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CLINICAL TRIAL article

Front. Neurosci.

Sec. Neuroprosthetics

Volume 19 - 2025 | doi: 10.3389/fnins.2025.1579988

The ReHand-BCI trial: a randomized controlled trial of a braincomputer interface for upper extremity stroke neurorehabilitation

Provisionally accepted
Jessica  Cantillo-NegreteJessica Cantillo-Negrete1*Martín  Emiliano Rodríguez-GarcíaMartín Emiliano Rodríguez-García2Paul  Carrillo-MoraPaul Carrillo-Mora1Oscar  Arias-CarriónOscar Arias-Carrión3Emmanuel  Ortega-RoblesEmmanuel Ortega-Robles3Marlene  A Galicia-AlvaradoMarlene A Galicia-Alvarado1Raquel  Valdés- CristernaRaquel Valdés- Cristerna2Ana  G Ramirez-NavaAna G Ramirez-Nava1Claudia  Hernandez-ArenasClaudia Hernandez-Arenas1Jimena  Quinzaños-FresnedoJimena Quinzaños-Fresnedo1Ma. del Refugio  Pacheco-GallegosMa. del Refugio Pacheco-Gallegos1Norma  Marín-ArriagaNorma Marín-Arriaga1Ruben  I Carino-EscobarRuben I Carino-Escobar1
  • 1National Institute of Rehabilitation Luis Guillermo Ibarra Ibarra, Tlalpan, Mexico
  • 2Metropolitan Autonomous University, Mexico City, México, Mexico
  • 3Hospital General Dr. Manuel Gea Gonzalez, Mexico City, México, Mexico

The final, formatted version of the article will be published soon.

Background: 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. Methods: 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. Results: 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. Trial Registration: https://clinicaltrials.gov/, NCT04724824.

Keywords: Brain-computer interface, Stroke, EEG, robot, Magnetic Resonance Imaging, Transcranial Magnetic Stimulation

Received: 19 Feb 2025; Accepted: 02 Jun 2025.

Copyright: © 2025 Cantillo-Negrete, Rodríguez-García, Carrillo-Mora, Arias-Carrión, Ortega-Robles, Galicia-Alvarado, Valdés- Cristerna, Ramirez-Nava, Hernandez-Arenas, Quinzaños-Fresnedo, Pacheco-Gallegos, Marín-Arriaga and Carino-Escobar. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Jessica Cantillo-Negrete, National Institute of Rehabilitation Luis Guillermo Ibarra Ibarra, Tlalpan, Mexico

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