The Efficacy of a Frequency-tuned Electromagnetic Field Treatment in Facilitating the Recovery of Subacute Ischemic Stroke Patients - a Pivotal Study (THE "EMAGINE" STUDY)
NCT ID: NCT05044507
Last Updated: 2024-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2021-12-04
2024-01-16
Brief Summary
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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.
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Detailed Description
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Screening phase:
Prospective subjects, who are 3 to 21 days post-stroke, will be consented to participate in the study at either:
1. a participating initial acute care hospital (ACH), prior to anticipated transfer to a participating IRF, SNF, Outpatient or home setting or
2. 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
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.
Study Groups
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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.
BQ 2.0
frequency and intensity parameters will be set to zero so that no stimulation is delivered
BQ 2.0
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
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.
BQ 2.0
frequency and intensity parameters will be set to zero so that no stimulation is delivered
BQ 2.0
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
Interventions
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BQ 2.0
frequency and intensity parameters will be set to zero so that no stimulation is delivered
BQ 2.0
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. FMA-UE score between 10-45 (inclusive) of impaired limb.
3. Age 22 to 85 years of age (inclusive).
4. Diagnosed with an ischemic stroke, confirmed by CT or MRI imaging.
5. 4 to 21 days from stroke onset (or last known well).
6. Pre-stroke mRS of 0 or 1.
7. Able to sit with the investigational device for 40 consecutive minutes.
8. Can follow a 3-step command, such as "take the paper, fold it in half, and return it to me".
9. Willingness to participate in occupational/physical therapy activities during study intervention sessions.
10. Availability of a relative or other caregiver able to assist during PT/OT treatment delivered via video call sessions during the study.
11. 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
12. Informed consent signed by subject (if competent) or legally authorized representative.
Exclusion Criteria
2. Implanted active electronic or passive MR-incompatible devices.
3. Previous ischemic or hemorrhagic stroke within the 2 weeks before the index stroke.
4. 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.
5. Active epilepsy or currently taking anti-epileptic medication (indicated for the treatment of a seizure disorder), or seizure in the last 5 years.
6. 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.
7. Unstable serious illness/condition (eg, active cancer, severe heart failure, active psychiatric condition) or life expectancy of less than 6 12 months.
8. A known severe allergic reaction to acrylic-based adhesives.
9. Ongoing alcohol abuse and/or illicit drug use.
10. Participation in another trial that would conflict with the current study or clinical endpoint interference may occur.
11. Employee of the Sponsor.
12. Prisoner.
22 Years
80 Years
ALL
No
Sponsors
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BrainQ Technologies Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jeffrey L Saver, MD
Role: PRINCIPAL_INVESTIGATOR
Lead Coordinating PI
Pamela W Duncan, PhD
Role: PRINCIPAL_INVESTIGATOR
Lead Coordinating PI
Locations
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Rancho Research Institute
Downey, California, United States
Ronald Reagan UCLA Medical Center & California Rehabilitation Institute
Los Angeles, California, United States
MedStar National Rehabililtaion Hospital,
Washington D.C., District of Columbia, United States
Brooks Rehabilitation Hospital - University Campus
Jacksonville, Florida, United States
The Miami Project to Cure Paralysis
Miami, Florida, United States
Shirley Ryan Abilitylab
Chicago, Illinois, United States
KU Medical Center
Kansas City, Kansas, United States
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States
JFK Johnson Rehabilitation Institute
Edison, New Jersey, United States
Kessler Institute of Rehabilitation
West Orange, New Jersey, United States
NYP Brooklyn Methodist Hospital Outpatient Rehabilitation
Brooklyn, New York, United States
Atrium Health Carolinas Rehabilitation
Charlotte, North Carolina, United States
Moss Rehabilitation Research Institute
Elkins Park, Pennsylvania, United States
Baylor Scott & White Institute for Rehabilitation
Dallas, Texas, United States
TIRR Memorial Hermann Hospital
Houston, Texas, United States
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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BQ5
Identifier Type: -
Identifier Source: org_study_id
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