Trial Review

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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
Scientific title
Magnetic Resonance Imaging (MRI) of Brain Motion as an Indicator of Raised Intracranial Pressure.
Secondary ID [1] 312754 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Intracranial Hypertension 334792 0
Condition category
Condition code
Neurological 331353 331353 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 329285 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339108 0
Brain movement over a cardiac cycle
Timepoint [1] 339108 0
Baseline (pre-lumbar puncture) and 4-6 hours after lumbar puncture
Secondary outcome [1] 438596 0
Optic nerve sheath movement
Timepoint [1] 438596 0
Baseline ( pre-lumbar puncture) and 4-6 hours after the lumbar puncture

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.
Minimum age
16 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Standard contraindications to MR imaging or to gadolinium-based contrast agents.
• History of lumbar spinal pathology or other vertebral pathology.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
23/08/2024
Date of last participant enrolment
Anticipated
29/08/2025
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
60
Accrual to date
1
Final
Recruitment outside Australia
Country [1] 26509 0
New Zealand
State/province [1] 26509 0

Funding & Sponsors
Funding source category [1] 317184 0
Government body
Name [1] 317184 0
Health research Council of New Zealand
Country [1] 317184 0
New Zealand
Funding source category [2] 317185 0
Charities/Societies/Foundations
Name [2] 317185 0
Royal Society of New Zealand via the Marsden Fund
Country [2] 317185 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Matai Medical Research Institute
Address
Country
New Zealand
Secondary sponsor category [1] 319453 0
University
Name [1] 319453 0
University of Auckland
Address [1] 319453 0
Country [1] 319453 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315928 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 315928 0
Ethics committee country [1] 315928 0
New Zealand
Date submitted for ethics approval [1] 315928 0
12/07/2024
Approval date [1] 315928 0
22/07/2024
Ethics approval number [1] 315928 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136250 0
A/Prof Samantha Holdsworth
Address 136250 0
Matai Medical Research Institute, 466 Childers Road Gisborne 1040 New Zealand
Country 136250 0
New Zealand
Phone 136250 0
+64 21834164
Fax 136250 0
Email 136250 0
s.holdsworth@matai.org.nz
Contact person for public queries
Name 136251 0
Jet Wright
Address 136251 0
Matai Medical Research Institute, 466 Childers Road Gisborne 1040 New Zealand
Country 136251 0
New Zealand
Phone 136251 0
+64 273514296
Fax 136251 0
Email 136251 0
j.wright@matai.org.nz
Contact person for scientific queries
Name 136252 0
Samantha Holdsworth
Address 136252 0
Matai Medical Research Institute, 466 Childers Road Gisborne 1040 New Zealand
Country 136252 0
New Zealand
Phone 136252 0
+64 21834164
Fax 136252 0
Email 136252 0
s.holdsworth@matai.org.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified data individual data
When will data be available (start and end dates)?
Immediately following publication, end date is currently not determined
Available to whom?
Researchers with sound proposal reviewed by the principal investigator
Available for what types of analyses?
IPD for searcher related to IIH or aMRI
IPD for metanalysis
How or where can data be obtained?
Contact the Principal investigator A/Prof Samantha Holdsworth at s.holdsworth@matai.org.nz


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24090Ethical approval    388298-(Uploaded-14-08-2024-08-43-05)-Final Approval Letter.pdf
24091Informed consent form    388298-(Uploaded-14-08-2024-08-43-40)-HITH PIS CF clean July 2024.docx
24139Study 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.