A Single-Center, Assessor-Blinded, Randomized Controlled Clinical Trial to Test the Safety and Efficacy of a Novel Brain-Computer Interface Controlled Functional Electrical Stimulation (BCI-FES) Intervention for Gait Rehabilitation in the Chronic Stroke Population

Authors

Piyashi Biswas, University of California, Irvine
Lucy Dodakian, University of California, Irvine
Po T. Wang, University of California, Irvine
Christopher A. Johnson, University of California, Irvine
Jill See, University of California, Irvine
Vicky Chan, University of California, Irvine
Cathy Chou, University of California, Irvine
Wendy Lazouras, University of California, Irvine
Alison L. McKenzie, Chapman UniversityFollow
David J. Reinkensmeyer, University of California, Irvine
Danh V. Nguyen, University of California, Irvine
Steven C. Cramer, University of California, Los Angeles
An H. Do, University of California, Irvine
Zoran Nenadic, University of California, Irvine

Document Type

Article

Publication Date

6-13-2024

Abstract

Background

In the United States, there are over seven million stroke survivors, with many facing gait impairments due to foot drop. This restricts their community ambulation and hinders functional independence, leading to several long-term health complications. Despite the best available physical therapy, gait function is incompletely recovered, and this occurs mainly during the acute phase post-stroke. Therapeutic options are limited currently. Novel therapies based on neurobiological principles have the potential to lead to long-term functional improvements. The Brain-Computer Interface (BCI) controlled Functional Electrical Stimulation (FES) system is one such strategy. It is based on Hebbian principles and has shown promise in early feasibility studies. The current study describes the BCI-FES clinical trial, which examines the safety and efficacy of this system, compared to conventional physical therapy (PT), to improve gait velocity for those with chronic gait impairment post-stroke. The trial also aims to find other secondary factors that may impact or accompany these improvements and establish the potential of Hebbian-based rehabilitation therapies.

Methods

This Phase II clinical trial is a two-arm, randomized, controlled, longitudinal study with 66 stroke participants in the chronic (> 6 months) stage of gait impairment. The participants undergo either BCI-FES paired with PT or dose-matched PT sessions (three times weekly for four weeks). The primary outcome is gait velocity (10-meter walk test), and secondary outcomes include gait endurance, range of motion, strength, sensation, quality of life, and neurophysiological biomarkers. These measures are acquired longitudinally.

Discussion

BCI-FES holds promise for gait velocity improvements in stroke patients. This clinical trial will evaluate the safety and efficacy of BCI-FES therapy when compared to dose-matched conventional therapy. The success of this trial will inform the potential utility of a Phase III efficacy trial.

Trial registration

The trial was registered as ”BCI-FES Therapy for Stroke Rehabilitation” on February 19, 2020, at clinicaltrials.gov with the identifier NCT04279067.

Comments

This article was originally published in BMC Neurology, volume 24, in 2024. https://doi.org/10.1186/s12883-024-03710-3

Recommended Citation

Biswas, P., Dodakian, L., Wang, P.T. et al. A single-center, assessor-blinded, randomized controlled clinical trial to test the safety and efficacy of a novel brain-computer interface controlled functional electrical stimulation (BCI-FES) intervention for gait rehabilitation in the chronic stroke population. BMC Neurol 24, 200 (2024). https://doi.org/10.1186/s12883-024-03710-3

Peer Reviewed

1

Copyright

The authors

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 License.