Evidence map›Paper›PMID 38872109›Full record

Trial reportBMC neurology2024

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.

Piyashi Biswas, Lucy Dodakian, Po T Wang, Christopher A Johnson, Jill See, Vicky Chan, Cathy Chou, Wendy Lazouras, Alison L McKenzie, David J Reinkensmeyer and 4 more

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC neurology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04279067 (Brain Computer Interface - Functional Electrical Stimulation), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04279067 nacompletednot on this map

Brain Computer Interface - Functional Electrical Stimulation (BCI-FES) Therapy for Stroke Rehabilitation

TypeinterventionalSponsorUniversity of California, IrvineRan2020 to 2024Enrolled62ConditionsIschemic Stroke, Hemorrhagic StrokeArmsBCI-FES dorsiflexion therapy, Physiotherapy one hour, Physiotherapy two hours
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Functional Electrical Stimulation and Stroke Rehabilitation Research: The Critical Role of Sham Control Groups.Physiotherapy research international : the journal for researchers and clinicians in physical therapy · 2026
    Article
  2. Review of Recent Advances in Implantable Brain-Computer Interfaces for the Restoration of Motor Function in Patients With Paralysis.Medical science monitor : international medical journal of experimental and clinical research · 2026
    Review
  3. Review
  4. Brain-computer interface: an update for the clinicians.Frontiers in human neuroscience · 2026
    Review
  5. Article
  6. Article
  7. Brain-Computer Interfaces for Stroke Motor Rehabilitation.Bioengineering (Basel, Switzerland) · 2025
    Review
  8. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Piyashi BiswasDepartment of Biomedical Engineering, University of California, Irvine, USA.
Lucy DodakianDepartment of Rehabilitation Services, University of California at Irvine Medical Center, Orange, USA.
Po T WangDepartment of Biomedical Engineering, University of California, Irvine, USA.
Christopher A JohnsonDepartment of Biomedical Engineering, University of California, Irvine, USA.
Jill SeeDepartment of Rehabilitation Services, University of California at Irvine Medical Center, Orange, USA.
Vicky ChanDepartment of Rehabilitation Services, University of California at Irvine Medical Center, Orange, USA.
Cathy ChouDepartment of Rehabilitation Services, University of California at Irvine Medical Center, Orange, USA.
Wendy LazourasDepartment of Rehabilitation Services, University of California at Irvine Medical Center, Orange, USA.
Alison L McKenzieDepartment of Neurology, University of California, Irvine, USA.
David J ReinkensmeyerDepartment of Anatomy and Neurobiology, University of California, Irvine, USA.
Danh V NguyenDepartment of General Internal Medicine, University of California, Irvine, USA.
Steven C CramerDepartment of Neurology, University of California, Los Angeles, USA.
An H DoDepartment of Neurology, University of California, Irvine, USA. and@hs.uci.edu.
Zoran NenadicDepartment of Biomedical Engineering, University of California, Irvine, USA. znenadic@uci.edu.

Funding

University of California Health Participation in the National COVID Cohort Collaborative (N3C)UL1TR001414 · NCATS · UNIVERSITY OF CALIFORNIA-IRVINE · PI COOPER, DAN M, VILAIN, ERIC J. · 2015 to 2023
$35.1M
National Institutes of Health, United States 5R01HD095457NCATS NIH HHS UL1 TR001414
6 · The paper itself

Abstract

backgroundIn 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.

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

Indexed as

Brain-Computer InterfacesElectric Stimulation TherapyGait Disorders, NeurologicStroke RehabilitationAdultAgedChronic DiseaseFemaleGaitHumansMaleMiddle AgedSingle-Blind MethodStrokeTreatment OutcomeBrain-computer interfaceBrain plasticityElectroencephalographyFunctional electrical stimulationGait velocityLower extremity rehabilitationMotor learningNeurorehabilitationStroke

Identifiers

PMID38872109
PMCPMC11170800

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.