- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05044507
The Efficacy of a Frequency-tuned Electromagnetic Field Treatment in Facilitating the Recovery of Subacute Ischemic Stroke Patients - a Pivotal Study (THE "EMAGINE" STUDY) (BQ5)
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.
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Assaf Lifshitz
- Phone Number: 972 54 4586787
- Email: assaf@brainqtech.com
Study Locations
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California
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Downey, California, United States, 90242
- Rancho Research Institute
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Los Angeles, California, United States, 90095
- Ronald Reagan UCLA Medical Center & California Rehabilitation Institute
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District of Columbia
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Washington, District of Columbia, United States, 20010
- MedStar National Rehabililtaion Hospital,
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Florida
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Jacksonville, Florida, United States, 32216
- Brooks Rehabilitation Hospital - University Campus
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Miami, Florida, United States, 33136
- The Miami Project to Cure Paralysis
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Illinois
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Chicago, Illinois, United States, 60611
- Shirley Ryan AbilityLab
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Kansas
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Kansas City, Kansas, United States, 66160
- KU Medical Center
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Massachusetts
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Boston, Massachusetts, United States, 02129
- Spaulding Rehabilitation Hospital
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New Jersey
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Edison, New Jersey, United States, 08820
- JFK Johnson Rehabilitation Institute
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West Orange, New Jersey, United States, 07052
- Kessler Institute of Rehabilitation
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New York
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Brooklyn, New York, United States, 11215
- NYP Brooklyn Methodist Hospital Outpatient Rehabilitation
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North Carolina
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Charlotte, North Carolina, United States, 28203
- Atrium Health Carolinas Rehabilitation
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Pennsylvania
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Elkins Park, Pennsylvania, United States, 19027
- Moss Rehabilitation Research Institute
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Texas
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Dallas, Texas, United States, 75246
- Baylor Scott & White Institute for Rehabilitation
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Houston, Texas, United States, 77030
- TIRR Memorial Hermann Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: BQ 2.0 sham stimulation group
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.
|
frequency and intensity parameters will be set to zero so that no stimulation is delivered
Other Names:
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
Other Names:
|
Active Comparator: BQ 2.0 active stimulation group
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.
|
frequency and intensity parameters will be set to zero so that no stimulation is delivered
Other Names:
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Modified Rankin Scale
Time Frame: change from baseline (4-21 days post stroke) to 90 days post stroke. mRS will be assessed at 90 Day FU visit
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Mean change in mRS score from baseline (post-stroke day 4-21) to 90 days post stroke (90 ±15 days post-stroke)
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change from baseline (4-21 days post stroke) to 90 days post stroke. mRS will be assessed at 90 Day FU visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Fugl-Meyer Assessment for Upper Extremity (upper limb function)
Time Frame: change from baseline (4-21 days post stroke) to 90 days post stroke. FMA-EU will be assessed at 90 Day FU visit
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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
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change from baseline (4-21 days post stroke) to 90 days post stroke. FMA-EU will be assessed at 90 Day FU visit
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Change from Baseline in Box and Block Test (fine hand function)
Time Frame: change from baseline (4-21 days post stroke) to 90 days post stroke (will be assessed at 90 Day FU visit)
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Secondary Endpoint: to show that the BQ therapy is effective in reducing upper limb impairment, and improving upper limb functionality
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change from baseline (4-21 days post stroke) to 90 days post stroke (will be assessed at 90 Day FU visit)
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Change from Baseline in 10 Meter Walk Test (gait speed)
Time Frame: change from baseline (4-21 days post stroke) to 90 days post stroke. (will be assessed at 90 Day FU visit )
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Secondary Endpoint: To show the BQ therapy is effective in reducing lower limb imperement
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change from baseline (4-21 days post stroke) to 90 days post stroke. (will be assessed at 90 Day FU visit )
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Change from baseline in Stroke Impact Scale Hand Domain (patient-reported hand function)
Time Frame: change from baseline (4-21 days post stroke) to 90 days post stroke (will be assessed at 90 Day FU visit )
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Secondary Endpoint: to show that the BQ therapy is effective in reducing upper limb impairment, and improving upper limb functionality
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change from baseline (4-21 days post stroke) to 90 days post stroke (will be assessed at 90 Day FU visit )
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Change from baseline in Stroke Impact Scale 16 (patient-reported physical functional limitation)
Time Frame: change from baseline (4-21 days post stroke) to 90 days post stroke (will be assessed on 90 Day FU visit )
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Secondary Endpoint: to show that the BQ therapy is effective in reducing upper limb impairment, and improving upper limb functionality
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change from baseline (4-21 days post stroke) to 90 days post stroke (will be assessed on 90 Day FU visit )
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Change from baseline in 5-level EQ-5D (health-related quality of life)
Time Frame: Change from baseline (4-21 days post-stroke) to 90 days post-stroke (will be assessed on 90 Day FU visit )
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Secondary Endpoint: To show that the BQ therapy is effective in improving health-related quality of life (HRQoL)
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Change from baseline (4-21 days post-stroke) to 90 days post-stroke (will be assessed on 90 Day FU visit )
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serious procedure or device related adverse events & device deficiencies
Time Frame: Through study completion, an average of 90 ± 15 days post-stroke (will be assessed on 90 Day FU visit )
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Safety: To characterize the safety profile of the BQ therapy and to show that the BQ 2.0 performs reliably.
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Through study completion, an average of 90 ± 15 days post-stroke (will be assessed on 90 Day FU visit )
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Change in Montreal Cognitive Assessment (global cognitive function)
Time Frame: will be assessed at 90 Day FU visit
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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.
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will be assessed at 90 Day FU visit
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Change in Patient Health Questionnaire-8 (depression)
Time Frame: will be assessed on 90 Day FU visit
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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.
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will be assessed on 90 Day FU visit
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Change in Academic Medical Center Linear Disability Scale (granular level of disability) at 90 days post-stroke.
Time Frame: will be assessed on 90 Day FU visit
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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.
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will be assessed on 90 Day FU visit
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Change from Baseline in Modified Rankin Scale (global disability)
Time Frame: change from baseline (4-21 days post-stroke) to 180 days post-stroke. will be assessed at 6 month FU visit
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Tertiary/Exploratory: To characterize the long-term effect at 6 months post-stroke of the BQ therapy effect on upper limb functionality
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change from baseline (4-21 days post-stroke) to 180 days post-stroke. will be assessed at 6 month FU visit
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Change from Baseline in Stroke Impact Scale Hand Domain (patient-reported hand function)
Time Frame: change from baseline (4-21 days post-stroke) to 180 days post-stroke will be assessed at 6 month FU visit
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Tertiary/Exploratory: To characterize the long-term effect at 6 months post-stroke of the BQ therapy effect on upper limb functionality
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change from baseline (4-21 days post-stroke) to 180 days post-stroke will be assessed at 6 month FU visit
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Change from Baseline in 5-level EQ-5D (health-related quality of life) at 180 days post-stroke.
Time Frame: change from baseline (4-21 days post-stroke) to 180 days post-stroke (will be assessed at 6 month FU visit )
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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).
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change from baseline (4-21 days post-stroke) to 180 days post-stroke (will be assessed at 6 month FU visit )
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Formal cost-effectiveness analysis over a lifetime horizon from the perspective of the United States healthcare system.
Time Frame: Will be assessed at 90 day FU visit and 6 month FU visit
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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.
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Will be assessed at 90 day FU visit and 6 month FU visit
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adherence to treatment as measured by the Qompass
Time Frame: Will be assessed upon data base lock
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To explore the relationship between adherence to treatment as measured by the Qompass
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Will be assessed upon data base lock
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jeffrey L Saver, MD, Lead Coordinating PI
- Principal Investigator: Pamela W Duncan, PhD, Lead Coordinating PI
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BQ5
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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