The Efficacy of a Frequency-tuned Electromagnetic Field Treatment in Facilitating the Recovery of Subacute Ischemic Stroke Patients - a Pivotal Study (the "EMAGINE 2.0" Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- BrainQ Technologies Ltd.
- Enrollment
- 122
- Locations
- 28
- Primary Endpoint
- Change from Baseline in Modified Rankin Scale
Study Overview
Brief Summary
This is a multicenter study that will be conducted at approximately 20 centers and up to 30 centers, if the sample size will be increased following interim assessment.
The Q Therapeutic System (BQ 3.0) 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.
The Q Therapeutic System (BQ 3.0) is indicated for adjunctive use in a clinical facility or home setting, in addition to standard-of-care therapies.
- In Stage 1 (starting 4-21 days after the index stroke event to day 90 post stroke), participants will be randomly assigned (1:1) to receive either active or the sham treatments, up to 5 times a week, and at least to a total of 45 treatments.
- In Stage 2 (day 90 to day 180 post stroke), participants in both the active and the control group will be allowed to continue to receive active treatments, up to 5 times per week.
- In stage 3 (day 180 to day 270 post stroke), participants will not receive any treatments and would be followed up until the final visit at day 270.
Each session will last approximately 60 minutes, with stimulation activated for up to 40 minutes, in conjunction with a home-based exercise program. Treatments may be administered in the hospital, in the clinic or in a home setting.
The study will enroll 100-122 adult subjects who will be randomly assigned (1:1 allocation ratio) to either active or sham study intervention using the BQ 3.0 system.
Detailed Description
The study intervention will be initiated 4-21 days after the index stroke event and will consist of 5 treatments per week until the primary endpoint follow-up visit, at day 90 (±15) after the onset of the index stroke. A minimum of 45 treatment sessions should be completed during this stage, with a potential of a maximum of 72 treatment sessions, depending on the start date of the first treatment and the timing of the 90-day follow-up visit. Though, participants and sites will be guided to conduct the 90 days follow-up visit as soon as possible after the 45th treatment session and within up to 7 days from the 45th treatment and after the window opening.
Each treatment session will last approximately 60 minutes and include 40 minutes of active or sham stimulation. Subjects in both groups will be asked to perform a home-based exercise program for the upper and the lower limb, concurrent with the study intervention.
Screening phase:
Prospective subjects, who are 3 to 21 days post-stroke, may be offered informed consent to participate in the study at either:
a participating inpatient or outpatient center, non-participating inpatient or outpatient center, in accordance with both the participating and the non-participating centers' policy, or home Consented subjects, who are 4 to 21 days post-stroke, will be screened for eligibility to participate in the treatment phase of the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
This is a double-blind study, Sponsor, 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 (except the unblinded randomizer). 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.
Eligibility Criteria
- Ages
- 22 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •mRS score of 3 or
- •FMA-UE score between 10-45 (inclusive) of impaired limb.
- •SAFE score >
- •Age 22 to 80 years of age (inclusive).
- •Diagnosed with an ischemic stroke, confirmed by CT4 or MRI5 imaging.
- •First ever ischemic stroke, or a recurring ischemic stroke6 occurring at least 3 months after the previous stroke (any stroke), without residual neurological impairment or disability before current stroke.
- •Four to 21 days from stroke onset (or last known well).
- •Pre-stroke mRS of
- •Able to sit with the investigational device for 40 consecutive minutes, in the opinion of the investigator or designee.
- •Can follow a 3-step command, such as "take the paper, fold it in half, and return it to me".
- •Willingness to participate in an exercise activity during study intervention sessions.
- •Availability of a relative or other caregiver able to assist in operating an application installed on a mobile device, including a video call, and assist the participant with the exercising program.
- •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.
Exclusion Criteria
- •Hemineglect impairment (NIHSS item 11, score >0).
- •Implanted active electronic or passive MR-incompatible devices.
- •Pre-existing major neurological condition (eg, Alzheimer's disease, Parkinson's disease, multiple sclerosis, traumatic brain injury, spinal cord injury) or pre-existing 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 any epileptic seizure in the last 5 years
- •Significant visual disturbances, pre-existing or resulting from the index stroke, 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 major psychiatric condition) or life expectancy of less than 12 months.
- •A known severe allergic reaction to acrylic-based adhesives.
- •Alcohol abuse and/or illicit drug abuse in the past 6 months, which is likely to influence ability to fully participate in the trial.
- •Participation in another trial that would conflict with the current study or clinical endpoint interference may occur.
- •Employee of the Sponsor.
Outcomes
Primary Outcomes
Change from Baseline in Modified Rankin Scale
Time Frame: 4 to 21 days following an ischemic stroke to 90-day post-stroke
Proportion of subjects achieving an excellent outcome defined as a Modified Rankin Scale (mRS) score of 0-1 at the 90-day post-stroke assessment, reflecting freedom from disability.
Secondary Outcomes
- Ordinal shift analysis of the mRS (trichotomized at 0-1, 2, 3-6) (Key Secondary Effectiveness Endpoint)(baseline to the 90-day post-stroke assessment)
- Change from Baseline in Modified Rankin Scale (Key Secondary Effectiveness Endpoint)(baseline (4-21 days post-stroke) to 90 days post-stroke)
- Proportion of subjects achieving functional independence (mRS score of 0-2) (Key Secondary Effectiveness Endpoint)(at the 90-day post-stroke assessment)
- Stroke Impact Scale Hand Domain (Lead Secondary Endpoint)(baseline (4 to 21 days following an ischemic stroke) to 90-day post-stroke)
- Stroke Impact Scale 16(baseline (4 to 21 days following an ischemic stroke) to 90-day post-stroke)
- 10-meter Walk Test(change from baseline to 90 days post-stroke)
- Box and Block Test(baseline (4 to 21 days following an ischemic stroke) to 90-day post-stroke)
- Evaluation of 5-level EQ-5D(At 90-days post-stroke)
- Fugl-Meyer Assessment for Upper Extremity (FMA-UE)(baseline (4 to 21 days following an ischemic stroke) to 90-day post-stroke)
- Nine-Hole Peg Test(change from baseline to 90-days post-stroke)
- The proportion of subjects within those in the active group who continued to receive treatments in Stage 2, achieving an excellent outcome (defined as a mRS of 0-1) at the 180-day post-stroke assessment.(at the 180-day post-stroke assessment)
- The proportion of patients within those in the active group who continued to receive treatments in Stage 2, who achieved an excellent outcome defined as a mRS score of 0-1 at the 90-day post-stroke assessment and had an mRS >1 at 180-day post-stroke(at 180 days post-stroke)
- The proportion of patients within those in the active group who continued to receive treatments in Stage 2, who achieved an excellent outcome defined as mRS score of 0-1 at the 180-day post-stroke assessment and had an mRS >1 at 270 days post-stroke.(at 270 days post-stroke)
- Ordinal shift analysis of the mRS (4 levels at 0, 1, 2, 3-6) from the 90-day post-stroke assessment to 180-day post-stroke assessment, within those in the active group who continued to receive treatments in Stage 2(from the 90-day post-stroke assessment to 180-day post-stroke assessment)
- The proportion of patients who improved by at least 1 level on the mRS from the 90-day post-stroke assessment to 180-day post-stroke assessment, within those in the active group who continued to receive treatments in Stage 2.(from the 90-day post-stroke assessment to 180-day post-stroke assessment)
- The proportion of subjects within those in the sham group who continued to receive treatments in Stage 2, achieving an excellent outcome (defined as a mRS of 0-1) at the 180-day post-stroke assessment, and had an mRS >1 at 90 days post-stroke.(from the 90-day assessment to the 180-day assessment)