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 …
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.
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Eligibility Criteria
Inclusion Criteria:
1. mRS score of 3 or 4.
2. FMA-UE score between 10-45 (inclusive) of impaired limb.
3. SAFE score \>0.
4. Age 22 to 80 years of age (inclusive).
5. Diagnosed with an ischemic stroke, confirmed by CT4 or MRI5 imaging.
6. First ever ischemic stroke, or a recurring ischemic stroke6…
Inclusion Criteria:
1. mRS score of 3 or 4.
2. FMA-UE score between 10-45 (inclusive) of impaired limb.
3. SAFE score \>0.
4. Age 22 to 80 years of age (inclusive).
5. Diagnosed with an ischemic stroke, confirmed by CT4 or MRI5 imaging.
6. 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.
7. Four to 21 days from stroke onset (or last known well).
8. Pre-stroke mRS of 0.
9. Able to sit with the investigational device for 40 consecutive minutes, in the opinion of the investigator or designee.
10. Can follow a 3-step command, such as "take the paper, fold it in half, and return it to me".
11. Willingness to participate in an exercise activity during study intervention sessions.
12. 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.
13. 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
14. Informed consent signed by subject.
Exclusion Criteria:
1. Hemineglect impairment (NIHSS item 11, score \>0).
2. Implanted active electronic or passive MR-incompatible devices.
3. 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.
4. 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
5. 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.
6. Unstable serious illness/condition (eg, active cancer, severe heart failure, active major psychiatric condition) or life expectancy of less than 12 months.
7. A known severe allergic reaction to acrylic-based adhesives.
8. Alcohol abuse and/or illicit drug abuse in the past 6 months, which is likely to influence ability to fully participate in the trial.
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.
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