NCT05530798

CEUS For Intraoperative Spinal Cord Injury

Contrast Enhanced Ultrasound for The Evaluation of Intraoperative Spinal Cord Injury Following Surgical Decompression of a Chronically Compressed Spinal Cord

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Spinal cord injury following posterior decompression in patients suffering from chronic, cervicothoracic spinal cord compression is a known complication with multiple etiologies. Currently, intraoperative neuromonitoring (IONM) remains the gold standard for predicting and preventing post-operative deficits from these procedures. However, there is a paucity in the field of spine surgery for further, non-invasive biomarkers that can help detect and prognosticate the degree of spinal cord injury intraoperatively. Contrast enhanced ultrasound (CEUS) is a radiation free imaging modality that utilizes nanobubble technology to allow for visualization of the macro- and microvascular architecture of soft tissue structures. Despite being currently approved for the use in hepatology and cardiology, it has remained absent from the field of spinal cord injury. The study team aims to evaluate and quantify micro- and macrovascular changes that lead to areas of hyper-perfusion as well as areas of ischemia intraoperatively in patients that undergo elective cervicothoracic posterior decompression for chronic compression. In addition, the study team aims to assess the efficacy of CEUS in detecting microvascular changes that correlate with IONM changes and predicting degree and recovery of post-operative neurologic deficits from intraoperative spinal cord injury. The study team hypothesizes that following decompression, subjects will have detectable levels of microvascular changes causing areas of hypoperfusion and reperfusion injury. Second, the study team hypothesizes that these perfusion changes will correlate with intraoperative neuromonitoring changes and can predict and prognosticate the degree of post-operative neurologic injury.

Conditions

• Spine Disease
• Spinal Stenosis
• Spinal Injury
• Spinal Cord Diseases
• Spinal Cord Injuries
• Spinal Cord Compression
• Spine Degeneration

Interventions

Type	Name	Description
DEVICE	Definity Perflutren Lipid Microsphere Ultrasound Contrast	1. Before the spinal decompression surgery has started, the study team will inject the ultrasound contrast to visualize the spinal cord prior to decompression of the spinal cord. 2. After the spinal cord has been decompressed, the study team will inject the ultrasound contrast to visualize the spinal cord directly after decompression of the spinal cord. 3. Prior to completion and closure of the incision, the study team will once more inject the ultrasound contrast to visualize the spinal cord. 4. A member of the research team will follow up with study participants within a week of the procedure by phone. The research staff will also review the participants' medical record for up to 360 days after your procedure to collect information on clinical outcomes and any additional treatments, tests or procedures the study participants may have had.

Timeline

• Start date: 2023-12-01
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2022-09-07
• Last updated: 2025-08-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study