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NCT04072783 · ClinicalTrials.gov registry record · NA
Neurodevelopmental Outcomes in Craniosynostosis Repair
A NA study, sponsored by University of Arkansas.
- Terminated
- Registry status
- NA
- Development phase
- 9
- Enrollment target
NCT04072783 is a NA study that was terminated before completion, run by University of Arkansas. The registered enrollment target is 9 participants.
The verdict
NCT04072783, a NA study, was terminated before completion, sponsored by University of Arkansas.
- TERMINATED
- Registry status
- NA
- Development phase
- 9 participants
- Enrollment target
Study 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.
Interventions
- DIAGNOSTIC_TEST MRI,DTI, functional MRI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2021-07-08 |
| Est. Completion | 2024-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04072783
The ClinicalTrials.gov registry entry for NCT04072783 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arkansas, which has 318 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which MRI,DTI, functional MRI is the first listed.
NCT04072783 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04072783 about?
NCT04072783 is a clinical study titled "Neurodevelopmental Outcomes in Craniosynostosis Repair". 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...
What is the current status of trial NCT04072783?
This trial is currently terminated. It is a NA study. The enrollment target is 9 participants. The study started on 2021-07-08. Estimated completion is 2024-12-31.
What interventions are being tested in trial NCT04072783?
The interventions under investigation include: MRI,DTI, functional MRI (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04072783?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
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