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.
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
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.
- Conditions
- Craniosynostosis
- 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 group | Role | What they receive |
|---|---|---|
| craniofacial abnormalities | Experimental | Subjects 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.
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.
- First posted12 Jul 2013 (estimated)
- Study start30 Jan 2013
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CraniosynostosisStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kamlesh Patel, MD, Principal investigator, Washington University School of Medicine
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI for Non-invasive Evaluation of Brain Stress
- ClinicalTrials.gov ID
- NCT01898650
- Acronym / sponsor ID
- 201208086
- Conditions
- Craniosynostosis
- Keywords
- craniosynostosis, sagittal synostosis, metopic synostosis, coronal synostosis, lambdoid synostosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 30 Jan 2013 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 12 Jul 2013 (estimated)
- Results
- Posted 1 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- individual participants will serve as their own controls by using affected and unaffected regions of the brain for paired analysis
| Arm | Type | Receives |
|---|---|---|
| craniofacial abnormalities | Experimental | Other: MR scanSubjects with craniosynostosis or other craniofacial abnormalities associated with ICP who will undergo an MR scan. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (2 listed)
- history of abnormalities known to affect brain topology or function
- implants (e.g. pacemakers) that might rule out use of MR scanning.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR scan | Other | craniofacial abnormalities |
Primary outcome
Blood Flow and Perfusion
Time frame: during the single MRI scan, approximately 30 - 45 minutes
To be measured with both oxygen extraction fraction and arterial spin labeling to measure blood flow.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Frontal Reconstruction Without Orbital Advancement for Moderate Metopic Craniosynostosis
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Comparing Conservative to Surgical Treatment of Trigonocephaly Craniofacial Surgery in Children With Trigonocephaly: an Observational Cohort Study on Clinical Outcomes, Psychosocial Wellbeing, and Costs
Metopic Synostosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamlesh Patel, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
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.