Cantillo-Negrete Jessica, Rodríguez-García Martín Emiliano, Carrillo-Mora Paul, Arias-Carrión Oscar, Ortega-Robles Emmanuel, Galicia-Alvarado Marlene A, Valdés-Cristerna Raquel, Ramirez-Nava Ana G, Hernandez-Arenas Claudia, Quinzaños-Fresnedo Jimena, Pacheco-Gallegos Ma Del Refugio, Marín-Arriaga Norma, Carino-Escobar Ruben I
Technological Research Subdirection, Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra, Mexico City, Mexico.
Electrical Engineering Department, Universidad Autonoma Metropolitana - Iztapalapa, Mexico City, Mexico.
Front Neurosci. 2025 Jun 18;19:1579988. doi: 10.3389/fnins.2025.1579988. eCollection 2025.
Brain-computer interfaces (BCI) are a promising complementary therapy for stroke rehabilitation due to the close-loop feedback that can be provided with these systems, but more evidence is needed regarding their clinical and neuroplasticity effects.
A randomized controlled trial was performed using the ReHand-BCI system that provides feedback with a robotic hand orthosis. The experimental group (EG) used the ReHand-BCI, while sham-BCI was given to the control group (CG). Both groups performed 30 therapy sessions, with primary outcomes being the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE) and the Action Research Arm Test (ARAT). Secondary outcomes were hemispheric dominance, measured with electroencephalography and functional magnetic resonance imaging, white matter integrity via diffusion tensor imaging, and corticospinal tract integrity and excitability, measured with transcranial magnetic stimulation.
At post-treatment, patients in both groups had significantly different FMA-UE scores (EG: baseline = 24.5[20, 36], post-treatment 28[23, 43], CG: baseline = 26[16, 37.5], post-treatment = 34[17.3, 46.5]), while only the EG had significantly different ARAT scores at post-treatment (EG: baseline = 8.5[5, 26], post-treatment = 20[7, 36], CG: baseline = 3[1.8, 30.5], post-treatment = 15[2.5, 40.8]). In addition, across the intervention, the EG showed trends of more pronounced ipsilesional cortical activity and higher ipsilesional corticospinal tract integrity, although these differences were not statistically different compared to the control group, likely due to the study's sample size.
To the authors' knowledge, this is the first clinical trial that has assessed such a wide range of physiological effects across a long BCI intervention, implying that a more pronounced ipsilesional hemispheric dominance is associated with upper extremity motor recovery. Therefore, the study brings light into the neuroplasticity effects of a closed-loop BCI-based neurorehabilitation intervention in stroke.
https://clinicaltrials.gov/, identifier NCT04724824.
脑机接口(BCI)作为一种有前景的辅助治疗手段,可用于中风康复,因为这些系统能够提供闭环反馈,但关于其临床和神经可塑性影响,仍需更多证据。
使用ReHand-BCI系统进行了一项随机对照试验,该系统通过机器人手部矫形器提供反馈。实验组(EG)使用ReHand-BCI,而对照组(CG)使用假BCI。两组均进行30次治疗,主要结局指标为上肢Fugl-Meyer评估(FMA-UE)和动作研究臂测试(ARAT)。次要结局指标包括通过脑电图和功能磁共振成像测量的半球优势、通过扩散张量成像测量的白质完整性,以及通过经颅磁刺激测量的皮质脊髓束完整性和兴奋性。
治疗后,两组患者的FMA-UE评分存在显著差异(EG:基线=24.5[20, 36],治疗后=28[23, 43];CG:基线=26[16, 37.5],治疗后=34[17.3, 46.5]),而只有实验组在治疗后的ARAT评分存在显著差异(EG:基线=8.5[5, 26],治疗后=20[7, 36];CG:基线=3[1.8, 30.5],治疗后=15[2.5, 40.8])。此外,在整个干预过程中尽管与对照组相比这些差异无统计学意义(可能由于研究样本量原因),但实验组显示出病侧皮质活动更明显和病侧皮质脊髓束完整性更高的趋势。
据作者所知,这是第一项评估长时间BCI干预对如此广泛生理效应的临床试验,这意味着病侧半球优势更明显与上肢运动恢复相关。因此,该研究揭示了基于闭环BCI的神经康复干预对中风患者神经可塑性的影响。