Frequency-tuned Electromagnetic Field Treatment to Facilitate Recovery of Patients With Chronic Stroke
University of Florida
Summary
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.
Description
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 b…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Upper Extremity Fugl-Meyer Assessment score between 22-50 (inclusive) of impaired limb. 2. Upper Extremity Fugl-Meyer Assessment score is within up to 3-point difference between Screening and Baseline visit. 3. Age 18 to 80 years of age (inclusive). 4. Stroke due to ischemia or to intracerebral hemorrhage. 5. \>6 months to 5 years from stroke onset. 6. Box \& Block Test score with affected arm is ≥1 block in 60 seconds. 7. Able to sit with the investigational system for 40 consecutive minutes. 8. Can follow a 3-step command, such as "take the paper, fold it in half, and…
Interventions
- 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.
Location
- Brooks Rehabilitation Clinical Research CenterJacksonville, Florida