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MRI for Non-invasive Evaluation of Brain Stress

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01898650
First Posted: July 12, 2013
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Washington University School of Medicine
  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. 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.


Condition Intervention
Craniosynostosis Other: MR scan

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 ]
    NAA is a highly sensitive marker of brain injury.

  • Lactate concentration [ Time Frame: one year ]
    The presence of lactate can indicate compromised metabolism.

  • Blood flow and perfusion [ Time Frame: one year ]
    To be measured with both oxygen extraction fraction and arterial spin labeling to measure blood flow.

  • functional connectivity [ Time Frame: one year ]
    We will measure functional connectivity using an rfcMRI sequence. Functional connectivity is sensitive to developmental delay.

  • Intracranial Pressure (ICP) [ Time Frame: 1/1/2015 ]
    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.


Enrollment: 9
Study Start Date: December 2012
Study Completion Date: July 2017
Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: craniofacial abnormalities
Subjects with craniosynostosis or other craniofacial abnormalities associated with ICP 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01898650


Locations
United States, Missouri
St. Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Kamlesh Patel, MD Washington University School of Medicine
  More Information

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01898650     History of Changes
Other Study ID Numbers: 201208086
First Submitted: December 6, 2012
First Posted: July 12, 2013
Last Update Posted: November 6, 2017
Last Verified: November 2017

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

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