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<p>The IpsiHand™ System is an FDA-authorized, non-invasive therapy for chronic stroke-induced upper limb motor impairment that uses a brain-computer interface (BCI) to translate intent-to-move signals into hand movement. This retrospective study evaluated real-world outcomes in stroke survivors ≥ 6 months post-stroke who were prescribed IpsiHand™ and completed regular Upper Extremity Fugl-Meyer (UEFM) assessments as part of routine care. Patients were categorized as early responders (achieving the minimal clinically important difference [MCID] of 5.25 points in UEFM score by 6 weeks), intermediate responders (achieving MCID by 12 weeks but not at 6), or early non-responders (not reaching MCID by 12 weeks). Early responders showed statistically significant improvement in upper extremity function compared to early non-responders at both 18 weeks (<i>p</i> &lt; 0.01) and 24 weeks (<i>p</i> &lt; 0.05, Kruskal-Wallis test). Early responders also showed numerically greater improvement than intermediate responders. Overall, 70% (39/56) of participants achieved MCID over the 55-week observation period. These findings suggest that the majority of chronic stroke survivors experienced meaningful functional gains with IpsiHand™ over time, including beyond 12 weeks. While longer use may benefit some individuals who initially did not respond, further prospective research is warranted to determine optimal treatment duration and identify characteristics of responders.</p>

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A retrospective analysis of post-stroke rehabilitation with real world use of brain-computer interface

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月21日

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  • Neha K. Prasad,
  • Nikhita J. Perry,
  • Allison L. Goldring,
  • Lee A. Fleisher,
  • Leo Petrossian,
  • Eric C. Leuthardt,
  • Lauren Souders,
  • Seth J. Wilk

摘要

The IpsiHand™ System is an FDA-authorized, non-invasive therapy for chronic stroke-induced upper limb motor impairment that uses a brain-computer interface (BCI) to translate intent-to-move signals into hand movement. This retrospective study evaluated real-world outcomes in stroke survivors ≥ 6 months post-stroke who were prescribed IpsiHand™ and completed regular Upper Extremity Fugl-Meyer (UEFM) assessments as part of routine care. Patients were categorized as early responders (achieving the minimal clinically important difference [MCID] of 5.25 points in UEFM score by 6 weeks), intermediate responders (achieving MCID by 12 weeks but not at 6), or early non-responders (not reaching MCID by 12 weeks). Early responders showed statistically significant improvement in upper extremity function compared to early non-responders at both 18 weeks (p < 0.01) and 24 weeks (p < 0.05, Kruskal-Wallis test). Early responders also showed numerically greater improvement than intermediate responders. Overall, 70% (39/56) of participants achieved MCID over the 55-week observation period. These findings suggest that the majority of chronic stroke survivors experienced meaningful functional gains with IpsiHand™ over time, including beyond 12 weeks. While longer use may benefit some individuals who initially did not respond, further prospective research is warranted to determine optimal treatment duration and identify characteristics of responders.