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

Not Applicable

Recruiting

• Conditions: Stroke; Neurological - Other neurological disorders; Stroke - Haemorrhagic; Stroke - Ischaemic

• Registration Number: ACTRN12622001320741
• Lead Sponsor: Cyban Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-12
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[ 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 Measures

Name	Time	Method
The accuracy of the monitor will be assessed against the gold standards used to detect stroke CT and MRI brain scans [ 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. ]