The Efficacy of a Frequency-tuned Electromagnetic Field Treatment in Facilitating the Recovery of Subacute Ischemic Stroke Patients – a Pivotal Study

Overview

This is a multicenter study that will be conducted at up to 20 inpatient rehabilitation facilities (IRFs) in the United States. 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), with treatment initiated in inpatient rehabilitation facilities (IRF) and then continued post-discharge in subjects' homes under periodic remote supervision of a trained site study team member. The study will enroll up to 150 subjects who will be randomly assigned (1:1 allocation ratio) to either active or sham study intervention using BQ 2.0.

Full Title of Study: “The Efficacy of a Frequency-tuned Electromagnetic Field Treatment in Facilitating the Recovery of Subacute Ischemic Stroke Patients – a Pivotal Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: December 31, 2023

Detailed Description

The study intervention will be initiated 4-10 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 9 days post-stroke, will be consented to participate in the study at either: 1. a participating initial acute care hospital (ACH) 1-2 days prior to anticipated transfer to a participating IRF; or 2. within the first 1-3 week days after arrival to a participating IRF. Consented subjects, who are 4 to 10 days post-stroke, will be screened for eligibility to participate in the treatment phase of the study within the first 1-3 days after arrival to a participating IRF. 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 4-10 days after stroke onset and no later than 48 hours after randomization. Each session will last up to 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 perform trial-specified physical and occupational therapy activities during each session, in addition to their standard care rehabilitation therapies. Subjects will undergo a detailed interim outcome assessment on the 20th (±4) day of treatment and final detailed outcome assessment on the 90th (±15) day after the onset of the index stroke.

Interventions

  • Device: BQ 2.0
    • frequency and intensity parameters will be set to zero so that no stimulation is delivered
  • 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

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Primary Endpoint: reducing global disability
    • Time Frame: change from baseline (4-10 days post stroke) to 90 days post stroke
    • Modified Rankin Scale change from baseline (4-10 days post stroke) to 90 days post stroke

Secondary Measures

  • Secondary Endpoint: reducing upper limb imperement
    • Time Frame: change from baseline (4-10 days post stroke) to 90 days post stroke
    • The secondary efficacy endpoints will be analyzed in stepwise gatekeeper manner to control for multiplicity. The hierarchical order of analysis will be in the following order: 1. Lead secondary endpoint: Fugl-Meyer Assessment for Upper Extremity (upper limb function) – change from baseline (4-10 days post-stroke) to 90 days post-stroke.
  • Secondary Endpoint: reducing upper limb imperement
    • Time Frame: change from baseline (4-10 days post stroke) to 90 days post stroke
    • 2. Box and Block Test (fine hand function) – change from baseline (4-10 days post-stroke) to 90 days post-stroke.
  • Secondary Endpoint: reducing upper limb imperement
    • Time Frame: change from baseline (4-10 days post stroke) to 90 days post stroke
    • 3. SIS Hand Domain (patient-reported hand function) – change from baseline (4-10 days post-stroke) to 90 days post-stroke.
  • Secondary Endpoint: reducing upper limb imperement
    • Time Frame: change from baseline (4-10 days post stroke) to 90 days post stroke
    • 4. SIS-16 (patient-reported physical functional limitation) – change from baseline (4-10 days post-stroke) to 90 days post-stroke.
  • Secondary Endpoint: reducing upper limb imperement
    • Time Frame: change from baseline (4-10 days post stroke) to 90 days post stroke
    • 5. EQ-5D-5L (health-related quality of life) at 90 days post-stroke.
  • Secondary Endpoint: reducing lower limb impairment
    • Time Frame: Change from baseline (4-10 days post-stroke) to 90 days post-stroke.
    • 10 Meter Walk Test (gait speed) – change from baseline (4-10 days post-stroke) to 90 days post-stroke.

Participating in This Clinical Trial

Inclusion Criteria

1. mRS score of 3 or 4. 2. FMA-UE score between 10-45 (inclusive) of impaired limb. 3. Age 22 to 80 years of age (inclusive). 4. Diagnosed with an ischemic stroke, confirmed by CT or MRI imaging. 5. 3 to 9 days from stroke onset (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 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. 13. Subject is within the first 1-3 weekdays after arrival to a participating IRF. 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 in the 3 months 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, or seizure in the last 5 years. 6. Significant visual disturbances that cannot be corrected (eg, hemianopia, diplopia, severe nystagmus, blindness) 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, heart failure, active psychiatric condition) or life expectancy of less than 6 12 months. 8. Ongoing alcohol abuse and/or illicit drug use. 9. Participation in another trial that would conflict with the current study or clinical endpoint interference may occur. 10. Employee of the Sponsor. 11. Prisoner.

Gender Eligibility: All

Minimum Age: 22 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • BrainQ Technologies Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jeffrey L Saver, MD, Principal Investigator, Lead Coordinating PI
    • Pamela W Duncan, PhD, Principal Investigator, Lead Coordinating PI
  • Overall Contact(s)
    • Assaf Lifshitz, 972 54 4586787, assaf@brainqtech.com

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