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Exploration of multimodal mechanisms after cervical spinal cord injury: A longitudinal prospective observational study of preoperative diffusion tensor imaging, intraoperative non-invasive spinal cord tissue oxygen monitoring and postoperative functional magnetic resonance imaging - An independent add-on study nested within the DISCUS randomized controlled trial

Exploration of multimodal mechanisms after cervical spinal cord injury: A longitudinal prospective observational study of preoperative diffusion tensor imaging, intraoperative non-invasive spinal cord tissue oxygen monitoring and postoperative functional magnetic resonance imaging - An independent add-on study nested within the DISCUS randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600127814
Enrollment
Unknown
Registered
2026-07-08
Start date
2026-07-15
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Spinal Cord Injury

Interventions

DISCUS-Laminectomy Group:None
DISCUS-Duroplasty Group:None

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

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

MeasureTime 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

MeasureTime 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

Public ContactGuo Xiaodong

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

xiaodongguo@hust.edu.cn+86 27 85726524

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026