CEUS For Intraoperative Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05530798
• Other study ID #: 00120959
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: January 2024
• Source: Medical University of South Carolina
• Contact: Brian F Saway, MD
• Phone: 8434940234
• Email: saway[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients consented and scheduled for posterior cervicothoracic decompression surgery with the PI for the diagnosis of cervicothoracic myeloradiculopathy

• Age 18-80

Exclusion Criteria:

• Pregnancy

• Patient's with known hypersensitivity to ultrasound contrast

• Patients with known hypersensitivity to perflutren lipid microsphere or its components, such as polyethylene glycol (PEG)

• Patients unable to actively participate in the consent process physically and/or cognitively

• Prior decompression at the intended level of decompression

Related Conditions & MeSH terms

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

Intervention

Device:
• Definity Perflutren Lipid Microsphere Ultrasound Contrast
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. 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. Prior to completion and closure of the incision, the study team will once more inject the ultrasound contrast to visualize the spinal cord. 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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	South Carolina Spinal Cord Injury Research Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast Enhanced Ultrasound to determine changes of blood flow in the spinal cord at the site of decompression.	Use of Contrast Enhanced ultrasound to identify discreet areas of perfusion changes in the spinal cord of subjects that undergo spinal cord decompression.	Intra-operative (Approximately 3 hours)
Secondary	Correlation of perfusion changes measured by intra-operative Contrast Enhanced Ultrasound with neurologic outcomes measured by serial neurologic exams and functional outcomes (Frankel Grade and Modified Rankin Scale).	To assess whether discreet areas of perfusion changes seen by Contrast Enhanced ultrasound in the spinal cord intraoperatively correlate with the neurologic and functional outcomes of subjects that undergo spinal cord decompression	Clinical Monitoring (12 months)