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MRI for Non-invasive Evaluation of Brain Stress

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. Identifier: NCT01898650
Recruitment Status : Completed
First Posted : July 12, 2013
Last Update Posted : April 26, 2019
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Craniosynostosis Other: MR scan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Intervention Model Description: individual participants will serve as their own controls by using affected and unaffected regions of the brain for paired analysis
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: MRI for Non-invasive Evaluation of Brain Stress
Study Start Date : December 2012
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Arm Intervention/treatment
Experimental: craniofacial abnormalities
Subjects with craniosynostosis or other craniofacial abnormalities associated with ICP who will undergo an MR scan.
Other: MR scan

Primary Outcome Measures :
  1. N-acetyl aspartate (NAA) concentration [ Time Frame: one year ]
    NAA is a highly sensitive marker of brain injury.

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

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

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

  5. 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.

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.

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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 identifier (NCT number): NCT01898650

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

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Responsible Party: Washington University School of Medicine Identifier: NCT01898650    
Other Study ID Numbers: 201208086
First Posted: July 12, 2013    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Washington University School of Medicine:
sagittal synostosis
metopic synostosis
coronal synostosis
lambdoid synostosis
Additional relevant MeSH terms:
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Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Congenital Abnormalities