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

I hate the weasel words of further clinical trials are warranted.  Write up a stroke protocol so at least we can prove whether this works in real life applications.
http://www.jneuroengrehab.com/content/12/1/57

Colin M. McCrimmon^1*, Christine E. King¹, Po T. Wang¹, Steven C. Cramer²³⁴, Zoran Nenadic^15* and An H. Do²

• * Corresponding authors: Colin M McCrimmon cmccrimm@uci.edu - Zoran Nenadic znenadic@uci.edu

Author Affiliations

¹ Department of Biomedical Engineering, University of California, Irvine 92697, CA, USA
² Department of Neurology, University of California, Irvine, Orange 92868, CA, USA
³ Department of Anatomy & Neurology, University of California, Irvine 92697, CA, USA
⁴ Department of Physical Medicine & Rehabilitation, University of California, Irvine, Orange 92868, CA, USA
⁵ Department of Electrical Engineering and Computer Science, University of California, Irvine 92697, CA, USA

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Journal of NeuroEngineering and Rehabilitation 2015, 12:57  doi:10.1186/s12984-015-0050-4
The electronic version of this article is the complete one and can be found online at: http://www.jneuroengrehab.com/content/12/1/57

Received:	18 February 2015
Accepted:	23 June 2015
Published:	11 July 2015

© 2015 McCrimmon et al.

This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Abstract

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°), 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°) 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.