Neurodevelopmental Outcomes in Craniosynostosis Repair

NCT04072783 | Terminated Results FDA Device

• 1 other identifier: 217610
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Craniosynostoses

Keywords

Craniosynostosis; MRI; DTI; Neurodevelopment

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Assessment of Neurodevelopmental Test Results in Craniosynostosis Patients

  From 2 months of age to 4 years of age

Study Arms (1)

Patients with craniosynostosis

OTHER

Patients with craniosynostosis will undergo pre - and post-operative imaging studies. The surgery will be performed for these patients as standard of care. They will also be tested fro neurodevelopment.

Diagnostic Test: MRI,DTI, functional MRI

Interventions

MRI,DTI, functional MRI DIAGNOSTIC_TEST

1. Patients will undergo testing with Pre- and and post-surgical MRI. The protocol will be Sagittal T1, Axial inversion recovery, T2, fluid-attenuated inversion recovery, susceptibility weighted image, diffusion weighted images, diffusion tensor imaging, resting state fMRI, sagittal 3D GRE / FFE or 3D T1 VIBE and tractography. 2. Once patients are identified, surgery is planned.The standard of care procedures fall into two categories based on age of presentation, clinician judgement and family preference all other things being equal. Both the endoscopic-assisted craniectomy and open CVR are standard of care procedures. Patients self-select into these groups. None of the surgery nor any aspect of it is experimental. 3. Patients are routinely examined for neurodevelopment pre- and post-operatively as part of American Cleft Palate Craniofacial Association guidelines.The Vineland Adaptive Behavior Scales are used up to and including age 4.

Also known as: Neurodevelopmental testing, surgery

Patients with craniosynostosis

Eligibility Criteria

• Age: Up to 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Craniosynostoses

Interventions

Diffusion Tensor Imaging; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological; Investigative Techniques

Results Point of Contact

• Title: Dr Eylem Ocal
• Organization: UAMS

eocal@uams.edu

501-364-2996

Study Officials

• Eylem Ocal, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with craniosynostosis only

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: August 28, 2019
• Study Start: July 8, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 22, 2026
• Results First Posted: April 22, 2026

Record last verified: 2026-02

Locations

US (1)