Cranial Vault Remodeling Surgery for Craniosynostosis

Overseen By Eylem Ocal, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Arkansas

Disqualifiers: Traumatic brain injury, brain cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

9 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eylem Ocal, MD

Principal Investigator

University of Arkansas

Eligibility Criteria

This trial is for children up to 4 years old diagnosed with craniosynostosis, a skull condition needing surgery. It includes babies from 3-24 months who will undergo surgery and age-matched controls without the condition. Excluded are those previously treated or unable to have an MRI due to other conditions.

Inclusion Criteria

I have been diagnosed with craniosynostosis.

I am not diagnosed with craniosynostosis and match the age group required.

My baby has a condition where the skull bones fused too early.

Exclusion Criteria

Developmentally Normal children who cannot undergo or cannot be still for an awake or asleep non-sedated MRI.

My child has had surgery to correct craniovertebral junction.

My child has a brain condition that could impact their development.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Assessment

Participants undergo pre-operative imaging studies and neurodevelopmental tests

4 weeks

1 visit (in-person)

Surgery and Immediate Post-operative

Participants undergo cranial vault remodeling surgery and immediate post-operative care

1 week

Hospital stay

Post-operative Follow-up

Participants undergo post-operative imaging studies and neurodevelopmental tests at set intervals

Up to 4 years

3 visits (in-person) at intervals

Long-term Follow-up

Participants are monitored for long-term neurodevelopmental outcomes and white matter tract changes

Up to 4 years

Treatment Details

Interventions

• DTI
• Functional MRI
• MRI

Trial Overview The study tests how surgery affects brain development in kids with craniosynostosis using MRI techniques like DTI and functional MRI, plus developmental tests before/after surgery compared to normal peers.

Participant Groups

Group I: Patients with craniosynostosis Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+