Behavioral Outcomes Following Brain–Computer Interface Intervention for Upper Extremity Rehabilitation in Stroke: A Randomized Controlled Trial

Abstract

Stroke is a leading cause of persistent upper extremity (UE) motor disability in adults. Brain–computer interface (BCI) intervention has demonstrated potential as a motor rehabilitation strategy for stroke survivors. This sub-analysis of ongoing clinical trial (NCT02098265) examines rehabilitative efficacy of this BCI design and seeks to identify stroke participant characteristics associated with behavioral improvement. Stroke participants (n = 21) with UE impairment were assessed using Action Research Arm Test (ARAT) and measures of function. Nine participants completed three assessments during the experimental BCI intervention period and at 1-month follow-up. Twelve other participants first completed three assessments over a parallel time-matched control period and then crossed over into the BCI intervention condition 1-month later. Participants who realized positive change (≥1 point) in total ARAT performance of the stroke affected UE between the first and third assessments of the intervention period were dichotomized as “responders” (<1 = “non-responders”) and similarly analyzed. Of the 14 participants with room for ARAT improvement, 64% (9/14) showed some positive change at completion and approximately 43% (6/14) of the participants had changes of minimal detectable change (MDC = 3 pts) or minimally clinical important difference (MCID = 5.7 points). Participants with room for improvement in the primary outcome measure made significant mean gains in ARATtotal score at completion (ΔARATtotal = 2, p = 0.028) and 1-month follow-up (ΔARATtotal = 3.4, p = 0.0010), controlling for severity, gender, chronicity, and concordance. Secondary outcome measures, SISmobility, SISadl, SISstrength, and 9HPTaffected, also showed significant improvement over time during intervention. Participants in intervention through follow-up showed a significantly increased improvement rate in SISstrength compared to controls (p = 0.0117), controlling for severity, chronicity, gender, as well as the individual effects of time and intervention type. Participants who best responded to BCI intervention, as evaluated by ARAT score improvement, showed significantly increased outcome values through completion and follow-up for SISmobility (p = 0.0002, p = 0.002) and SISstrength (p = 0.04995, p = 0.0483). These findings may suggest possible secondary outcome measure patterns indicative of increased improvement resulting from this BCI intervention regimen as well as demonstrating primary efficacy of this BCI design for treatment of UE impairment in stroke survivors.Clinical Trial Registration: ClinicalTrials.gov, NCT02098265.

Immediate and long-term effects of BCI-based rehabilitation of the upper extremity after stroke: a systematic review and meta-analysis

“…A total of 1015 records were screened, of which the full texts of 80 were assessed for eligibility. Finally, 33 studies were included in the current systematic review [6, 7, 15-17, 26, 35, 37, 46, 47, 49-71], of which 18 studies were of single-group design [26,37,[56][57][58][59][60][61][62][63][64][65][66][67][68][69][70][71], and 15 studies were of controlled-trial design [6, 7, 15-17, 35, 46, 47, 49-55]. In the current review, only studies with a controlled-trial design were included in our metaanalysis, and those with single-group designs were only included in our qualitative description.…”

Immersive Virtual Reality for Clinical Pain: Considerations for Effective Therapy

“…The use of motor imagery in VR-BCI is a good example of how these two technologies can potentially be combined. Although a large part of the research combining these techniques has been in healthy participants (e.g., Ortner et al, 2012;Lupu et al, 2018;, or is still at proof-of-concept stage (Aamer et al, 2019), early clinical studies have shown promise for neurorehabilitation (Remsik et al, 2018;Cohen et al, 2019;Vourvopoulos et al, 2019). However, the spatiotemporal imprecision is currently a limiting factor.…”

Ipsilesional Mu Rhythm Desynchronization and Changes in Motor Behavior Following Post Stroke BCI Intervention for Motor Rehabilitation

“…Participant characteristics are displayed in Table 1 . This interim analysis of the larger ongoing study seeks to elucidate the electrophysiological consequences and associations of BCI participation and the authors focus specifically on the behavioral (primary outcome) associations in another manuscript published in tandem with this effort ( Remsik et al, 2018 ).…”