Q Therapeutic System for Chronic Stroke Recovery

This 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 management of chronic stroke patients. Primarily, the trial will assess the System's impact on the upper extremity function through objective, validated clinical assessments. Secondary endpoints will evaluate additional functional and global disability, quality-of-life and safety outcomes.

The study intervention will consist of a total of 5 sessions per week over a period of 3 months (12 weeks) for a total of up to 60 sessions. Each participant must complete at least 40 sessions over the 12-week period to complete the protocol. No extra time will be given to complete all 60 sessions. Each session will last up to 60 minutes during which 40 minutes of active stimulation using the BQ 3.0 System will be administered to participants. The 40 minutes of stimulation will be paired with seated upper extremity (UE) exercises. Lastly, the device will be removed and 10 minutes of standing balance and LE strengthening exercises will be performed without stimulation. A battery of clinical assessments will be conducted before and after the 60 exercise sessions.

Inclusion criteria

• FMA-UE score between 22-50 (inclusive) of impaired limb.
• Difference between Screening and Baseline visit FMA-UE is 3 points or fewer.
• Age 18 to 80 years of age (inclusive).
• Stroke due to ischemia or to intracerebral hemorrhage.
• >6 months to 5 years from index stroke onset.
• Box & Block Test score with affected arm is ≥1 block in 60 seconds at Baseline Visit.
• 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.
• Willingness to participate in physical exercises during study intervention sessions.
• Availability of a relative or other caregiver able to assist during study treatment sessions and visits.
• If female, not pregnant or breastfeeding or planning pregnancy during the study period.
• Informed consent signed by subject.

Exclusion criteria

• Severe neglect impairment interfering with assessments or treatments.
• Severe depression, defined as GDS Score >10/15
• The presence of MR-incompatible implanted devices or MR-incompatible retained objects; 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 UE spasticity, defined as presence of upper extremity contracture or modified Ashworth Scale score≥3 in either biceps or pectoralis
• Pre-existing neurological condition (eg, 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.
• Unstable serious illness/condition (eg, active cancer, severe heart failure, active major psychiatric condition) or life expectancy of less than 12 months.
• 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 interventional trial that would conflict with the current study or clinical endpoint interference may occur.
• Participation in an upper extremity rehabilitation program provided by a licensed provider in the 4 weeks prior to the Screening visit, or a or planned participation in such program at any time between the Screening Visit and the primary endpoint visit.
• Employee of the Sponsor.
• Prisoner.