Remsik Alexander B, Dodd Keith, Williams Leroy, Thoma Jaclyn, Jacobson Tyler, Allen Janerra D, Advani Hemali, Mohanty Rosaleena, McMillan Matt, Rajan Shruti, Walczak Matt, Young Brittany M, Nigogosyan Zack, Rivera Cameron A, Mazrooyisebdani Mohsen, Tellapragada Neelima, Walton Leo M, Gjini Klevest, van Kan Peter L E, Kang Theresa J, Sattin Justin A, Nair Veena A, Edwards Dorothy Farrar, Williams Justin C, Prabhakaran Vivek
Department of Radiology, University of Wisconsin - Madison, Madison, WI, United States.
Department of Kinesiology, University of Wisconsin - Madison, Madison, WI, United States.
Front Neurosci. 2018 Nov 8;12:752. doi: 10.3389/fnins.2018.00752. eCollection 2018.
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 ( = 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 ARAT score at completion (ΔARAT = 2, = 0.028) and 1-month follow-up (ΔARAT = 3.4, = 0.0010), controlling for severity, gender, chronicity, and concordance. Secondary outcome measures, SIS, SIS, SIS, and 9HPT, also showed significant improvement over time during intervention. Participants in intervention through follow-up showed a significantly increased improvement rate in SIS compared to controls ( = 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 SIS ( = 0.0002, = 0.002) and SIS ( = 0.04995, = 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. ClinicalTrials.gov, NCT02098265.
中风是成人持续性上肢运动功能障碍的主要原因。脑机接口（BCI）干预已显示出作为中风幸存者运动康复策略的潜力。这项对正在进行的临床试验（NCT02098265）的亚分析研究了这种BCI设计的康复效果，并试图确定与行为改善相关的中风参与者特征。使用动作研究臂测试（ARAT）和功能测量对有上肢损伤的中风参与者（n = 21）进行评估。9名参与者在BCI实验干预期间和1个月随访时完成了三次评估。另外12名参与者首先在平行的时间匹配对照期内完成了三次评估，然后在1个月后转入BCI干预组。在干预期的第一次和第三次评估之间，中风患侧上肢的ARAT总表现实现正向变化（≥1分）的参与者被分为“反应者”（<1分 = “无反应者”）并进行类似分析。在14名有ARAT改善空间的参与者中，64%（9/14）在完成时显示出一些正向变化，约43%（6/14）的参与者有最小可检测变化（MDC = 3分）或最小临床重要差异（MCID = 5.7分）的变化。在主要结局指标上有改善空间的参与者在完成时（ΔARAT = 2，P = 0.028）和1个月随访时（ΔARAT = 3.4，P = 0.0010）的ARAT评分有显著的平均提高，同时控制了严重程度、性别、病程和一致性。次要结局指标，即上肢功能状态量表（SIS）、改良Barthel指数（MBI）、Fugl-Meyer评估量表（FMA）和九孔插板试验（9HPT），在干预期间也随时间显示出显著改善。与对照组相比，干预至随访期的参与者在控制了严重程度、病程、性别以及时间和干预类型的个体效应后，SIS的改善率显著增加（P = 0.0117）。根据ARAT评分改善评估，对BCI干预反应最佳的参与者在完成和随访时的SIS（P = 0.0002，P = 0.002）和MBI（P = 0.04995，P = 0.0483）结局值显著增加。这些发现可能表明，这种BCI干预方案可能会使次要结局指标出现改善增加的模式，同时也证明了这种BCI设计对中风幸存者上肢损伤治疗的主要疗效。ClinicalTrials.gov，NCT02098265。 （注：原文中多次出现“SIS”未明确具体含义，这里保留英文未翻译；“MBI”“FMA”为医学领域常见指标，根据常见释义进行了补充翻译；“九孔插板试验”为对“9HPT”的意译）
