Brain-controlled functional electrical stimulation therapy for gait rehabilitation after stroke: a safety study

作者：McCrimmon Colin M^*; King Christine E; Wang Po T; Cramer Steven C; Nenadic Zoran; Do An H

来源：Journal of NeuroEngineering and Rehabilitation, 2015, 12(1): 57.

DOI：10.1186/s12984-015-0050-4

• Gait therapy
• Stroke recovery
• Brain computer interface
• Electrical stimulation
• EEG
• Dorsiflexion

Background: Many stroke survivors have significant long-term gait impairment, often involving foot drop. Current physiotherapies provide limited recovery. Orthoses substitute for ankle strength, but they provide no lasting therapeutic effect. Brain-computer interface (BCI)-controlled functional electrical stimulation (FES) is a novel rehabilitative approach that may generate permanent neurological improvements. This study explores the safety and feasibility of a foot-drop-targeted BCI-FES physiotherapy in chronic stroke survivors.
Methods: Subjects (n = 9) operated an electroencephalogram-based BCI-FES system for foot dorsiflexion in 12 one-hour sessions over four weeks. Gait speed, dorsiflexion active range of motion (AROM), six-minute walk distance (6MWD), and Fugl-Meyer leg motor (FM-LM) scores were assessed before, during, and after therapy. The primary safety outcome measure was the proportion of subjects that deteriorated in gait speed by >= 0.16 m/s at one week or four weeks post-therapy. The secondary outcome measures were the proportion of subjects that experienced a clinically relevant decrease in dorsiflexion AROM (>= 2.5 degrees), 6MWD (>= 20 %), and FM-LM score (>= 10 %) at either post-therapy assessment.
Results: No subjects (0/9) experienced a clinically significant deterioration in gait speed, dorsiflexion AROM, 6MWT distance, or FM-LM score at either post-therapy assessment. Five subjects demonstrated a detectable increase (>= 0.06 m/s) in gait speed, three subjects demonstrated a detectable increase (>= 2.5 degrees) in dorsiflexion AROM, five subjects demonstrated a detectable increase (>= 10 %) in 6MWD, and three subjects demonstrated a detectable increase (>= 10 %) in FM-LM. Five of the six subjects that exhibited a detectable increase in either post-therapy gait speed or 6MWD also exhibited significant (p < 0.01 using a Mann-Whitney U test) increases in electroencephalogram event-related synchronization/desynchronization. Additionally, two subjects experienced a clinically important increase (>= 0.16 m/s) in gait speed, and four subjects experienced a clinically important increase (>= 20 %) in 6MWD. Linear mixed models of gait speed, dorsiflexion AROM, 6MWD, and FM-LM scores suggest that BCI-FES therapy is associated with an increase in lower motor performance at a statistically, yet not clinically, significant level.
Conclusion: BCI-FES therapy is safe. If it is shown to improve post-stroke gait function in future studies, it could provide a new gait rehabilitation option for severely impaired patients. Formal clinical trials are warranted.

• 出版日期2015-7-11