Safety, feasibility and acceptability of a wearable electroencephalography (EEG) device

Not Applicable

Completed

• Conditions: Ischemic Stroke; Stroke - Ischaemic

• Registration Number: ACTRN12622000112763
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-24
• Study Completion: 2022-07-08
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Male and female patients with CT or MRI confirmed ischemic stroke.
18 years and older.
Patients have received appropriate stroke treatment and are now in the stroke ward for monitoring (for at least 9 hours) before being discharged

Exclusion Criteria

Haemorrhagic stroke, stroke mimic, transient ischemic attack, or no stroke.
Brain surgery or any intervention or condition that will prevent patient from wearing
a head device for 9 hours.
Patient is already being monitored using EEG equipment.
Patient has a history of epilepsy and/or seizures.
Younger than 18 years old.
Patient has brain or scalp implant.
Patient has a cognitive impairment that will make them more susceptible to forms
of discomfort or distress induced by wearing the device.
Patient is unable to complete the questionnaire with the help of a family member,
guardian, caregiver, or nurse.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Device Safety<br>Will be assessed by the reporting of adverse events via the questionnaire. The questionnaire was designed specifically for this study. <br>[1, 3, 6 and 9 hours after the EEG device was fitted and the recording was started.];Device acceptability<br>Will be assessed via the questionnaire. Questions focusing on user experience, comfort and satisfaction. The questionnaire was designed specifically for this study. [1, 3, 6 and 9 hours after the device was fitted and the recording was started.];Device feasibility Will be assessed as the number of hours of viable data as a percentage of the total recording time. This will be assessed for: Wirelessly streamed data. [This will be assessed following the completion of the study.]

Secondary Outcome Measures

Name	Time	Method
il[Nil]