Effect of BCI-Controlled Pedaling Training System With Multiple Modalities of Feedback on Motor and Cognitive Function Rehabilitation of Early Subacute Stroke Patients

Brain-computer interfaces (BCIs) are currently integrated into traditional rehabilitation interventions after stroke. Although BCIs bring many benefits to the rehabilitation process, their effects are limited since many patients cannot concentrate during training. Despite this outcome post-stroke motor-attention dual-task training using BCIs has remained mostly unexplored. This study was a randomized placebo-controlled blinded-endpoint clinical trial to investigate the effects of a BCI-controlled pedaling training system (BCI-PT) on the motor and cognitive function of stroke patients during rehabilitation. A total of 30 early subacute ischemic stroke patients with hemiplegia and cognitive impairment were randomly assigned to the BCI-PT or traditional pedaling training. We used single-channel Fp1 to collect electroencephalography data and analyze the attention index. The BCI-PT system timely provided visual, auditory, and somatosensory feedback to enhance the patient's participation to pedaling based on the real-time attention index. After 24 training sessions, the attention index of the experimental group was significantly higher than that of the control group. The lower limbs motor function (FMA-L) increased by an average of 4.5 points in the BCI-PT group and 2.1 points in the control group (P=0.022) after treatments. The difference was still significant after adjusting for the baseline indicators (β = 2.41, 95%CI: 0.48-4.34, P=0.024). We found that BCI-PT significantly improved the patient's lower limb motor function by increasing the patient's participation. (clinicaltrials.gov: NCT04612426).