RESPARK - Brain Q for Chronic Stroke

Prior treatment

• 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
• Alcohol abuse and/or illicit drug abuse in the past 6 months, which is likely to influence ability to fully participate in the trial.

Other illness

• Severe neglect impairment interfering with assessments or treatments.
• 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).
• 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.
• Unstable serious illness/condition (e.g., active cancer, severe heart failure, active major psychiatric condition) or life expectancy of less than 12 months.

Other

• Severe depression, defined as Geriatric Depression Scale (GDS) Score \>10/15
• Severe upper extremity spasticity, defined as presence of contracture or modified Ashworth Scale score ≥3 in either biceps or pectoralis
• Participation in another trial that would conflict with the current study or clinical endpoint interference may occur.
• Active participation in an upper extremity rehabilitation program provided by a licensed provider within 4 weeks from the screening visit and until the primary endpoint visit.
• Employee of the Sponsor.
• Prisoner.

• 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.
• Willingness to participate in physical exercises during study intervention sessions.
• Availability of a relative or other caregiver that is able to participate in training and assist during treatment sessions at Brooks and home during the study duration.
• If female, not pregnant or breastfeeding or planning pregnancy during the study period.
• The subject is able to provide Informed consent.