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Brain Pulse Monitoring Study in patients with or at risk of developing stroke to provide earlier detection of stroke

A feasibility study in patients with or at risk of stroke of a brain pulse monitor for earlier detection and treatment of stoke:

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001320741
Acronym
BPM Study
Enrollment
36
Registered
2022-10-12
Start date
2023-02-20
Completion date
2026-02-11
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Cyban Pty Ltd
Lead SponsorCommercial sector/Industry

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

Exclusion criteria

Pre-existing major brain injury (sub-arachnoid haemorrhage is excluded from this criteria) Stroke symptoms present for more than 24 hours

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026