Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT07106060

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

Led by Shengjing Hospital · Updated on 2025-08-06

36

Participants Needed

1

Research Sites

56 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Stable vital signs and spine suitable for exercise testing
  • Diagnosed spinal cord injury meeting 2019 American SCI Society criteria, confirmed by CT or MRI
  • Injury level between C5 and T12 with ASIA grade A to C
  • Injury duration of 12 months or less, with spinal shock period passed
  • Age between 18 and 75 years, any gender
  • Good cognitive function and ability to participate actively, with informed consent signed
Not Eligible

You will not qualify if you...

  • Tumors, tuberculosis, blood diseases, or major organ dysfunction such as heart or liver
  • Unstable fractures
  • Severe abnormal limb muscle tone or joint contractures
  • Severe pain that prevents activity
  • Severe emotional problems preventing study cooperation

AI-Screening

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Trial Site Locations

Total: 1 location

1

Rehabilitation Center of Shengjing Hospital, China Medical University

Shenyang, Liaoning, China

Actively Recruiting

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Research Team

X

Xue Jiang

CONTACT

H

He Xiao Gao

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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