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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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).

Eligibility

Primary outcome measure(s)

• The ASIA Impairment Scale (AIS) assesses lower limb motor function — Baseline, 4-weeks treatment
  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.

Trial sites (1)

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