Data from: Neurofeedback facilitation enhances post-stroke gait and balance recovery: a randomized 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. (UMIN000010723 at UMIN-CTR
http://www.umin.ac.jp/english/)