Frequency-tuned Electromagnetic Field Treatment to Facilitate Recovery of Patients With Chronic Stroke
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.
• 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.