Cervical Spinal Cord Injury
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. Have been successfully enrolled in the DISCUS main trial and have completed randomization; 3. The study participant or their authorized representative is able to sign the informed consent form; 4.No conventional contraindications for MRI examination (Non-MR compatible metal implants, pacemakers, claustrophobia, etc.)(Section One, Three); 5.The condition is stable and can tolerate an additional 15-minute sequence scan time.(Close eyes, stay quiet, but don't fall asleep)(Section One, Three); 6.The surgeon agreed to temporarily (for less than 2 minutes) insert the tissue oxygen probe.(Section Two); 7.Follow the instructions to perform actions such as clenching your fist and extending your fingers.(Section Three);
Exclusion criteria
Exclusion criteria: 1.Does not meet any of the inclusion criteria of the main DISCUS trial; 2.There are any of the exclusion criteria stipulated in the main trial of DISCUS; 3.There are MRI contraindications (Phobia of confined spaces, having non-MR-compatible metal objects inside the body, pacemakers, etc.) (Section One and Three); 4.The condition is unstable and cannot tolerate additional sequence scans (Section One and Three); 5.The surgeon believed that it was not appropriate to place the probe.(Section Two); 6.There have been previous incidents of cerebrovascular accidents (including stroke and cerebral hemorrhage) (Section Three); 7.The brain plain scan examination revealed the presence of an intracranial mass (such as a tumor or hematoma) (Section Three); 8.There is lacunar infarction in the brain tissue of the hand function area. (Section Three); 9.Other situations where the functional MRI cannot be completed (Section Three);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gray matter volume / cortical thickness;Tissue Hemoglobin Index;Quality of fiber bundle tracing imaging;Volume of injured segmental fiber bundles;Change in AIS Motor Score from baseline to 6 months;Fractional Anisotropy;Tissue Oxygenation Index;Apparent Diffusion Coefficient;Functional connectivity strength of the sensorimotor network;Functional connectivity of other brain regions of interest (such as the premotor area and the prefrontal cortex); | — |
Secondary
| Measure | Time frame |
|---|---|
| All secondary clinical outcomes (such as AIS sensory score, CUE-Q, SCIM-III, SF-36, etc.) including the main trial of DISCUS; | — |
Countries
China
Contacts
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology