This trial tests a promising new intervention to promote post-stroke neural reorganization and functional recovery. The Q Therapeutic (BQ 3.0) is a wearable medical system 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. This trial is a prospective, single-arm, open-label, single center clinical trial designed to evaluate the safety, feasibility, and efficacy of the Q Therapeutic (BQ 3.0) System in the rehabilitation of people with chronic stroke.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Upper Extremity Fugl-Meyer Assessment score between 22-50 (inclusive) of impaired limb.
✓. Upper Extremity Fugl-Meyer Assessment score is within up to 3-point difference between Screening and Baseline visit.
✓. Age 18 to 80 years of age (inclusive).
✓. Stroke due to ischemia or to intracerebral hemorrhage.
✓. \>6 months to 5 years from stroke onset.
✓. Box \& Block Test score with affected arm is ≥1 block in 60 seconds.
✓. Able to sit with the investigational system for 40 consecutive minutes.
✓. Can follow a 3-step command, such as "take the paper, fold it in half, and return it to me", or a non-verbal equivalent.
Exclusion criteria
✕. Severe neglect impairment interfering with assessments or treatments.
✕
What they're measuring
1
Change in Fugl-Meyer Assessment - Upper Extremity
Timeframe: Baseline, 3 months after, and 6 months after start of interventions
2
Change from Baseline in Modified Rankin Scale (mRS)
Timeframe: Baseline, 3 months after, and 6 months after the start of interventions
. Severe depression, defined as Geriatric Depression Scale (GDS) Score \>10/15
✕. Presence of implanted or retained MR-incompatible devices or materials, or the presence of life-sustaining MR-compatible devices (e.g. pacemaker or internal cardiac defibrillator).
✕. 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
✕. Botulinum toxin to the paretic arm: received in the prior 3 months OR expected before the 6-Month Visit
✕. Severe upper extremity spasticity, defined as presence of contracture or modified Ashworth Scale score ≥3 in either biceps or pectoralis
✕. Pre-existing neurological condition (e.g., 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.
✕. 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.