Trial reportFrontiers in neurology
Closed-loop motor imagery brain-computer interface-assisted training for upper limb rehabilitation after subacute stroke: clinical and electroencephalographic outcomes from a randomized pilot trial.
Trial report in Frontiers in neurology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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12 authors.
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Abstract
Background: Closed-loop motor imagery brain-computer interface (MI-BCI) training may support post-stroke upper-limb rehabilitation by coupling motor intention with contingent multisensory feedback. This randomized pilot trial examined its feasibility, safety, short-term clinical effects, and exploratory EEG correlates in patients with subacute stroke. Methods: In this single-center, assessor-blinded, two-arm pilot trial, 40 patients with first-ever subcortical stroke in the subacute phase were randomized 1:1 to a BCI group or an active control group after a 2-day motor imagery familiarization phase. Both groups received routine medical management, standardized conventional rehabilitation, and dose-matched motor imagery-based hand training for 4 weeks. The BCI group received EEG-contingent closed-loop MI-BCI-assisted training with a soft rehabilitation glove, whereas the control group received non-EEG-contingent glove-assisted motor imagery training under matched training duration, task instructions, device exposure, and multisensory feedback. The primary outcome was the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE). Secondary outcomes included the Action Research Arm Test (ARAT) and Modified Barthel Index (MBI). Exploratory EEG outcomes included FFT%α and FFT%β during motor imagery. Clinical and EEG outcomes were analyzed using baseline-adjusted ANCOVA models, with week-4 values as dependent variables and corresponding baseline values as covariates. Results: All randomized participants completed the 4-week assessment. In baseline-adjusted ANCOVA models, the BCI group showed higher week-4 scores than the control group for FMA-UE (adjusted mean difference, 13.40 points; 95% CI, 10.71-16.08; Conclusion: Closed-loop MI-BCI-assisted training was feasible and well tolerated in selected patients with subacute stroke. The observed short-term improvements in upper-limb impairment and activity capacity provide preliminary signals of potential benefit beyond dose-matched non-EEG-contingent feedback training. Exploratory EEG findings suggest task-related modulation of alpha- and beta-band sensorimotor rhythmic activity, but should be interpreted as hypothesis-generating rather than confirmatory evidence of neural reorganization. Larger multicenter trials with longer follow-up, rigorous neurophysiological analyses, and real-world upper-limb use outcomes are needed. Clinical Trial Registration: ChiCTR2400083992. https://www.chictr.org.cn/showproj.html?proj=229529.
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