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

NCT07106060 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-08-06

No results posted yet for this study

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

Interventions

DEVICE

EEG-based rehabilitation training device (L-B300)

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)（Not connected）

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.

Sponsors & Collaborators

  • Shengjing Hospital

    lead OTHER

Principal Investigators

  • Xue Jiang · Shengjing Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-01-01
Completion
2026-02-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07106060 on ClinicalTrials.gov