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Study design Feasibility and preliminary clinical efficacy analysis in a single-arm interventional study. Objectives We developed a brain-computer interface-triggered functional electrical stimulation therapy (BCI-FEST) system for clinical application and conducted an interventional study to (1) assess its feasibility and (2) understand its potential clinical efficacy for the rehabilitation of reaching and grasping in individuals with sub-acute spinal cord injury (SCI). Setting Spinal cord injury rehabilitation hospital-Toronto Rehabilitation Institute-Lyndhurst Centre. Methods Five participants with sub-acute SCI completed between 12 and 40 1-hour sessions using BCI-FEST, with up to 5 sessions a week. We assessed feasibility by measuring participants' compliance with treatment, the occurrence of adverse events, BCI sensitivity, and BCI setup duration. Clinical efficacy was assessed using Functional Independence Measure (FIM) and Spinal Cord Independence Measure (SCIM), as primary outcomes. In addition, we used two upper-limb function tests as secondary outcomes. Results On average, participants completed 29.8 sessions with no adverse events. Only one of the 149 sessions was affected by technical challenges. The BCI sensitivity ranged between 69.5 and 80.2%, and the mean BCI setup duration was ~11 min. In the primary outcomes, three out of five participants showed changes greater than the minimal clinically important differences (MCIDs). Additionally, the mean change in secondary outcome measures met the threshold for detecting MCID as well; four out of five participants achieved MCID. Conclusions The new BCI-FEST intervention is safe, feasible, and promising for the rehabilitation of reaching and grasping after SCI.

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Functional electrical stimulation therapy (FEST) is a promising intervention for the restoration of upper extremity function after cervical spinal cord injury (SCI). This study describes and evaluates a novel FEST system designed to incorporate voluntary movement attempts and massed practice of functional grasp through the use of brain-computer interface (BCI) and computer vision (CV) modules. An EEG-based BCI relying on a single electrode was used to detect movement initiation attempts. A CV system identified the target object and selected the appropriate grasp type. The required grasp type and trigger command were sent to an FES stimulator, which produced one of four multichannel muscle stimulation patterns (precision, lateral, palmar, or lumbrical grasp). The system was evaluated with five neurologically intact participants and one participant with complete cervical SCI. An integrated BCI-CV-FES system was demonstrated. The overall classification accuracy of the CV module was 90.8%, when selecting out of a set of eight objects. The average latency for the BCI module to trigger the movement across all participants was 5.9 ± 1.5 seconds. For the participant with SCI alone, the CV accuracy was 87.5% and the BCI latency was 5.3 ± 9.4 seconds. BCI and CV methods can be integrated into an FEST system without the need for costly resources or lengthy setup times. The result is a clinically relevant system designed to promote voluntary movement attempts and more repetitions of varied functional grasps during FEST.

Functional electrical stimulation therapy (FEST) is a state-of-the-art treatment for retraining motor function after neurological injuries. Recent literature suggests that FEST can be further improved with brain-computer interface (BCI) technology. In this case study, we assessed the feasibility of using BCI-triggered FEST (BCI-FEST) to restore upper limb function in a 57-yr-old man with severe left hemiplegia resulting from a stroke 6 yrs before enrollment in the study. The intervention consisted of two blocks of forty 1-hr BCI-FEST sessions, with three sessions delivered weekly. During therapy, a single-channel BCI was used to trigger the stimulation programmed to facilitate functional movements. The measure of the feasibility of the BCI-FEST included assessing the implementation and safety of the intervention. Clinical improvements were assessed using (a) Functional Independence Measure, (b) Action Research Arm Test, (c) Toronto Rehabilitation Institute – Hand Function Test, and (d) Fugl-Meyer Assessment Upper Extremity test. Upon completion of 80 therapy sessions, 14-, 17-, and 18-point changes were recorded on Action Research Arm Test, Fugl-Meyer Assessment Upper Extremity test, and Toronto Rehabilitation Institute – Hand Function Test, respectively. The participant also indicated improvement as demonstrated by his ability to perform various day-to-day tasks. The results suggest that BCI-FEST is safe and viable.

Context/Objective Integrating brain-computer interface (BCI) technology with functional electrical stimulation therapy (FEST) is an emerging strategy for upper limb motor rehabilitation after spinal cord injury (SCI). Despite promising results, the combined use of these technologies (BCI-FEST) in clinical practice is minimal. To address this issue, we developed KITE-BCI, a BCI system specifically designed for clinical application and integration with dynamic FEST. In this paper, we report its technical features and performance. In addition, we discuss the differences in distributions of the BCI- and therapist-triggered stimulation latencies. Design Two single-arm 40-session interventional studies to test the feasibility of BCI-controlled FEST for upper limb motor rehabilitation in individuals with cervical SCI Setting Rehabilitation programs within the University and Lyndhurst Centres of the Toronto Rehabilitation Institute – University Health Network, Toronto, Canada Participants Five individuals with sub-acute (< 6 months post-injury) SCI at the C4-C5 level, AIS B-D, and three individuals with chronic (> 24 months post-injury) SCI at C4 level, AIS B-C. Outcome Measures We measured BCI setup duration, and to characterize the performance of KITE-BCI, we recorded BCI sensitivity, defined as the percentage of successful BCI activations out of the total number of cued movements. Results The overall BCI sensitivities were 74.46% and 79.08% for the sub-acute and chronic groups, respectively. The average KITE-BCI setup duration across the two studies was 11 min and 13 s. Conclusion KITE-BCI demonstrates a clinically viable single-channel BCI system for integration with FEST resulting in a versatile technology-enhanced upper limb motor rehabilitation strategy after SCI.

Purpose: While current rehabilitation practice for improving arm and hand function relies on physical/occupational therapy, a growing body of research evaluates the effects of technology-enhanced rehabilitation. We review interventions that combine a brain-computer interface (BCI) with electrical stimulation (ES) for upper limb movement rehabilitation to summarize the evidence on (1) populations of study participants, (2) BCI-ES interventions, and (3) the BCI-ES systems. Method: After searching seven databases, two reviewers identified 23 eligible studies. We consolidated information on the study participants, interventions, and approaches used to develop integrated BCI-ES systems. The included studies investigated the use of BCI-ES interventions with stroke and spinal cord injury (SCI) populations. All studies used electroencephalography to collect brain signals for the BCI, and functional electrical stimulation was the most common type of ES. The BCI-ES interventions were typically conducted without a therapist, with sessions varying in both frequency and duration. Results: Of the 23 eligible studies, only 3 studies involved the SCI population, compared to 20 involving individuals with stroke. Conclusions: Future BCI-ES interventional studies could address this gap. Additionally, standardization of device and rehabilitation modalities, and study-appropriate involvement with therapists, can be considered to advance this intervention towards clinical implementation.

Context/Objective Functional electrical stimulation (FES) is commonly used in rehabilitation to generate electrically-induced muscle contractions. FES has been shown to assist in the recovery of voluntary motor functions after stroke or spinal cord injury. However, discomfort associated with FES can motivate patients to withdraw their participation from FES therapy despite its benefits. To address this issue, a functional electrical stimulator, called MyndMove™ (MyndTec Inc., Canada), has been developed to generate more comfortable contractions than conventional stimulators. Design Cross-sectional, interventional, with two treatment arms. Setting A laboratory within a rehabilitation center. Participants Twelve able-bodied participants. Intervention FES delivered with two different stimulators, MyndMove™ and Compex Motion (Compex, Switzerland), during muscle contractions of high, moderate and low stimulation intensity. Outcome Measures Comfort-related preference to a given stimulator and the discomfort score rated through a Numeric Rating Scale (NRS-101) for both stimulators. Results Participants perceived a reduction in discomfort during high-intensity stimulation generated using MyndMove™. In addition, MyndMove™ stimulations were preferred in 60% of all contractions. The reduction in discomfort associated with MyndMove™ might be due the fact that MyndMove™ delivers less charge to generate contractions of equivalent intensity, compared to Compex Motion. Conclusion Reducing discomfort during FES may help in generating stronger and more clinically useful contractions, increasing accessibility of FES therapy to include individuals with low tolerance to FES.