None listed
Conditions
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.
Interventions
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 R
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.
Sponsors
The University of Sydney
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed