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
Kessler Foundation
Lead sponsor
BrainQ Technologies Ltd.
Collaborator