The Efficacy of a Frequency-tuned Electromagnetic Field Treatment in Facilitating the Recovery of Subacute Ischemic Stroke Patients - a Pivotal Study (THE EMAGINE STUDY)

Study Overview
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Brief Summary
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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.

Detailed Description
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The study intervention will be initiated 4-21 days after the index stroke event and will consist of a total of 45 sessions over a period of 9 weeks (5 treatments per week). Each session will last 60 minutes during which 40 net minutes of active or sham study intervention using BQ 2.0 will be administered. Each study group will receive a standardized, pre-defined and evidence-based physical and occupational therapy regimen concurrent with the study intervention. Screening phase: Prospective subjects, who are 3 to 21 days post-stroke, will be consented to participate in the study at either: a participating initial acute care hospital (ACH), prior to anticipated transfer to a participating IRF, SNF, Outpatient or home setting or at a participating IRF, SNF, outpatient or home setting Consented subjects, who are 4 to 21 days post-stroke will be screened for eligibility to participate in the treatment phase of the study. Eligible subjects will be randomly assigned, at a 1:1 allocation ratio, to either the active or sham study intervention groups. Treatment and follow-up Randomized patients will proceed to the treatment phase of the study. Active or sham study intervention sessions using BQ 2.0 (active or sham therapy, respectively) will be conducted 5 times a week, starting 4-21 days after stroke onset and no later than 2 days after randomization. Each session will last 60 minutes, with active or sham field being turned on for up to 40 minutes. The only difference between the BQ 2.0 active stimulation and sham therapy is that the sham device does not generate electromagnetic fields during treatment. Subjects in both the active intervention group (BQ 2.0 group) and sham group will be asked to perform device guided physical and occupational therapy activities during each session. Participation in the study will not replace any of usual care patient should recieve. Subjects will undergo a detailed interim outcome assessment on the 20th (±4) day of treatment and a detailed primary endpoint outcome assessment on the 90th (±15) day after the onset of the index stroke. In addition, a focused, long-term outcome assessment on the 180th (±15) day after the onset of the index stroke will be performed.

Official Title
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The Efficacy of a Frequency-tuned Electromagnetic Field Treatment in Facilitating the Recovery of Subacute Ischemic Stroke Patients - a Pivotal Study (THE EMAGINE STUDY)

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Device: BQ 2.0
* Device: BQ 2.0


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. Prisoner.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: subjects will be assigned (1:1 allocation ratio) to either active or sham study intervention using BQ 2.0
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: BQ 2.0 sham stimulation group<br>45 sessions over a period of 9 weeks (5 treatments per week) of sham study intervention with BQ 2.0 including a standardized, pre-defined and evidence-based physical and occupational therapy regimen concurrent with the study intervention. | Device: BQ 2.0<br>* frequency and intensity parameters will be set to zero so that no stimulation is delivered<br>* Other names: BQ 2.0 sham stimulation group;Device: BQ 2.0<br>* The BQ 2.0 is a medical device that produces and delivers non-invasive, extremely low intensity and frequency (1-100 Hz.; up to 1 G), frequency tuned electromagnetic fields in order to stimulate neuronal networks with the aim of reducing disability and promoting neurorecovery<br>* Other names: BQ 2.0 active stimulation group;|
| Active Comparator: BQ 2.0 active stimulation group<br>45 sessions over a period of 9 weeks (5 treatments per week) of active study intervention with BQ 2.0 including a standardized, pre-defined and evidence-based physical and occupational therapy regimen concurrent with the study intervention. | Device: BQ 2.0<br>* frequency and intensity parameters will be set to zero so that no stimulation is delivered<br>* Other names: BQ 2.0 sham stimulation group;Device: BQ 2.0<br>* The BQ 2.0 is a medical device that produces and delivers non-invasive, extremely low intensity and frequency (1-100 Hz.; up to 1 G), frequency tuned electromagnetic fields in order to stimulate neuronal networks with the aim of reducing disability and promoting neurorecovery<br>* Other names: BQ 2.0 active stimulation group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Modified Rankin Scale | Mean change in mRS score from baseline (post-stroke day 4-21) to 90 days post stroke (90 ±15 days post-stroke) | change from baseline (4-21 days post stroke) to 90 days post stroke. mRS will be assessed at 90 Day FU visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Fugl-Meyer Assessment for Upper Extremity (upper limb function) | Lead secondary endpoint: Fugl-Meyer Assessment for Upper Extremity (upper limb function) - to show that the BQ therapy is effective in reducing upper limb impairment, and improving upper limb functionality | change from baseline (4-21 days post stroke) to 90 days post stroke. FMA-EU will be assessed at 90 Day FU visit | 
| Change from Baseline in Box and Block Test (fine hand function) | Secondary Endpoint: to show that the BQ therapy is effective in reducing upper limb impairment, and improving upper limb functionality | change from baseline (4-21 days post stroke) to 90 days post stroke (will be assessed at 90 Day FU visit) | 
| Change from Baseline in 10 Meter Walk Test (gait speed) | Secondary Endpoint: To show the BQ therapy is effective in reducing lower limb imperement | change from baseline (4-21 days post stroke) to 90 days post stroke. (will be assessed at 90 Day FU visit ) | 
| Change from baseline in Stroke Impact Scale Hand Domain (patient-reported hand function) | Secondary Endpoint: to show that the BQ therapy is effective in reducing upper limb impairment, and improving upper limb functionality | change from baseline (4-21 days post stroke) to 90 days post stroke (will be assessed at 90 Day FU visit ) | 
| Change from baseline in Stroke Impact Scale 16 (patient-reported physical functional limitation) | Secondary Endpoint: to show that the BQ therapy is effective in reducing upper limb impairment, and improving upper limb functionality | change from baseline (4-21 days post stroke) to 90 days post stroke (will be assessed on 90 Day FU visit ) | 
| Change from baseline in 5-level EQ-5D (health-related quality of life) | Secondary Endpoint: To show that the BQ therapy is effective in improving health-related quality of life (HRQoL) | Change from baseline (4-21 days post-stroke) to 90 days post-stroke (will be assessed on 90 Day FU visit ) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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subacute