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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) (BQ5)

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ClinicalTrials.gov Identifier: NCT05044507
Recruitment Status : Recruiting
First Posted : September 14, 2021
Last Update Posted : January 18, 2023
Sponsor:
Information provided by (Responsible Party):
BrainQ Technologies Ltd.

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Ischemic Stroke Device: BQ 2.0 Not Applicable

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:

  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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: subjects will be assigned (1:1 allocation ratio) to either active or sham study intervention using BQ 2.0
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:

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.

Primary Purpose: Supportive Care
Official Title: The Efficacy of a Frequency-tuned Electromagnetic Field Treatment in Facilitating the Recovery of Subacute Ischemic Stroke Patients - a Pivotal Study (THE "EMAGINE" STUDY)
Actual Study Start Date : December 4, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

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.
Device: BQ 2.0
frequency and intensity parameters will be set to zero so that no stimulation is delivered
Other Name: BQ 2.0 sham stimulation group

Device: 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 Name: BQ 2.0 active stimulation group

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.
Device: BQ 2.0
frequency and intensity parameters will be set to zero so that no stimulation is delivered
Other Name: BQ 2.0 sham stimulation group

Device: 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 Name: BQ 2.0 active stimulation group




Primary Outcome Measures :
  1. 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 ]
    Mean change in mRS score from baseline (post-stroke day 4-21) to 90 days post stroke (90 ±15 days post-stroke)


Secondary Outcome Measures :
  1. 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 ]
    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

  2. 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) ]
    Secondary Endpoint: to show that the BQ therapy is effective in reducing upper limb impairment, and improving upper limb functionality

  3. 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 ) ]
    Secondary Endpoint: To show the BQ therapy is effective in reducing lower limb imperement

  4. 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 ) ]
    Secondary Endpoint: to show that the BQ therapy is effective in reducing upper limb impairment, and improving upper limb functionality

  5. 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 ) ]
    Secondary Endpoint: to show that the BQ therapy is effective in reducing upper limb impairment, and improving upper limb functionality

  6. 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 ) ]
    Secondary Endpoint: To show that the BQ therapy is effective in improving health-related quality of life (HRQoL)


Other Outcome Measures:
  1. 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 ) ]
    Safety: To characterize the safety profile of the BQ therapy and to show that the BQ 2.0 performs reliably.

  2. Change in Montreal Cognitive Assessment (global cognitive function) [ Time Frame: will be assessed at 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.

  3. Change in Patient Health Questionnaire-8 (depression) [ Time Frame: will be assessed on 90 Day FU visit ]
    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.

  4. 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 ]
    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.

  5. 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 ]
    Tertiary/Exploratory: To characterize the long-term effect at 6 months post-stroke of the BQ therapy effect on upper limb functionality

  6. 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 ]
    Tertiary/Exploratory: To characterize the long-term effect at 6 months post-stroke of the BQ therapy effect on upper limb functionality

  7. 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 ) ]
    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).

  8. 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 ]
    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.

  9. adherence to treatment as measured by the Qompass [ Time Frame: Will be assessed upon data base lock ]
    To explore the relationship between adherence to treatment as measured by the Qompass



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. mRS score of 3 or 4.
  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:

  1. 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.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05044507


Contacts
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Contact: Assaf Lifshitz 972 54 4586787 assaf@brainqtech.com

Locations
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United States, California
Ronald Reagan UCLA Medical Center & California Rehabilitation Institute Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Gilda Avila       GAvila@mednet.ucla.edu   
Principal Investigator: Mersedeh Bahr Hosseini, MD         
Sub-Investigator: Michael Su, MD         
United States, District of Columbia
MedStar National Rehabililtaion Hospital, Recruiting
Washington, District of Columbia, United States, 20010
Contact: Kathaleen Brady       Kathaleen.P.Brady@medstar.net   
Principal Investigator: Richard Zorowitz, MD         
United States, Florida
Brooks Rehabilitation Hospital - University Campus Recruiting
Jacksonville, Florida, United States, 32216
Contact: Hannah, MS, ACSM-EP       Hannah.Snyder@Brooksrehab.org   
Principal Investigator: Emily Fox         
The Miami Project to Cure Paralysis Not yet recruiting
Miami, Florida, United States, 33136
Contact: Iszet Campo-Bustillo    305-243-8018    icampo@med.miami.edu   
Principal Investigator: Ning Cao, MD         
United States, Illinois
Shirley Ryan Abilitylab Recruiting
Chicago, Illinois, United States, 60611
Contact: Sara J Prokup, PT, DPT       sprokup@ricres.org   
Principal Investigator: Eliot Roth, MD         
United States, Kansas
KU Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Sasha Moors       smoores@kumc.edu   
Principal Investigator: Sandra Billinger, PT, PhD,FAHA         
United States, Massachusetts
Spaulding Rehabilitation Hospital Recruiting
Boston, Massachusetts, United States, 02129
Contact: Jenny Min       bq5@partners.org   
Principal Investigator: Randie Black-Schaffer, MD         
United States, New Jersey
JFK Johnson Rehabilitation Institute Recruiting
Edison, New Jersey, United States, 08820
Contact: Maria Belen Montealegre, MD    (732) 321-7000 ext 62853    maria.montealegre@hmhn.org   
Principal Investigator: Sara J Cuccurullo, MD         
Kessler Institute of Rehabilitation Recruiting
West Orange, New Jersey, United States, 07052
Contact: Ghaith Androwis, Ph.D.    973-324-3565    gandrowis@kesslerfoundation.org   
Principal Investigator: Steven Kirshblum, MD         
United States, New York
NYP Brooklyn Methodist Hospital Outpatient Rehabilitation Recruiting
Brooklyn, New York, United States, 11215
Contact: Joy J Rutherford    718-780-7715    jor9147@nyp.org   
Principal Investigator: Joel Stein, MD         
United States, North Carolina
Atrium Health Carolinas Rehabilitation Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Tami Guerrier       Tami.Guerrier@atriumhealth.org   
Principal Investigator: Matthew Shall, MD         
United States, Pennsylvania
Moss Rehabilitation Research Institute Not yet recruiting
Elkins Park, Pennsylvania, United States, 19027
Contact: Grace Loscalzo         
Contact       CaoNing1@einstein.edu   
Principal Investigator: Ning Chao, MD         
United States, Texas
Baylor Scott & White Institute for Rehabilitation Not yet recruiting
Dallas, Texas, United States, 75246
Contact: Lacy Mcdonald       LACY.MCDONALD@BSWHEALTH.ORG   
Principal Investigator: Simon Driver, PhD         
TIRR Memorial Hermann Hospital Not yet recruiting
Houston, Texas, United States, 77030
Contact: Emily Stevens, OTR       Emily.A.Stevens@uth.tmc.edu   
Principal Investigator: Sean Savitz, MD         
Sponsors and Collaborators
BrainQ Technologies Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Jeffrey L Saver, MD Lead Coordinating PI
Principal Investigator: Pamela W Duncan, PhD Lead Coordinating PI
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Responsible Party: BrainQ Technologies Ltd.
ClinicalTrials.gov Identifier: NCT05044507    
Other Study ID Numbers: BQ5
First Posted: September 14, 2021    Key Record Dates
Last Update Posted: January 18, 2023
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by BrainQ Technologies Ltd.:
subacute
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Infarction
Necrosis