Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001320741
Ethics application status
Approved
Date submitted
4/10/2022
Date registered
12/10/2022
Date last updated
28/09/2023
Date data sharing statement initially provided
12/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Brain Pulse Monitoring Study in patients with or at risk of developing stroke to provide earlier detection of stroke
Scientific title
A feasibility study in patients with or at risk of stroke of a brain pulse monitor for earlier detection and treatment of stoke:
Secondary ID [1] 308107 0
None
Universal Trial Number (UTN)
Trial acronym
BPM Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 327802 0
Condition category
Condition code
Neurological 324875 324875 0 0
Other neurological disorders
Stroke 324876 324876 0 0
Haemorrhagic
Stroke 324877 324877 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Brain Pulse Oximeter is a non-invasive monitor that uses light to detect brain oxygen levels and brain photoplethysmography (PPG) signals. This is a monitoring study that will assess a novel point of care monitor that detects stroke. The accuracy of this device to detect stroke will be compared with the current gold standard. Patients presenting with stroke will have the monitor placed on the head and monitored prior to and following acute treatment of stroke, whilst they remain in hospital for a maximum of 14 days. The monitoring will be undertaken by the research group which includes the stroke neurological service. The monitor's outputs will not be used to guide treatment.
Intervention code [1] 324555 0
Diagnosis / Prognosis
Comparator / control treatment
The brain pulse monitor will be compared against routinely used methods of brain monitoring. The primary assessment will be a comparison with CT and MRI scans which are used to detect stroke.
Control group
Active

Outcomes
Primary outcome [1] 332689 0
Feasibility is the primary outcome - this will be assessed by the proportion of patients in which a brain signal is obtained as assessed by the morphology of the pulse waveform that is consistent with a brain pattern.
Timepoint [1] 332689 0
This will be assessed prior to and following acute treatment of stroke. This initial period of monitoring will vary from 2 to 12 hours. Monitoring may continue intermittently for up to 4 hour periods each day throughout the hospital stay to assess recovery. The hospital stay typically is 7 days.
Secondary outcome [1] 414372 0
The accuracy of the monitor will be assessed against the gold standards used to detect stroke CT and MRI brain scans
Timepoint [1] 414372 0
This will be assessed prior to and following acute treatment of stroke. This initial period of monitoring will vary from 2 to 12 hours. Monitoring may continue intermittently for up to 4 hour periods each day throughout the hospital stay to assess recovery. The hospital stay typically is 7 days.

Eligibility
Key inclusion criteria
Presentation with symptoms and signs of stroke
Presentation with symptoms and signs of vasospasm following sub-arachnoid haemorrhage
Undergoing surgery with elevated risk of developing stroke
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pre-existing major brain injury (sub-arachnoid haemorrhage is excluded from this criteria)
Stroke symptoms present for more than 24 hours

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
Other
Other design features
A single group of patients with established stroke. The accuracy of the brain pulse monitor to detect stroke will be compared to the gold standard methods CT and MRI brain scans.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/12/2022
Actual
20/02/2023
Date of last participant enrolment
Anticipated
5/08/2024
Actual
Date of last data collection
Anticipated
12/08/2024
Actual
Sample size
Target
100
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23303 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 25601 0
East Grampians Health Service - Willaura campus - Willaura
Recruitment postcode(s) [1] 38676 0
3065 - Fitzroy
Recruitment postcode(s) [2] 41426 0
3379 - Willaura

Funding & Sponsors
Funding source category [1] 312363 0
Other
Name [1] 312363 0
MTP-IIGC LIMITED
Country [1] 312363 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cyban Pty Ltd
Address
Level 18, 1 Nicholson Street, East Melbourne VIC 3002 Australia
Country
Australia
Secondary sponsor category [1] 313926 0
None
Name [1] 313926 0
None
Address [1] 313926 0
Country [1] 313926 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311722 0
St Vincents Hospital Melbourne Australia
Ethics committee address [1] 311722 0
45 Victoria Pde Fitzroy, 3065, Victoria
Ethics committee country [1] 311722 0
Australia
Date submitted for ethics approval [1] 311722 0
18/10/2022
Approval date [1] 311722 0
24/01/2023
Ethics approval number [1] 311722 0

Summary
Brief summary
The brain pulse monitor is a new non-invasive method that uses light to monitor brain oxygen levels and blood flow.
The purpose of the study is to determine if the brain pulse monitor accurately detects falls in brain oxygen and blood flow associated with stroke. The study will enrol adult patients with or at risk of developing a stroke. The target group are patients presenting to hospital with stroke, patients with sub-arachnoid haemorrhage that develop vasospasm and patients undergoing surgeries associated with a risk of stroke, such as carotid and cardiac surgery. The major outcome is to assess the accuracy of the brain pulse monitor to detect reduced brain oxygen and blood flow changes associated with stroke.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122134 0
Dr Barry Dixon
Address 122134 0
Level 18, 1 Nicholson Street, East Melbourne
VIC 3002 Australia

Principle investigator work organisation St Vincents Hospital 41 Victoria Pde Fitzroy 3065
Country 122134 0
Australia
Phone 122134 0
+610439618815
Fax 122134 0
Email 122134 0
[email protected]
Contact person for public queries
Name 122135 0
Dr Barry Dixon
Address 122135 0
ICU St Vincents Hospital Melbourne 41 Victoria Pde Fitzroy 3065
Country 122135 0
Australia
Phone 122135 0
+61439618815
Fax 122135 0
Email 122135 0
[email protected]
Contact person for scientific queries
Name 122136 0
Dr Barry Dixon
Address 122136 0


Principle investigator work organisation St Vincents Hospital 41 Victoria Pde Fitzroy 3065
Country 122136 0
Australia
Phone 122136 0
+610439618815
Fax 122136 0
Email 122136 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Concerns regarding use of this data by other commercial entities


What supporting documents are/will be available?

No Supporting Document Provided



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.