This trial will test a promising new intervention to promote post-stroke neural reorganization and functional recovery. The overall aim is to identify a systematic, methodological approach to system fitting, training protocols, and optimization of collecting outcome measures.
Aim 1: Assess the safety of using the Q Therapeutic (BQ 3.0) System, including in-clinic and at- extremity rehabilitation training for individuals with chronic stroke, as determined by the number of adverse events. Device deficiencies will also be recorded to detect operational reliability.
Aim 2: Evaluate the effectiveness of the Q Therapeutic (BQ 3.0) System for individuals with chronic stroke in improving upper extremity function as determined by change in functional outcome measures after 3-month treatment, including in-clinic and at-home sessions.
Be between ages 18-80
Have an score between 22-50 (inclusive) of impaired limb on the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE), as determined by study staff
Have upper extremity function that is not changing much over time (as determined by study staff based on assessments I complete at screening and before treatment starts)
Have stroke due to ischemia or to intracerebral hemorrhage • Be >6 months to 5 years from stroke onset
Be younger than 18 years old or older than 80
Have implanted MR-incompatible devices or MR-incompatible retained objects (like shrapnel) or an implanted life-sustaining MR-compatible devices (such as a pacemaker or internal cardiac defibrillator)
Have alcohol abuse and/or drug abuse in the past 6 months, which is likely to influence ability to fully participate in the trial
Had active participation in an arm rehabilitation program with a therapist in the 4 weeks prior to the screening visit
Single group
Experimental (Q Therapeutic System (BQ 3.0)
DeviceDevice: Q Therapeutic System (BQ 3.0) - Active The BQ 3.0 is a medical device that produces and delivers non-invasive, extremely low intensity and frequency (1-100 Hz.; 0.1-1.0 G), frequency tuned electromagnetic fields in order to stimulate neuronal networks with the aim of reducing disability and promoting neurorecovery.
Mean change of FMA-UE score
Mean change of FMA-UE score from Baseline to the 3-months follow-up visit. A performance measure used to assess arm function. 33 items are scored on a scale of 0 to 2, where 0=cannot perform, 1=performs partially and 2=performs fully. An increase in score reflects an improvement in arm function.
Safety endpoints: Cumulative incidence of adverse events
The number of adverse events reported throughout the study.
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Kessler Foundation
Lead sponsor
BrainQ Technologies Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
