Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000112763
Ethics application status
Approved
Date submitted
9/12/2021
Date registered
24/01/2022
Date last updated
16/12/2022
Date data sharing statement initially provided
24/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety, feasibility and acceptability of a wearable electroencephalography (EEG) device
Scientific title
Clinical safety study to assess the safety, feasibility and acceptability of a long-term, continuous monitoring, wearable electroencephalography (EEG) device in ischemic stroke patients
Secondary ID [1] 306135 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischemic Stroke 324631 0
Condition category
Condition code
Stroke 322075 322075 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will wear an EEG device for 9 hours while they are in the stroke ward at Westmead Hospital. The devices uses EEG and electrocardiography (ECG) sensors for safe, non-invasive,
passive monitoring of brain and heart activity, respectively. The device contains:
Fabric, elastic headband (basic head wraps, Scunci).
3D printed Flexible thermoplastic polyurethane (TPU) band to house scalp electrodes.
Four EEG leads terminating in ECG snap electrodes (TDE-205XX flat snap lead wire, Florida Research Institute), placed across the scalp (Fp1, Fp2, F7, F8).
Two ECG leads terminating in ECG snap electrodes (EMG/ECG snap electrode cable, OpenBCI), placed on the chest (LA, RA).
Four neonatal ECG sticker electrodes (disposable electrode PG10C, FIAB) placed across the scalp (Fp1, Fp2, F7, F8).
Two adult ECG sticker electrodes (red dot monitoring electrode with abrader, 3M) placed on the chest (LA, RA).
Two ground/reference ear clip electrodes (ear clip electrode, OpenBCI).
OpenBCI Cyton biosensing board (8-channels) (OpenBCI).
Lithium battery (3.7v, 500mA) (Shenzhen Pkcell Battery Co. Ltd).
Lithium battery charging board (USB LiIon/LiPoly charger - v1.2, Adafruit Industries).
3D printed A polylactic acid (PLA) enclosure to house Cyton board, battery and charging unit.

The device will wirelessly transmit data to an OpenBCI radiofrequency USB Dongle (via
Bluetooth) plugged into to a nearby laptop/computer running the OpenBCI GUI
software. Participants will be free to move around and receive clinical care as normal during the study. However, they must remain in the stroke ward.

A trained nurse will fit the EEG device to participants heads. Data captured by the device will be screened for continuity throughout the duration of the study. Verbal confirmation will indicate the end of the study and a nurse will remove the EEG device.
Intervention code [1] 322404 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329843 0
Device Safety
Will be assessed by the reporting of adverse events via the questionnaire. The questionnaire was designed specifically for this study.
Timepoint [1] 329843 0
1, 3, 6 and 9 hours after the EEG device was fitted and the recording was started.
Primary outcome [2] 330026 0
Device acceptability
Will be assessed via the questionnaire. Questions focusing on user experience, comfort and satisfaction. The questionnaire was designed specifically for this study.
Timepoint [2] 330026 0
1, 3, 6 and 9 hours after the device was fitted and the recording was started.
Primary outcome [3] 330027 0
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.
Timepoint [3] 330027 0
This will be assessed following the completion of the study.
Secondary outcome [1] 405347 0
Nil
Timepoint [1] 405347 0
Nil

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2022
Actual
15/03/2022
Date of last participant enrolment
Anticipated
23/06/2022
Actual
8/07/2022
Date of last data collection
Anticipated
30/06/2022
Actual
8/07/2022
Sample size
Target
20
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21304 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 36184 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 310345 0
University
Name [1] 310345 0
The University of Sydney
Country [1] 310345 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Faculty of Engineering, Darlington Campus, The University of Sydney, NSW 2006 Australia
Country
Australia
Secondary sponsor category [1] 311478 0
None
Name [1] 311478 0
Address [1] 311478 0
Country [1] 311478 0
Other collaborator category [1] 282087 0
Hospital
Name [1] 282087 0
Westmead Hospital
Address [1] 282087 0
Cnr Hawkesbury Road and, Darcy Rd, Westmead NSW 2145
Country [1] 282087 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309998 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 309998 0
Darcy Rd, Westmead NSW 2145
Ethics committee country [1] 309998 0
Australia
Date submitted for ethics approval [1] 309998 0
18/11/2021
Approval date [1] 309998 0
01/02/2022
Ethics approval number [1] 309998 0

Summary
Brief summary
Clinical safety study to assess the safety, feasibility and acceptability of a long-term, continuous monitoring, wearable electroencephalography (EEG) device in ischemic stroke patients. The device will be worn for 9 hours by 20 patients with acute ischemic stroke. Eligible participants will have already received treatment and will be in the stroke ward being monitored for at least 9 hours. Participants will be asked to complete a questionnaire at 1, 3, 6 and 9 hours to assess device comfort, acceptability and user experience. Safety will be assessed by the number of adverse events. Feasibility will be assessed as the number of hours of viable data as a percentage of the total recording time. The device will not interfere with standard care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116126 0
Dr Andrew Evans
Address 116126 0
Stroke Ward
Westmead Hospital
Cnr Hawkesbury Road and, Darcy Rd, Westmead NSW 2145
Country 116126 0
Australia
Phone 116126 0
+61 400949703
Fax 116126 0
Email 116126 0
[email protected]
Contact person for public queries
Name 116127 0
Samuel van Bohemen
Address 116127 0
School of Biomedical Engineering, Level 5, J03
Faculty of Engineering and IT
The University of Sydney
Darlington
NSW 2006
Country 116127 0
Australia
Phone 116127 0
+61 435045054
Fax 116127 0
Email 116127 0
[email protected]
Contact person for scientific queries
Name 116128 0
Samuel van Bohemen
Address 116128 0
School of Biomedical Engineering, Level 5, J03
Faculty of Engineering and IT
The University of Sydney
Darlington
NSW 2006
Country 116128 0
Australia
Phone 116128 0
+61 435045054
Fax 116128 0
Email 116128 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


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.