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

NCT07768930 | Active Not Recruiting

• 1 other identifier: 79344824.8.0000.0129
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Spinal Cord Injury

Keywords

Spinal Cord Injury; Functional Electrical Stimulation; Brain-Computer Interface; Rehabilitation; Foot Ankle Dorsi- flexion

Outcome Measures

Primary Outcomes (2)

• International Standards for Neurological Classification of Spinal Cord Injury

  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

  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 Outcomes (5)

• Electroencephalography Analysis

  Baseline (before start of the intervention); At 24 week after baseline.

• System Usability Scale

  At 24 week after baseline.

• World Health Organization Quality of Life

  Baseline (before start of the intervention); At 12 week after baseline; At 24 week after baseline

• Task Load Index

  At 24 week after baseline

• Intrinsic Motivation Inventory

  At 24 week after baseline.

Other Outcomes (3)

• Douleur Neuropathique 4 questionnaire

  Baseline (before start of the intervention).

• Kinesthetic and Visual Imagery Questionnaire-10

  Baseline (before start of the intervention).

• Modified Ashworth Scale (MAS)

  Baseline (before start of the intervention).

Study Arms (1)

Spinal Cord Injury

EXPERIMENTAL

Other: Ankle Dorsiflexion Rehabilitation

Interventions

Ankle Dorsiflexion Rehabilitation OTHER

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).

Also known as: Motor imagery, Brain - Computer Interface, Neurofeedback, Functional electrical stimulation

Spinal Cord Injury

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Santos Dumont Institute: lead
• Coordination for the Improvement of Higher Education Personnel: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Santos Dumont Institute

Macaíba, Rio Grande do Norte, 59288-999, Brazil

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Brain-Computer Interfaces; Neurofeedback

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies; Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 17, 2026
• Study Start: November 1, 2024
• Primary Completion: November 30, 2025
• Study Completion (Estimated): December 6, 2026
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)