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Trial registered on ANZCTR
Registration number
ACTRN12624001079538
Ethics application status
Approved
Date submitted
14/08/2024
Date registered
6/09/2024
Date last updated
6/09/2024
Date data sharing statement initially provided
6/09/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
MRI informed computational model for non-invasive detection of brain pressure
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Scientific title
Magnetic Resonance Imaging (MRI) of Brain Motion as an Indicator of Raised Intracranial Pressure.
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Secondary ID [1]
312754
0
Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Idiopathic Intracranial Hypertension
334792
0
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Condition category
Condition code
Neurological
331353
331353
0
0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Lumbar Puncture: Performed by experienced anesthetist, recording opening and closing pressure with spinal manometry to achieve a closing pressure of 25cmH2O or lower. this is expected to take 30-40 minutes. The lumbar puncture will take place within half an hour of the first MRI scan
MRI: includes both standard and study specific sequences (amplified). This will be conducted twice, both before and 4 hours after the lumbar puncture. The MRI will be administered by an MRI technician and is expected to take 45 to 60 minutes for each scan. The scan will be reviewed by a radiologist. The sequences will include both standard and study specific sequences. The study sequences are:
1. 2D Phase Contrast MRI for CSF flow in the region of the cerebral aqueduct and C2 of the spine to ascertain flow rates and regurgitation fraction
2. 4D Blood Flow analyzed through tested Quantitative Velocity Tool (QVT ) software (4D flow analysis tool developed by associates of University of Auckland)
3. aMRI data (Balanced Steady-State Free Precession Cine MR Imaging - cine bSSFPC MRI of the brain, amplified to 40x) to qualitatively map and quantitatively determine displacement of the brain over a cardiac cycle, with priority on areas that experience CSF flow and major brain motion, e.g. the ventricles, brainstem and upper spine.
OCT Scanning: imaging of the intraocular portion of the optic nerve head will be acquired before and after lumbar puncture. This investigation is expected to take 10-15 minutes and will be administered by either an imaging technician or an ophthalmologist. It will be reviewed by an ophthalmologist. The OCT scan will occur twice, each time prior to the MRI scan.
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Intervention code [1]
329285
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Diagnosis / Prognosis
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
339108
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Brain movement over a cardiac cycle
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Assessment method [1]
339108
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All MRI components will be assessed as a composite primary outcome
1) 2D Phase Contrast MRI for CSF flow in the region of the cerebral aqueduct and C2 of the spine to ascertain flow rates and regurgitation fraction
2) 4D Blood Flow analysed through tested QVT software
3) aMRI data (Balanced Steady-State Free Precession Cine MR Imaging - cine bSSFPC MRI of the brain, amplified to 40x) to qualitatively map and quantitatively determine displacement of the brain over a cardiac cycle, with priority on areas that experience CSF flow and major brain motion, e.g. the ventricles, brainstem and upper spine.
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Timepoint [1]
339108
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Baseline (pre-lumbar puncture) and 4-6 hours after lumbar puncture
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Secondary outcome [1]
438596
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Optic nerve sheath movement
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Assessment method [1]
438596
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Optic nerve sheath measurements via anatomical and aMRI data (Balanced Steady-State Free Precession Cine MR Imaging - cine bSSFPC MRI of the optic nerve, amplified to 40x) over the cardiac cycle.
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Timepoint [1]
438596
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Baseline ( pre-lumbar puncture) and 4-6 hours after the lumbar puncture
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Eligibility
Key inclusion criteria
• Adult subject 16 years or older
• Suspected or confirmed diagnosis of IIH by consultant ophthalmologist or neurologist.
• Subject willing and able to consent.
• Documented medical history and required information available for data collection.
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Minimum age
16
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Standard contraindications to MR imaging or to gadolinium-based contrast agents.
• History of lumbar spinal pathology or other vertebral pathology.
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
23/08/2024
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Date of last participant enrolment
Anticipated
29/08/2025
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Actual
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Date of last data collection
Anticipated
31/10/2025
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Actual
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Sample size
Target
60
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Accrual to date
1
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Final
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Recruitment outside Australia
Country [1]
26509
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New Zealand
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State/province [1]
26509
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Funding & Sponsors
Funding source category [1]
317184
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Government body
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Name [1]
317184
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Health research Council of New Zealand
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Address [1]
317184
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Country [1]
317184
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New Zealand
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Funding source category [2]
317185
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Charities/Societies/Foundations
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Name [2]
317185
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Royal Society of New Zealand via the Marsden Fund
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Address [2]
317185
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Country [2]
317185
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New Zealand
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Primary sponsor type
Charities/Societies/Foundations
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Name
Matai Medical Research Institute
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Address
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Country
New Zealand
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Secondary sponsor category [1]
319453
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University
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Name [1]
319453
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University of Auckland
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Address [1]
319453
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Country [1]
319453
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315928
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Northern B Health and Disability Ethics Committee
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Ethics committee address [1]
315928
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https://ethics.health.govt.nz/about/northern-b-health-and-disability-ethics-committee/
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Ethics committee country [1]
315928
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New Zealand
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Date submitted for ethics approval [1]
315928
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12/07/2024
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Approval date [1]
315928
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22/07/2024
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Ethics approval number [1]
315928
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Summary
Brief summary
The recent advent of amplified MRI has resulted in improvements in our ability to rapidly observe and inspect cardiac driven brain motions. aMRI amplifies the microscopic motion that occurs in the brain during a heartbeat. To test this theory, in this preliminary study, we apply aMRI pre- and post-lumbar puncture in IIH to explore whether the brain motion patterns are altered. If such cardiac-linked brain motion can be detected, this has the potential to allow for the non-invasive measurement of ICP. The central hypothesis posits that brain motion will be predictably and proportionally altered by changes in the level of ICP. The underlying rationale is that this motion is strongly determined by brain compliance and its perfusion, which is in turn strongly affected by the overall pressure within the cranium surrounding it (i.e. ICP).
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
136250
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A/Prof Samantha Holdsworth
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Address
136250
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Matai Medical Research Institute, 466 Childers Road Gisborne 1040 New Zealand
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Country
136250
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New Zealand
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Phone
136250
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+64 21834164
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Fax
136250
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Email
136250
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[email protected]
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Contact person for public queries
Name
136251
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Jet Wright
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Address
136251
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Matai Medical Research Institute, 466 Childers Road Gisborne 1040 New Zealand
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Country
136251
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New Zealand
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Phone
136251
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+64 273514296
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Fax
136251
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Email
136251
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[email protected]
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Contact person for scientific queries
Name
136252
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Samantha Holdsworth
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Address
136252
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Matai Medical Research Institute, 466 Childers Road Gisborne 1040 New Zealand
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Country
136252
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New Zealand
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Phone
136252
0
+64 21834164
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Fax
136252
0
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Email
136252
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
All de-identified data individual data
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When will data be available (start and end dates)?
Immediately following publication, end date is currently not determined
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Available to whom?
Researchers with sound proposal reviewed by the principal investigator
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Available for what types of analyses?
IPD for searcher related to IIH or aMRI
IPD for metanalysis
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How or where can data be obtained?
Contact the Principal investigator A/Prof Samantha Holdsworth at
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
24090
Ethical approval
388298-(Uploaded-14-08-2024-08-43-05)-Final Approval Letter.pdf
24091
Informed consent form
388298-(Uploaded-14-08-2024-08-43-40)-HITH PIS CF clean July 2024.docx
24139
Study protocol
388298-(Uploaded-29-08-2024-09-52-04)-HITH Protocol July 2024 clean.docx
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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