N/A
N=12
MRI for Non-invasive Evaluation of Brain Stress
Craniosynostosis
Bottom Line
View on ClinicalTrials.gov: NCT01898650 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Blood Flow and Perfusion — 26.8 ml/min/100g — p=0.004
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MR scan (Other)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Flow and Perfusion |
26.8 | 0.004 sig |
Summary
Craniosynostosis is a birth defect that causes the bones on a baby's head to fuse together earlier than normal. This causes the baby to have an abnormally shaped head. These children are operated on to prevent or treat increased pressure on the brain, allowing for normal development. There is not good evidence of which children with craniosynostosis have increased pressure on the brain. Up to twenty patients with craniofacial abnormalities will be enrolled in this pilot study. The investigators will use a magnetic resonance scanner to obtain several measures of brain metabolism. The investigators will also obtain data which are markers of developmental delay.
The results will also be compared to age and gender matched data from children without craniofacial abnormalities.
There study hypothesis is that patients with craniofacial abnormalities associated with intracranial pressure will have decreased metabolic activity compared to control patients.
Eligibility Criteria
Inclusion Criteria
- patients presenting to the Plastic Surgery or Neurosurgery clinics with scheduled sedated MRI and abnormalities such as hydrocephalus (and possibly some patients to be used as controls who present to the clinic with no known skull or brain abnormalities)
Exclusion Criteria
- history of abnormalities known to affect brain topology or function
- implants (e.g. pacemakers) that might rule out use of MR scanning.
Data sourced from ClinicalTrials.gov (NCT01898650). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.