CEUS For Intraoperative Spinal Cord Injury

Not Applicable

Active, not recruiting

• Conditions: Spine Disease; Spinal Cord Injuries; Spinal Cord Compression; Spinal Stenosis; Spinal Injury; Spine Degeneration; Spinal Cord Diseases
• Interventions: Device: Definity Perflutren Lipid Microsphere Ultrasound Contrast

• Registration Number: NCT05530798
• Lead Sponsor: Medical University of South Carolina

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-30
• Study First Submitted QC: 2022-09-06
• Study First Posted: 2022-09-07
• Study Start: 2023-12-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Contrast Enhanced Ultrasound Arm	Definity Perflutren Lipid Microsphere Ultrasound Contrast	-

Primary Outcome Measures

Name	Time	Method
Contrast Enhanced Ultrasound to determine changes of blood flow in the spinal cord at the site of decompression.	Intra-operative (Approximately 3 hours)	Use of Contrast Enhanced ultrasound to identify discreet areas of perfusion changes in the spinal cord of subjects that undergo spinal cord decompression.

Secondary Outcome Measures

Name	Time	Method
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).	Clinical Monitoring (12 months)	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

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States