Cranial Vault Remodeling Surgery for Craniosynostosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how cranial vault remodeling surgery affects brain development in children with craniosynostosis, a condition where a baby's skull bones fuse too early, impacting brain growth. Researchers will use brain imaging techniques like MRI (Magnetic Resonance Imaging) and functional MRI to observe changes in brain structure and function before and after surgery. Children diagnosed with craniosynostosis, whether they have a related syndrome or not, and who are scheduled for this surgery, might be a good fit for the trial. The study will compare these children to peers without the condition to assess the surgery's impact on development.
As an unphased trial, this study offers a unique opportunity to contribute to understanding how surgery can aid brain development in affected children.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that cranial vault remodeling surgery is safe for children with craniosynostosis?
Research has shown that cranial vault remodeling surgery is generally well-tolerated in children with craniosynostosis. This surgery reshapes the skull and is often performed on infants under one year old to correct the premature fusion of skull bones. While risks exist, as with any surgery, they are usually manageable.
Some children may experience developmental delays or learning challenges after the surgery, but outcomes can vary. This surgery is a common treatment for craniosynostosis, widely used and considered relatively safe for correcting the condition.
The surgery aims to help the child's skull and brain develop properly by addressing the early closure of the joints between the skull bones. Although some risk is inherent in any surgery, cranial vault remodeling is a well-established procedure for treating craniosynostosis.12345Why are researchers excited about this trial?
Researchers are excited about the use of advanced imaging techniques like DTI, functional MRI, and MRI in cranial vault remodeling surgery for craniosynostosis because these methods offer a detailed view of the brain’s structure and function. Unlike traditional imaging that might only show basic bone structures, these advanced imaging techniques can provide insights into how the surgery affects neurodevelopment and brain activity. This could lead to better understanding and improved outcomes for patients by tailoring surgical approaches based on detailed brain data.
What evidence suggests that cranial vault remodeling surgery is effective for craniosynostosis?
Research has shown that cranial vault remodeling surgery can greatly improve skull shape in children with craniosynostosis. In one study with follow-ups from 7 to 42 months, all children showed noticeable improvements in skull shape. This surgery also correlates with enhanced thinking and learning abilities, addressing some developmental delays and learning problems often associated with craniosynostosis. Although the long-term effects on brain development are still under investigation, early findings suggest the surgery benefits crucial brain pathways needed for learning and communication. Participants in this trial will undergo pre- and post-operative imaging studies to further explore these effects.24567
Who Is on the Research Team?
Eylem Ocal, MD
Principal Investigator
University of Arkansas
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative Assessment
Participants undergo pre-operative imaging studies and neurodevelopmental tests
Surgery and Immediate Post-operative
Participants undergo cranial vault remodeling surgery and immediate post-operative care
Post-operative Follow-up
Participants undergo post-operative imaging studies and neurodevelopmental tests at set intervals
Long-term Follow-up
Participants are monitored for long-term neurodevelopmental outcomes and white matter tract changes
What Are the Treatments Tested in This Trial?
Interventions
- DTI
- Functional MRI
- MRI
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Arkansas
Lead Sponsor