Clinical trial design to validate a BCI-supported task-specific training in neurorehabilitation after stroke

Introduction: Motor Imagery (MI) was proposed to enhance motor recovery after stroke. EEG-based Brain Computer Interfaces (BCI) operated by MI can provide monitoring and reinforcement of such task-specific training. A BCI rehabilitation device was specifically developed for recovery of hand function after stroke. Here we report the validation of this device, conducted in accordance with the guidelines to demonstrate the efficacy of novel rehabilitation interventions. Methods: 16 stroke patients were consecutively recruited upon their admission to the clinic for post-stroke rehabilitation treatment, and randomly assigned to the BCIsupported MI group (BCI) or MI control group (CTRL). The primary outcome measure was the arm section of the Fugl-Meyer scale. A minimal clinically important difference (MCID) for this scale was described to 7 points. Secondary outcome measures were European Stroke Scale and the arm MRC scale for muscle strength. Results: No significant group differences at baseline were found on primary and secondary outcome measures. Regarding the primary outcome measure, a mean change of 9.3 (+45%) was observed in the BCI group, exceeding the MCID of 7, with respect to an improvement of 5.62 (+9%) observed in CTRL control group. Conclusion: To our knowledge this is the first randomized controlled trial to evaluate the efficacy of BCI-supported MI for motor recovery after stroke. Our findings support the efficacy of this approach. Two possible biases were found in the randomization procedure: side of the brain lesion and time from the event. Acknowledgements: This work is supported by the European ICT Programme Project FP7-224631.