A single-center, assessor-blinded, randomized controlled clinical trial to test the safety and efficacy of a novel brain-computer interface controlled functional electrical stimulation (BCI-FES) intervention for gait rehabilitation in the chronic stroke population.

BACKGROUND: In the United States, there are over seven million stroke survivors, with many facing gait impairments due to foot drop. This restricts their community ambulation and hinders functional independence, leading to several long-term health complications. Despite the best available physical therapy, gait function is incompletely recovered, and this occurs mainly during the acute phase post-stroke. Therapeutic options are limited currently. Novel therapies based on neurobiological principles have the potential to lead to long-term functional improvements. The Brain-Computer Interface (BCI) controlled Functional Electrical Stimulation (FES) system is one such strategy. It is based on Hebbian principles and has shown promise in early feasibility studies. The current study describes the BCI-FES clinical trial, which examines the safety and efficacy of this system, compared to conventional physical therapy (PT), to improve gait velocity for those with chronic gait impairment post-stroke. The trial also aims to find other secondary factors that may impact or accompany these improvements and establish the potential of Hebbian-based rehabilitation therapies. METHODS: This Phase II clinical trial is a two-arm, randomized, controlled, longitudinal study with 66 stroke participants in the chronic (> 6 months) stage of gait impairment. The participants undergo either BCI-FES paired with PT or dose-matched PT sessions (three times weekly for four weeks). The primary outcome is gait velocity (10-meter walk test), and secondary outcomes include gait endurance, range of motion, strength, sensation, quality of life, and neurophysiological biomarkers. These measures are acquired longitudinally. DISCUSSION: BCI-FES holds promise for gait velocity improvements in stroke patients. This clinical trial will evaluate the safety and efficacy of BCI-FES therapy when compared to dose-matched conventional therapy. The success of this trial will inform the potential utility of a Phase III efficacy trial. TRIAL REGISTRATION: The trial was registered as "BCI-FES Therapy for Stroke Rehabilitation" on February 19, 2020, at clinicaltrials.gov with the identifier NCT04279067.

Online Laboratory Experiment Learning Module for Biomedical Engineering Physiological Laboratory Courses.

By early spring 2020, the COVID-19 pandemic caused mandatory campus closures of academic institutions nationwide, prompting the rapid transition to online instruction. While lectures and exams were more straightforwardly administered online using video-chatting software, many hands-on laboratory-based courses were forced to develop creative solutions. In response to online instructional requirements, instructors at the University of California Irvine developed an online electroencephalography (EEG) laboratory to simulate the laboratory experiment for students unable to perform the experiment on campus. The laboratory experiment was performed and video recorded by the instructional team under three different scenarios to provide students with multiple data sets acquired under various experimental conditions often enacted by students. Students were required to complete a pre-lab quiz, analyze the acquired EEG data offline, complete a post-lab quiz, and submit their laboratory report to communicate their findings prior to final exams. Student performances compared to prior student performances, and qualitative survey responses, were examined to assess the effectiveness of and response to the online laboratory format. Based on student feedback and lab report grades, the majority of students responded positively and demonstrated an understanding of the EEG experiment's learning outcomes. In summary, the online EEG laboratory enabled students to achieve the main learning objectives and become familiar with the laboratory experiment, indicating its success as an alternative laboratory experiment.