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CraniosynostosisNCT01898650

MRI for Non-invasive Evaluation of Brain Stress

A study testing MR scan in people with Craniosynostosis, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 18 yearsHealthy volunteers can take part
Conditions the study is for
Craniosynostosis
What is being tested?
MR scan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
30 Jan 2013to Jul 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • St. Louis Children's Hospital

    St Louis, Missouri, 63110

Other trials in United States

About this study

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.

Read the detailed description

The incidence of craniosynostosis is reported to be 1/2,000 births. Craniosynostosis is a birth defect that causes one or more sutures on a baby's head to close earlier than normal. The skull of an infant or young child is made up of bony plates that allow for growth of the skull. The borders at which these plates intersect are called sutures or suture lines. Early closing of a suture causes the baby to have an abnormally shaped head.

Original contributions by Dr. Paul Tessier along with technological advances (improved pediatric anesthesia, rigid fixation, resorbable plates, endoscopic techniques and distraction) have significantly advanced surgical treatment for these patients over the past 40 years.

Primary indication for operative treatment for patients with craniosynostosis is to prevent or treat increased intracranial pressure (ICP) and avoid neurological impairment. Increased ICP is thought to result from restricted space for brain growth caused by decreased cranial vault volume. A secondary surgical indication is normalization of head shape for cosmetic purposes.

Literature is limited on the relationship between craniosynostosis and ICP. The most widely reported study is by Renier and colleagues. In 75 patients preoperative ICP monitoring was performed using an epidural sensor. They identified ICP to be normal in one-third of the cases, obviously elevated in one-third, and borderline in one-third. When counseling patients, practitioners report a 13% rate of increased ICP for single suture synostosis and 42% for multiple suture synostosis. However, the authors used adult normative values for ICP (normal less than 10mmHg and elevated greater than 15mmHg). Normal ICP in children and infants has been identified to be closer to 6 mmHg.

Due to the invasiveness of the test, preoperative ICP monitoring is not routinely performed to decide if operative repair is required. Other indirect signs of increased intracranial pressure have been described (e.g., copper beaten appearance of the skull on plain film, papilledema, comparing intracranial volume to normative data), but are not reliable. Currently, the standard of care is to surgically treat all patients with craniosynostosis.

While it is not currently feasible to measure ICP directly, we may be able to indirectly study the effects of growth restriction on brain development. Metabolic consequences of direct mechanical stress and global cerebral ischemia in craniosynostosis have not been described. We aim to evaluate the prevalence of metabolic defects in craniosynostosis patients through the use of magnetic resonance (MR) imaging techniques.

Up to twenty patients with craniosynostosis or other abnormalities such as hydrocephaly which are associated with increased cranial pressure will be enrolled in this pilot study. The investigators will obtain several measures of cerebral metabolism preoperatively. MR spectroscopy (MRS) will be used to obtain concentrations of N-acetyl aspartate (NAA) and lactate. NAA is a highly sensitive marker of brain injury and the presence of lactate can indicate compromised metabolism. We will measure whole-brain oxygen extraction (OEF) using a magnetic field mapping approach. Elevated OEF is a key indicator of compromised perfusion. Cerebral blood flow (CBF) will be measured using an arterial spin labeling (ASL) sequence, which will allow direct measurement of perfusion deficiencies. We will also obtain functional connectivity data using an rfcMRI sequence, which is sensitive to developmental delay. Finally, a scanner sequence which measures CSF flow as a marker of intracranial pressure will also be performed.

The results will also be compared to deidentified age and gender matched normative data. These controls will be recruited in the plastic surgery clinic and/or deidentified data from normal subjects from another study will be used. The analysis for OEF and ASL data will be performed by Dr. Dustin Ragan and Dr. McKinstry at Washington University in St. Louis.

Being tested
MR scan
Keywords
craniosynostosis, sagittal synostosis, metopic synostosis, coronal synostosis, lambdoid synostosis
Medical subject headings
Craniosynostoses

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MR scanOther

Study groups in NCT01898650
Study groupRoleWhat they receive
craniofacial abnormalitiesExperimentalSubjects with craniosynostosis or other craniofacial abnormalities associated with ICP who will undergo an MR scan.
Receives: Other: MR scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood Flow and Perfusion

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

    Measured: during the single MRI scan, approximately 30 - 45 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2013 (estimated)
  2. Study start30 Jan 2013
  3. Primary completionJul 2017
  4. Study completionJul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01898650
Sponsor's protocol ID
201208086
Status last verified
May 2023
First submitted
6 Dec 2012
Last updated
23 May 2023
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing MR scan in people with Craniosynostosis, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood Flow and Perfusion (time frame: during the single MRI scan, approximately 30 - 45 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.

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