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Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05044507
Study type Interventional
Source BrainQ Technologies Ltd.
Contact Assaf Lifshitz
Phone 972 54 4586787
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date September 2021
Completion date March 31, 2024

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