MRI for Non-invasive Evaluation of Brain Stress

NCT01898650 | Completed Results

• 1 other identifier: 201208086
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Craniosynostosis

Keywords

craniosynostosis; sagittal synostosis; metopic synostosis; coronal synostosis; lambdoid synostosis

Outcome Measures

Primary Outcomes (1)

• Blood Flow and Perfusion

  To be measured with both oxygen extraction fraction and arterial spin labeling to measure blood flow.

  during the single MRI scan, approximately 30 - 45 minutes

Study Arms (1)

craniofacial abnormalities

EXPERIMENTAL

Subjects with craniosynostosis or other craniofacial abnormalities associated with ICP who will undergo an MR scan.

Other: MR scan

Interventions

MR scan OTHER

craniofacial abnormalities

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• history of abnormalities known to affect brain topology or function
• implants (e.g. pacemakers) that might rule out use of MR scanning.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Craniosynostoses

Condition Hierarchy (Ancestors)

Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

A primary limitation of this study is the small sample size and the variability between subjects with respect to their diagnosis and condition.

Results Point of Contact

• Title: Gary Skolnick
• Organization: Washington University School of Medicine

gskolnic@wustl.edu

13144544005

Study Officials

• Kamlesh Patel, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: individual participants will serve as their own controls by using affected and unaffected regions of the brain for paired analysis

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: July 12, 2013
• Study Start: January 30, 2013
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: May 23, 2023
• Results First Posted: February 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)