N/A Completed N=12 Basic Science

MRI for Non-invasive Evaluation of Brain Stress

craniosynostosis

Source: ClinicalTrials.gov NCT01898650 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2023

Primary outcomePrimary: Blood Flow and Perfusion — 26.8 ml/min/100g — p=0.004

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Blood Flow and Perfusion	26.8	0.004 sig

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.

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.