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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BQ 2.0 sham stimulation group | Sham Comparator | 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. |
|
| BQ 2.0 active stimulation group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BQ 2.0 | Device | frequency and intensity parameters will be set to zero so that no stimulation is delivered |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Serious procedure or device related adverse events & device deficiencies | Safety: To characterize the safety profile of the BQ therapy and to show that the BQ 2.0 performs reliably. | Through study completion, an average of 90 ± 15 days post-stroke (will be assessed on 90 Day FU visit ) |
| Change in Montreal Cognitive Assessment (global cognitive function) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey L Saver, MD | Lead Coordinating PI | Principal Investigator |
| Pamela W Duncan, PhD | Lead Coordinating PI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rancho Research Institute | Downey | California | 90242 | United States | ||
| Ronald Reagan UCLA Medical Center & California Rehabilitation Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41105410 | Derived | Saver JL, Duncan PW, Stein J, Cramer SC, Fox EJ, Zorowitz RD, Billinger SA, Eickmeyer SM, Kirshblum SC, Androwis GJ, Edwards J, Savitz SI, Koch S, Shall MB, Black-Schaffer RM, Bonato P, Cuccurullo SJ, Barcikowski J, Cao N, Bornstein NM; EMAGINE 1 Trial Investigators. Electromagnetic Stimulation to Reduce Disability After Ischemic Stroke: The EMAGINE Randomized Clinical Trial. JAMA Netw Open. 2025 Oct 1;8(10):e2537880. doi: 10.1001/jamanetworkopen.2025.37880. | |
| 37213907 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 20, 2022 | Feb 23, 2023 |
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subjects will be assigned (1:1 allocation ratio) to either active or sham study intervention using BQ 2.0
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This is a double-blind study, subjects and Investigators will be blinded to the device setting (Active/Sham). The study site team members receiving, storing, dispensing, preparing, and administering the study interventions will be blinded. Subjects' caregivers will also be blinded. There are no differences in the active and sham device appearance. Due to the non-invasive nature of the treatment, as well as the physical characteristic of the EMF, there is no noticeable difference between sessions conducted using an active or a sham device, facilitating full blinding of both subjects and Investigators.
An independent unblinded statistician (not the study statistician) will perform the assessments described. Only the unblinded statistician and members of the DSMB will be exposed to the interim report.
|
| BQ 2.0 | Device | 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 |
|
|
| 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 ) |
Tertiary/Exploratory: To show that the BQ therapy is effective in reducing cognitive impairment at 3 months post-stroke, when initiated 4 to 14 days following an ischemic stroke. |
| will be assessed at 90 Day FU visit |
| Change in Patient Health Questionnaire-8 (depression) | Tertiary/Exploratory: To show that the BQ therapy is effective in reducing depression at 3 months post-stroke, when initiated 4 to 14 days following an ischemic stroke. | will be assessed on 90 Day FU visit |
| Change in Academic Medical Center Linear Disability Scale (granular level of disability) at 90 days post-stroke. | Tertiary/Exploratory: To show that the BQ therapy is effective in reducing fine-grained level of disability at 3 months post-stroke, when initiated 4 to 14 days following an ischemic stroke. | will be assessed on 90 Day FU visit |
| Change from Baseline in Modified Rankin Scale (global disability) | Tertiary/Exploratory: To characterize the long-term effect at 6 months post-stroke of the BQ therapy effect on upper limb functionality | change from baseline (4-21 days post-stroke) to 180 days post-stroke. will be assessed at 6 month FU visit |
| Change from Baseline in Stroke Impact Scale Hand Domain (patient-reported hand function) | Tertiary/Exploratory: To characterize the long-term effect at 6 months post-stroke of the BQ therapy effect on upper limb functionality | change from baseline (4-21 days post-stroke) to 180 days post-stroke will be assessed at 6 month FU visit |
| Change from Baseline in 5-level EQ-5D (health-related quality of life) at 180 days post-stroke. | Tertiary/Exploratory:To characterize the long-term effect at 6 months post-stroke of the BQ therapy effect on health-related quality of life (HRQoL). | change from baseline (4-21 days post-stroke) to 180 days post-stroke (will be assessed at 6 month FU visit ) |
| Formal cost-effectiveness analysis over a lifetime horizon from the perspective of the United States healthcare system. | Tertiary/Exploratory: To formally evaluate the cost-effectiveness of the BQ therapy over a lifetime horizon from the perspective of the United States healthcare system. | Will be assessed at 90 day FU visit and 6 month FU visit |
| adherence to treatment as measured by the Qompass | To explore the relationship between adherence to treatment as measured by the Qompass | Will be assessed upon data base lock |
| Los Angeles |
| California |
| 90095 |
| United States |
| MedStar National Rehabililtaion Hospital, | Washington D.C. | District of Columbia | 20010 | United States |
| Brooks Rehabilitation Hospital - University Campus | Jacksonville | Florida | 32216 | United States |
| The Miami Project to Cure Paralysis | Miami | Florida | 33136 | United States |
| Shirley Ryan Abilitylab | Chicago | Illinois | 60611 | United States |
| KU Medical Center | Kansas City | Kansas | 66160 | United States |
| Spaulding Rehabilitation Hospital | Boston | Massachusetts | 02129 | United States |
| JFK Johnson Rehabilitation Institute | Edison | New Jersey | 08820 | United States |
| Kessler Institute of Rehabilitation | West Orange | New Jersey | 07052 | United States |
| NYP Brooklyn Methodist Hospital Outpatient Rehabilitation | Brooklyn | New York | 11215 | United States |
| Atrium Health Carolinas Rehabilitation | Charlotte | North Carolina | 28203 | United States |
| Moss Rehabilitation Research Institute | Elkins Park | Pennsylvania | 19027 | United States |
| Baylor Scott & White Institute for Rehabilitation | Dallas | Texas | 75246 | United States |
| TIRR Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
| Derived |
| Saver JL, Duncan PW, Stein J, Cramer SC, Eng JJ, Lifshitz A, Hochberg A, Bornstein NM. EMAGINE-Study protocol of a randomized controlled trial for determining the efficacy of a frequency tuned electromagnetic field treatment in facilitating recovery within the subacute phase following ischemic stroke. Front Neurol. 2023 May 5;14:1148074. doi: 10.3389/fneur.2023.1148074. eCollection 2023. |
| Prot_001.pdf |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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