Motor Conditioning to Enhance the Effect of Physical Therapy

About this trial

This trial is enrolling individuals with cervical (neck area) spinal cord injuries to test a brain-controlled device paired with another stimulation device to activate hand muscles. A brain-computer interface (BCI) device records brain signals corresponding to a visual cue — e.g., a hand squeezing a ball. With training, users can initiate movements on the screen using their thoughts. These movements can then be used to activate functional electrical stimulation (FES), a technique that applies electrical current through the skin to nerves to contract weakened or paralyzed muscles. Thus, a motor command from the brain is recorded by BCI and sent to the FES device (BCI-FES). The study will measure functional changes (range of movement, muscle strength, grip force, independence), neurological outcomes (electroencephalogram or EEG activity), and quality of life factors. If selected for the trial, participants will each receive 20 physical therapy sessions of matched duration (40-50 min) of their dominant hand. They will be randomly assigned to one of two study groups: 1) participating in physical therapy only (control group); or 2) the treatment group, with BCI-FES and physical therapy. Researchers will measure changes in hand function after stimulation and before adding physical therapy; they want to see if this sequence conditions the hands to better respond to the therapy.