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.
Highlights
StrokeEach year there are approximately 800,000 new incidences of stroke in the United States (Benjamin et al, 2017), and in 2010 there were an estimated 16.9 million stroke events globally (Mozaffarian et al, 2015)
Likelihood ratio tests of linear mixed effect (LME) models over time periods 1–3 controlling for severity, gender, chronicity, and concordance did demonstrate a significant effect of time on Action research arm test (ARAT) outcome score improvement (p = 0.02754) (Table 2)
None of the analyses revealed any significant negative effect of delaying Brain–computer interfaces (BCIs) treatments for participants
Summary
StrokeEach year there are approximately 800,000 new incidences of stroke in the United States (Benjamin et al, 2017), and in 2010 there were an estimated 16.9 million stroke events globally (Mozaffarian et al, 2015). Despite recent advances in acute care, an increasing number of stroke survivors face long-term motor deficits (Benjamin et al, 2017). Costs of care for long-term disability resulting from stroke are substantial with the direct medical costs of stroke estimated to $17.9 billion in 2013 (Benjamin et al, 2017). It is crucial that motor therapy for stroke enhances a survivor’s capacity to autonomously participate in activities of daily living (ADLs), thereby decreasing dependency on caregivers as well as the cost and level of care necessary (Dombovy, 2009; Stinear, 2016). Efficacious motor therapy should be designed to improve the overall quality of life for the individual survivor based on their goals and needs (Remsik et al, 2016; Stinear, 2016)
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