Craniosynostoses Clinical Trial
Official title:
Neurodevelopmental Outcomes in Craniosynostosis Repair
NCT number | NCT04072783 |
Other study ID # | 217610 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 8, 2021 |
Est. completion date | December 31, 2024 |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2024 |
Est. primary completion date | July 24, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 4 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
Lead Sponsor | Collaborator |
---|---|
University of Arkansas |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of brain development via diagnostic imaging | Will establish pilot data to establish a normative curve of white-matter tract development in normal children under 4 years of age using (DTI). Fractional anisotropy (FA) (a main DTI parameter sensitive to white matter integrity) maps will be created to achieve a normative "white matter change curve" with from infancy to pre-school age. | From 2 months age to 4 years of age | |
Primary | Assessment of the change in white matter tract organization after cranial vaut remodeling surgery (CVR) | Will quantify the change in white matter tract organization after cranial vault remodeling (CVR) surgery in patients with craniosynostosis by analyzing pre- and post-operative DTI data. This experimental cohort will also be examined in comparison to age-matched controls, pooled with other centers and compared with published data sets of normal babies from the Baby Connectome Project. . The imaging will be repeated at three intervals after surgery leading up to approximately 4 years of age. | From 2 months age to 4 years of age | |
Secondary | Assessment of neurodevelopmental test results in craniosynostosis patients | Will assess neurodevelopmental test results in craniosynostosis patients and seek to correlate these findings with white matter tract changes | From 2 months of age to 4 years of age |
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