NCT07106060 Near-Infrared Imaging of Motor Imagery Effects in Spinal Cord Injury
| NCT ID | NCT07106060 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shengjing Hospital |
| Condition | SCI - Spinal Cord Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2025-01-01 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
Inclusion Criteria: 1. The vital signs are stable and the spine is stable, making the subject suitable for exercise testing. 2. 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. 3. The injury level of SCI is C5-T12, and the ASIA grade is A-C. 4. The course of the disease is ≤12 months (but the spinal shock period must have passed). 5. Age: 18-75 years old, regardless of gender. 6. 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. Exclusion Criteria: 1. Those with tumors, tuberculosis, hematologic diseases, or dysfunction of important organs such as the heart and liver; 2. Those with unstable fractures; 3. Those with severe abnormal limb muscle tone and joint contracture deformities; 4. Those with severe pain that cannot tolerate activities; 5. Those with severe emotional problems who cannot cooperate to complete the study.
Contact & Investigator
Xue Jiang
STUDY CHAIR
Shengjing Hospital
Frequently Asked Questions
Who can join the NCT07106060 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying SCI - Spinal Cord Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07106060 currently recruiting?
Yes, NCT07106060 is actively recruiting participants. Contact the research team at jiangxueruby@163.com for enrollment information.
Where is the NCT07106060 trial being conducted?
This trial is being conducted at Shenyang, China.
Who is sponsoring the NCT07106060 clinical trial?
NCT07106060 is sponsored by Shengjing Hospital. The principal investigator is Xue Jiang at Shengjing Hospital. The trial plans to enroll 36 participants.