BQ 2.0 is a wearable medical device that produces and delivers non-invasive, extremely-low–intensity and low-frequency, frequency-tuned electromagnetic fields in order to stimulate neuronal networks with the aim of reducing disability and promoting neurorecovery. In this study, BQ 2.0 is intended to reduce disability in adult patients with subacute ischemic stroke, with a moderate to severe disability which includes an upper extremity motor impairment. BQ 2.0 will be used for 9 weeks in conjunction with physical and occupational therapy (PT/OT), with treatment initiated in acute care hospital (ACH) or inpatient rehabilitation facilities (IRF) and then continued post-discharge in subjects’ homes under periodic remote supervision of a trained site study team member.
- Age 22 to 80 years of age (inclusive)
- Diagnosed with an ischemic stroke, confirmed by CT21 or MRI22 imaging
- Four to 14 days from stroke onset
- mRS score of 3 or 4
- FMA-UE score between 10-45 (inclusive) of impaired limb
- Able to sit with the investigational device for 40 consecutive minutes, in the opinion of
- the investigator or designee
- Can follow a 3-step command
- Willingness to participate in occupational/physical therapy activities during study
- intervention sessions.
- Availability of a relative or other caregiver able to assist during PT/OT treatment, and to
- operate an application installed on a mobile device, including a video call
BrainQ Technologies, Ltd.