Study of Brain-Triggered Muscle and Tongue Stimulation to Improve Stroke Recovery in Adults

What this Trial Is About

Researchers are evaluating whether combining two non-invasive brain stimulation methodsmuscle stimulation of the arm using functional electrical stimulation FES and neurostimulation through the tonguecan improve recovery after stroke. This study focuses on adults who have experienced a stroke and have upper extremity motor impairments, aiming to measure changes in motor function and brain plasticity using behavioral tests and functional MRI scans. Participants are divided into several groups including stroke patients with upper extremity impairments receiving EEG-guided brain-computer interface BCI training combined with muscle and tongue stimulation, stroke patients receiving traditional rehabilitation before starting BCI-FES-tongue therapy, stroke patients receiving standard FES therapy only, healthy controls, and people with stroke risk factors. The study involves training sessions with the EEG-BCI system, muscle and tongue stimulation, and the use of the recoveriX system, which provides real-time visual and tactile feedback paired with imagined hand movements. The intervention periods vary, with some groups receiving delayed therapy and others immediate BCI therapy. Participants will undergo multiple assessments including behavioral tests of upper extremity function, EEG recordings, and functional MRI scans at the start and after about four months of therapy. The researchers will monitor changes in arm function using the Action Research Arm Test and observe brain activity changes through EEG and fMRI. The study includes up to six BCI training sessions and regular evaluations over approximately 10 weeks, with some groups receiving additional follow-up MRI and behavioral testing. Safety screening excludes those with allergies to electrode materials or contraindications for MRI, and pregnant women are not eligible.

A Closed Loop Neural Activity Triggered Stroke Rehabilitation Device