Application of Functional Electrical Stimulation Therapy Coupled to a P300-based Brain-Computer Interface for Paretic Upper Limb Rehabilitation in Chronic Stroke: A Randomized Controlled Trial

What this Trial Is About

Researchers are studying an experimental therapy to help people recover arm movement after a stroke. This therapy combines functional electrical stimulation with a P-300 based Brain-Computer Interface system (BCI-FES) to assist arm rehabilitation. The study compares two groups: one receives only conventional physical therapy, and the other receives both conventional therapy and BCI-FES. The goal is to improve motor recovery and independence in patients with moderate to severe upper limb weakness due to stroke. Both groups will undergo 20 sessions of conventional physical therapy over 4 weeks, with five sessions each week. The experimental group will also receive 20 sessions of BCI-FES therapy during the same period. The BCI system detects the patient's intended hand movements and assists with movements such as hand opening, grasping, pinching, pronation, and supination. These movements are practiced alongside daily tasks using objects like bottles and spoons. The therapy aims to stimulate brain pathways involved in movement to support recovery. Participants will be evaluated before and after the 4-week treatment using tests that measure arm motor function, spasticity, independence, and depression. Brain imaging with MRI and EEG will assess changes in brain structure and activity. Safety and comfort during sessions will be monitored, including fatigue and skin irritation. The total involvement lasts about one month, with close follow-up during therapy and assessments of progress and brain changes.

BCI-FES for Upper Limb Rehabilitation in Chronic Stroke