spinal cord injury
Conditions
Interventions
Control group:Standard Cycling Training Group
Experimental group:Brain-Computer Interface Cycling Training Group
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Vital signs are stable, and the subject can tolerate 20 minutes of MI-BCI cycling training. 2.Age: 18–75 years old, no gender restrictions; 3.Traumatic spinal cord injury (including surgical trauma) meeting the criteria of the International Diagnostic Classification of Spinal Cord Injury revised by the American Spinal Injury Association in 2019 and confirmed by CT or MRI. 4.The motor level of spinal cord nerve injury is C5-T12, with spinal cord injury classification at Grade B or C. 5.The patient has been ill for >=2 weeks and has been assessed by the research physician as having passed the acute critical phase. Vital signs and spinal condition are stable, and the patient can safely tolerate training. 6.Cognitive function is intact, enabling the subject to understand and actively participate in the training program, and to consent to and sign this clinical research informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with severe comorbidities such as deep vein thrombosis in the lower extremities, extremely high-risk hypertension, unstable coronary artery disease, or life-threatening osteoporosis that prevent them from completing the full course of training. 2.Patients with severe anxiety and depressive symptoms (SAS score >50, SDS score >70); 3.Limited range of motion in the lower limbs or restricted flexion and extension movements due to other factors; 4.Improved muscle tone in both lower limbs, Ashworth scale > Grade 2; 5.Conditions unsuitable for wearable devices, such as scalp and skull injuries, lower limb skin injuries, or infections that prevent device wear. 6.Researchers determined that patients had poor compliance or did not understand the trial, making it impossible for them to complete the study as required. 7.Participated in other drug or medical device clinical trials during the same period. 8.Other circumstances deemed ineligible for inclusion by the researchers;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lower extremity motor function score for spinal cord injury; | — |
Secondary
| Measure | Time frame |
|---|---|
| Continuous motion state transition time, motion state percentage, and effective training revolutions;Diffusion tensor imaging,DTI;Walking index for spinal cord injury;Modified ashworth scale;Spinal cord independence measure ?;Spinal Cord Injury Sensory Function Score;Surface Electromyography Assessment of the Lower Extremities;Task-based functional magnetic resonance imaging,fMRI;Transcranial magnetic stimulation-motor evoked potentials,TMS-MEP;Adverse events; | — |
Countries
China
Contacts
Public ContactYongqiang Li
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed