The Efficacy of a Frequency-tuned Electromagnetic Field Treatment in Facilitating the Recovery of Subacute Ischemic Stroke Patients - a Pivotal Study (THE "EMAGINE" STUDY)
This is a multicenter study that will be conducted at approximately 20 centers. 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) and periodic supervision (either remote or in person) of a trained site study team member. Treatments may be administered in multiple settings (e.g. acute care hospital (ACH) or inpatient rehabilitation facilities (IRF), Skilled Nursing Facility (SNF), home or other outpatient setup). The study will enroll up to 150 adult subjects who will be randomly assigned (1:1 allocation ratio) to either active or sham study intervention using BQ 2.0.
- mRS score of 3 or 4.
- FMA-UE score between 10-45 (inclusive) of impaired limb.
- Age 22 to 85 years of age (inclusive).
- Diagnosed with an ischemic stroke, confirmed by CT or MRI imaging.
- 4 to 21 days from stroke onset (or last known well).
- Pre-stroke mRS of 0 or 1.
- Able to sit with the investigational device for 40 consecutive minutes.
- Can follow a 3-step command, such as "take the paper, fold it in half, and return it to me".
- 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 delivered via video call sessions during the study.
- If female, not pregnant (as confirmed by a urine or a blood test, or as determined by an official medical document) or breastfeeding and with no ability to become pregnant or on an acceptable method of contraception during the study
- Informed consent signed by subject (if competent) or legally authorized representative.
- Severe neglect impairment (NIHSS item 11 score = 2) or neglect that is severe enough to interfere with reasonable performance of study procedures. assessments or treatments.
- Implanted active electronic or passive MR-incompatible devices.
- Previous ischemic or hemorrhagic stroke within the 2 weeks before the index stroke.
- Pre-existing neurological condition (eg, Alzheimer's disease, Parkinson's disease, multiple sclerosis, traumatic brain injury, spinal cord injury) or physical limitation that would interfere significantly with the subject's participation in the study and/or confound neurological or functional evaluation.
- Active epilepsy or currently taking anti-epileptic medication (indicated for the treatment of a seizure disorder), or seizure in the last 5 years.
- Significant visual disturbances that cannot be corrected and that would interfere significantly with the subject's participation in the study and/or confound neurological or functional evaluation.
- Unstable serious illness/condition (eg, active cancer, severe heart failure, active psychiatric condition) or life expectancy of less than 6 12 months.
- A known severe allergic reaction to acrylic-based adhesives.
- Ongoing alcohol abuse and/or illicit drug use.
- Participation in another trial that would conflict with the current study or clinical endpoint interference may occur.
- Employee of the Sponsor.