Objective: To test the hypothesis that supplementary motor area (SMA) facilitation with functional near-infrared spectroscopy mediated neurofeedback (fNIRS-NFB) augments post-stroke gait and balance recovery using the 3-meter-Timed Up-and-Go (TUG) test, we conducted this two-center, double-blind, randomized controlled trial involving 54 Japanese patients.

Methods: Patients with subcortical stroke-induced mild-to-moderate gait disturbance more than 12 weeks from onset, underwent 6 sessions of SMA neurofeedback facilitation during gait- and balance-related motor imagery using fNIRS-NFB. Participants were randomly allocated to intervention (REAL: 28 patients) or placebo (SHAM: 26 patients) group. In the REAL group, the fNIRS signal contained participants’ cortical activation information. Primary outcome was TUG improvement, 4 weeks post intervention.

Results: The REAL group showed greater improvement in the TUG test (12.84 ± 15.07 s, 95% CI: 7.00-18.68) than the SHAM group (5.51± 7.64 s, 95% CI: 2.43 – 8.60; group difference 7.33 s, 95% CI: 0.83 – 13.83; p = 0.028), even after adjusting for covariates (group × time interaction; F1.23,61.69 = 4.50, p = 0.030, partial η2 = 0.083). Only the REAL group showed significantly increased imagery-related SMA activation and enhancement of resting-state connectivity between SMA and ventrolateral premotor area. Adverse effects associated with fNIRS-mediated neurofeedback intervention were absent.

Conclusion: SMA facilitation during motor imagery using fNIRS neurofeedback may augment post-stroke gait and balance recovery by modulating the SMA and its related network.

Classification of Evidence: This study provides Class III evidence that for patients with gait disturbance from subcortical stroke, SMA neurofeedback facilitation improves TUG time. (UMIN000010723 at UMIN-CTR http://www.umin.ac.jp/english/)

This is additional information including protocol, detailed methodological procedures, and additional clinical and imaging data.