MRI for Non-invasive Evaluation of Brain Stress

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01898650
First received: December 6, 2012
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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. Ten patients with craniosynostosis 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 craniosynostosis.

There study hypothesis is that patients with craniosynostosis will have decreased metabolic activity compared to control patients.


Condition Intervention
Craniosynostosis
Other: MR scan

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: MRI for Non-invasive Evaluation of Brain Stress

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • N-acetyl aspartate (NAA) concentration [ Time Frame: one year ] [ Designated as safety issue: No ]
    NAA is a highly sensitive marker of brain injury.

  • Lactate concentration [ Time Frame: one year ] [ Designated as safety issue: No ]
    The presence of lactate can indicate compromised metabolism.

  • Blood flow and perfusion [ Time Frame: one year ] [ Designated as safety issue: No ]
    To be measured with both oxygen extraction fraction and arterial spin labeling to measure blood flow.

  • functional connectivity [ Time Frame: one year ] [ Designated as safety issue: No ]
    We will measure functional connectivity using an rfcMRI sequence. Functional connectivity is sensitive to developmental delay.

  • Intracranial Pressure (ICP) [ Time Frame: 1/1/2015 ] [ Designated as safety issue: No ]
    Intracranial Pressure as measured by MR data uses a formula that assesses both cerebral blood flow and the flow of cerebral spinal fluid in to and out of the brainstem.


Estimated Enrollment: 20
Study Start Date: December 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: craniosynostosis
Subjects with craniosynostosis who will undergo an MR scan.
Other: MR scan
Active Comparator: normal control
normal control subjects who will undergo an MR scan
Other: MR scan

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients presenting to the Plastic Surgery or Neurosurgery clinics with unrepaired craniosynostosis (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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01898650

Contacts
Contact: Kamlesh Patel, MD 314 747-2629 kpatel23@wustl.edu
Contact: Gary Skolnick, BA 314 454-4005 gskolnic@wustl.edu

Locations
United States, Missouri
St. Louis Children's Hospital Recruiting
St. Louis, Missouri, United States, 63110
Contact: Gary Skolnick, BA    314-454-4005    gskolnic@wustl.edu   
Principal Investigator: Kamlesh Patel, MD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Kamlesh Patel, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01898650     History of Changes
Other Study ID Numbers: 201208086
Study First Received: December 6, 2012
Last Updated: July 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
craniosynostosis
sagittal synostosis
metopic synostosis
coronal synostosis
lambdoid synostosis

Additional relevant MeSH terms:
Craniosynostoses
Bone Diseases
Bone Diseases, Developmental
Congenital Abnormalities
Craniofacial Abnormalities
Dysostoses
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Plagiocephaly
Synostosis

ClinicalTrials.gov processed this record on October 22, 2014