial details

NCT IDNCT04072783

SponsorUniversity of Arkansas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

Results submitted2025-12-16