BCI-Guided Tibialis Anterior FES for Gait Training in Spinal Cord Injury

August 12, 2026 updated by: Caroline Cunha, Santos Dumont Institute

Use of Brain Interface-Guided Functional Electrical Stimulation - Gait Training Machine in Individuals With Spinal Cord Injury

This study aims to investigate the effectiveness of Brain-Computer Interface (BCI)-guided Functional Electrical Stimulation (FES) in improving muscle activation and gait kinematics in individuals with Spinal Cord Injury (SCI).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Introduction:

Spinal Cord Injury (SCI) causes serious motor and sensory deficits, affecting thousands of people globally. Brain-Computer Interface (BCI) combined with Functional Electrical Stimulation (FES) emerges as a promising strategy to rehabilitate individuals with SCI. This mechanism will simultaneously stimulate the affected regions of the lower limbs, causing the compromised muscles to contract, causing movement. The FES technique, with its proven effectiveness in improving muscle strength, stands out as a crucial resource in this process of improving approaches integrated with advanced technology and physiotherapeutic principles to offer a promising perspective in neuromuscular rehabilitation.

Objective:

This study aims to investigate the effectiveness of Brain-Computer Interface (BCI)-guided Functional Electrical Stimulation (FES) in improving muscle activation and gait kinematics in individuals with Spinal Cord Injury (SCI).

Methodology:

This is a quasi-experimental study that will be conducted with four (n=4) volunteers with Spinal Cord Injury (age range: 18-60 years), of both sexes. Data collection will take place at the Edmond and Lily Safra International Institute of Neurosciences (IIN-ELS), Macaíba/RN, Brazil. For the characterization and eligibility of volunteers, the following instruments will be used: Modified Ashworth Scale, Douleur Neuropathique 4 questionnaire (DN4), and the Visual-10, Kinesthetic and Visual Imagery Questionnaire-10 (KVIQ-10). For clinical outcomes, the American Spinal Injury Association (ASIA), Spinal Cord Independence Measure - version III (SCIM-III), and the World Health Organization Quality of Life (WHOQOL-BREF) will be used. At the end of the protocol, the following questionnaires will be administered: System Usability Scale (SUS), Intrinsic Motivation Inventory (IMI), and Task Load Index (NASA-TLX) to assess system usability, intrinsic motivation, and perceived workload. The intervention will consist of 24 sessions aiming to use a brain-computer interface based on kinesthetic motor imagery of dorsiflexion associated with neurofeedback (visual and tactile), focused on the functional outcomes of individuals with paraplegia. During the intervention, volunteers will be instructed to imagine performing the dorsiflexion movement. An electroencephalogram (EEG) will be used to monitor brain activity through sensorimotor rhythms. When activity reaches a minimum threshold, functional electrical stimulation (FES) will be triggered, causing contraction of the tibialis anterior muscle.

Expected Results:

It is expected that BCI-guided FES targeting tibialis anterior muscle activation in individuals with SCI will contribute to the rehabilitation process by promoting improvements in neurological function, functional independence, and cortical activity. Changes are expected in clinical outcomes assessed by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI/ASIA) and the Spinal Cord Independence Measure III (SCIM III), as well as in EEG patterns associated with sensorimotor cortical activation. Furthermore, this innovative approach will not only provide improvements in the physical performance of individuals with SCI, but will also contribute to the continuous evolution of rehabilitation strategies, highlighting the fundamental role of technological advances in promoting the quality of life and autonomy of these individuals.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do Norte
      • Macaíba, Rio Grande do Norte, Brazil, 59288-999
        • Santos Dumont Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinical diagnosis of traumatic spinal cord injury (SCI), classified as AIS grades A to D
  • Male or female participants
  • Age between 18 and 60 years

Exclusion Criteria:

  • Skin lesions that preclude the use of functional electrical stimulation (FES)
  • Lower-limb contractures that preclude the use of FES
  • Lower-limb spasticity that precludes the use of FES
  • Osteoporosis
  • Recent surgical procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Spinal Cord Injury
Other: Ankle Dorsiflexion Rehabilitation

The intervention protocol will last 26 min. The first 2 min are used to collect EEG data under baseline conditions, during which the participant does not perform mental tasks or receive electrical stimulation. Then there is 6 min of motor training with Neurofeedback (NFB). During this time, two 10s periods: one in which the FES devices are activated without motor imagery (MI), and another in which the FES is activated by the MI to induce movements in the feet. This includes six separate attempts for the right foot, left foot, and both feet, for a total of 18 attempts. After completing the NFB phase, the participant rests for 6 min to avoid mental and muscular fatigue.

Subsequently, the user performs 12 min of training with BCI. This involves 20s intervals of MI to trigger the FES devices to dorsiflex the feet, followed by 20s rest periods. This cycle is repeated for a total of 18 exercises, six for each movement (right foot, left foot and both feet).

Other Names:
  • Neurofeedback
  • Motor imagery
  • Brain - Computer Interface
  • Functional electrical stimulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
International Standards for Neurological Classification of Spinal Cord Injury
Time Frame: Baseline (before start of the intervention) At 12 week after baseline At 24 week after baseline
The International Standards for Neurological Classification of Spinal Cord Injury/ASIA will be used to assess the neurological level and severity of spinal cord injury, including motor and sensory function. The sensory score ranges from 0 (absent) to 2 (normal). The ASIA sensory scores for light touch and pinprick are calculated by summing the scores across 28 dermatomes, with a total score ranging from 0 to 112 for each modality. Higher scores indicate better sensory function. Motor function will be assessed bilaterally using the 10 key muscles corresponding to the C5-T1 and L2-S1 myotomes. Muscle strength is graded from 0 (total paralysis) to 5 (normal movement against maximum resistance). The ASIA Lower Extremity Motor Score (LEMS; range 0-50) will be used to assess lower-extremity motor function, with higher scores indicating better motor function.
Baseline (before start of the intervention) At 12 week after baseline At 24 week after baseline
Spinal Cord Independence Measure III
Time Frame: Baseline (before start of the intervention) At 12 week after baseline At 24 week after baseline
To assess functional independence in individuals with spinal cord injury. The instrument evaluates self-care, respiration and sphincter management, and mobility. The total Spinal Cord Independence Measure III score ranges from 0 to 100, with higher scores indicating greater levels of independence.
Baseline (before start of the intervention) At 12 week after baseline At 24 week after baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Electroencephalography Analysis
Time Frame: Baseline (before start of the intervention); At 24 week after baseline.
Verify the clinical effects and cortical activity of mu and beta rhythms through electroencephalography analysis. Power Spectral Density (PSD) will be estimated using Welch's periodogram. Mean power will be calculated across trials for the mu (8-12 Hz) and beta (18-24 Hz) frequency bands. Power values will then be normalized to the mean power across the 8-30 Hz passband. The percentage change in power during kinesthetic motor imagery relative to the resting condition will then be calculated.
Baseline (before start of the intervention); At 24 week after baseline.
System Usability Scale
Time Frame: At 24 week after baseline.
To evaluate participants' perception and satisfaction in relation to the intervention protocol, using the System Usability Scale questionnaire, with the aim of identifying the most relevant and impactful aspects of the intervention for volunteers with SCI. The final score ranges from 0 to 100, with scores above 68 indicating good system usability.
At 24 week after baseline.
World Health Organization Quality of Life
Time Frame: Baseline (before start of the intervention); At 12 week after baseline; At 24 week after baseline
The World Health Organization Quality of Life-BREF will be used to assess participants' perceived quality of life. The questionnaire evaluates four domains: physical health, psychological health, social relationships, and environment. The raw domain score will be converted into a standardized score, ranging from 0 to 100, with a higher score indicating a better perceived quality of life.
Baseline (before start of the intervention); At 12 week after baseline; At 24 week after baseline
Task Load Index
Time Frame: At 24 week after baseline
The Task Load Index will be used to assess participants' perceived workload during the intervention. The questionnaire evaluates six dimensions: mental demand, physical demand, temporal demand, performance, effort, and frustration. The sum of the weighted mean scores across these dimensions results in a total perceived workload score ranging from 0 to 100, classified as very low (0-20), low (21-40), moderate (41-60), high (61-80), and very high (81-100). Higher scores indicate greater perceived workload.
At 24 week after baseline
Intrinsic Motivation Inventory
Time Frame: At 24 week after baseline.
It consists of 10 items rated on a 7-point Likert scale, ranging from 1 to 7, with higher scores indicating greater motivation and reflecting the level of agreement or satisfaction regarding different aspects of the motivational experience. The domains assessed include interest/enjoyment, effort/importance, and value/usefulness.
At 24 week after baseline.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Douleur Neuropathique 4 questionnaire
Time Frame: Baseline (before start of the intervention).
To identify the presence of neuropathic pain. The score ranges from 0 to 10, with scores ≥4 indicating the presence of neuropathic pain. For the eligibility criteria.
Baseline (before start of the intervention).
Kinesthetic and Visual Imagery Questionnaire-10
Time Frame: Baseline (before start of the intervention).
To assess the volunteer's ability to generate and manipulate mental images. The questionnaire score ranges from 0 to 25, with higher scores indicating greater motor imagery ability.. For the eligibility criteria.
Baseline (before start of the intervention).
Modified Ashworth Scale (MAS)
Time Frame: Baseline (before start of the intervention).
To assess muscle spasticity, with scores ranging from 0 to 4, where 0 indicates no increase in muscle tone and 4 indicates severe spasticity, for eligibility assessment.
Baseline (before start of the intervention).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Santos Dumont Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Coordination for the Improvement of Higher Education Personnel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 6, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 79344824.8.0000.0129

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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