Near-Infrared Imaging of Motor Imagery Effects in Spinal Cord Injury

NCT07106060 | Recruiting

• 1 other identifier: 2025PS450K
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this clinical trial is to investigate the efficacy of motor imagery-based brain-computer interface (MI-BCI) technology in improving motor function among patients with spinal cord injury (SCI), as well as its impact on cortical motor area function across varying states. To achieve this, the study will implement MI-BCI intervention in SCI patients, evaluate post-treatment motor function improvements, and assess changes in cortical motor area oxygen metabolism (via functional near-infrared spectroscopy, fNIRS) and neural activity (via electroencephalography, EEG). The ultimate goal is to establish a novel rehabilitation strategy for SCI. Specifically, the trial aims to: (1) determine whether MI-BCI effectively enhances motor function in SCI patients; and (2) clarify the differential effects of MI-BCI on cortical motor area function under distinct states (e.g., resting vs. task-performing) in this population. Participants will be randomly assigned to one of two groups: the experimental group will undergo MI-BCI training, while the control group will receive active cycling training (as a conventional rehabilitation control). Both interventions will be structured as 20-minute sessions, administered 5 days per week, over a total of 4 weeks.Pre- and post-treatment assessments will include: lower limb motor function (measured by the Lower Limb Motor Score), activities of daily living (evaluated via the Modified Barthel Index), walking capacity (quantified using the Spinal Cord Injury Walking Index), and cortical motor activity (captured through fNIRS and EEG measurements).

Conditions

SCI - Spinal Cord Injury; Motor Imagery; Brain-Computer Interfaces

Keywords

SCI - Spinal Cord Injury; motor imagery; Brain-Computer Interfaces; Functional near-infrared spectroscopy

Outcome Measures

Primary Outcomes (1)

• The ASIA Impairment Scale (AIS) assesses lower limb motor function

  The ASIA Impairment Scale (AIS) assesses lower limb motor function in patients with spinal cord injury (SCI) by evaluating muscle strength in 6 key muscle groups innervated by the L2-S1 spinal segments (3 per limb: iliopsoas, quadriceps femoris, tibialis anterior, extensor hallucis longus, gastrocnemius-soleus, and gluteus maximus). Using the Medical Research Council (MRC) 0-5 grading system (0: no contraction; 5: normal strength), examiners observe active movement capabilities under standardized positions (supine/prone), scoring after excluding compensatory movements. The unilateral lower limb total score ranges from 0 to 30, with a bilateral total score of 0-60, serving as a component of the AIS total motor score (0-100) for rehabilitation outcome evaluation.

  Baseline, 4-weeks treatment

Secondary Outcomes (1)

• The Modified Barthel Index (MBI)

  Baseline, 4-weeks treatment

Study Arms (2)

MI-BCI training

EXPERIMENTAL

Participants will use an EEG-based rehabilitation training device (L-B300). After wearing an EEG cap and lying supine, their lower limbs will be positioned on a pedal with the hip, knee, and ankle joints of the unaffected (stronger) leg maintained at 90°. The leg support will be adjusted to the mid-calf and secured with straps. Participants will be instructed to focus on a screen and perform MI training. If they fail to activate the device within 30 seconds under guidance, the EEG difficulty level will be reduced until successful activation within 30 seconds. The EEG difficulty level will be adjusted throughout the trial based on the participant's MI ability.

Device: EEG-based rehabilitation training device (L-B300)

Cycling training

ACTIVE COMPARATOR

Participants will lie supine, with their lower limbs fixed to the L-B300 device using the same method as Group A. The computer screen will be turned off, and the machine will be set to drive passive or active cycling movements of the lower limbs. Both groups will undergo 20-minute sessions, 5 days/week, for 4 weeks (total of 20 sessions).

Device: EEG-based rehabilitation training device (L-B300)（Not connected）

Interventions

EEG-based rehabilitation training device (L-B300) DEVICE

Participants will use an EEG-based rehabilitation training device (L-B300). After wearing an EEG cap and lying supine, their lower limbs will be positioned on a pedal with the hip, knee, and ankle joints of the unaffected (stronger) leg maintained at 90°. The leg support will be adjusted to the mid-calf and secured with straps. Participants will be instructed to focus on a screen and perform MI training. If they fail to activate the device within 30 seconds under guidance, the EEG difficulty level will be reduced until successful activation within 30 seconds. The EEG difficulty level will be adjusted throughout the trial based on the participant's MI ability.

MI-BCI training

EEG-based rehabilitation training device (L-B300)（Not connected） DEVICE

Participants will lie supine, with their lower limbs fixed to the L-B300 device using the same method as Group A. The computer screen will be turned off, and the machine will be set to drive passive or active cycling movements of the lower limbs.

Cycling training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The vital signs are stable and the spine is stable, making the subject suitable for exercise testing.
• Patients with spinal cord injury (SCI) who meet the international diagnostic criteria for SCI neurology revised by the American SCI Society in 2019 and have been diagnosed by CT or MRI.
• The injury level of SCI is C5-T12, and the ASIA grade is A-C.
• The course of the disease is ≤12 months (but the spinal shock period must have passed).
• Age: 18-75 years old, regardless of gender.
• Good cognitive function, able to understand and actively participate in the training program, and willing to sign the informed consent form for this clinical study.

You may not qualify if:

• Those with tumors, tuberculosis, hematologic diseases, or dysfunction of important organs such as the heart and liver;
• Those with unstable fractures;
• Those with severe abnormal limb muscle tone and joint contracture deformities;
• Those with severe pain that cannot tolerate activities;
• Those with severe emotional problems who cannot cooperate to complete the study.

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Rehabilitation Center of Shengjing Hospital, China Medical University

Shenyang, Liaoning, China

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Xue Jiang

  Shengjing Hospital

  STUDY CHAIR

Central Study Contacts

Xue Jiang

CONTACT

+8618940254064; jiangxueruby@163.com

He Xiao Gao

CONTACT

+8615004007015

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 6, 2025
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: After publication under reasonable request.

Locations

CN (1)