Effect of Neurofeedback Facilitation on Post-stroke Gait and Balance Recovery: A Randomized Controlled Trial.

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.