CEUS For Intraoperative Spinal Cord Injury

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Spinal Cord Injuries; Spine Disease; Spinal Stenosis; Spine Degeneration; Spinal Cord Compression; Spinal Cord Diseases; Spinal Injury

Treatments: Device: Definity Perflutren Lipid Microsphere Ultrasound Contrast

Study type: Interventional

Funder types: Other

Identifiers

NCT05530798

00120959

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Contrast Enhanced Ultrasound Arm

Experimental group

Treatment:

Device: Definity Perflutren Lipid Microsphere Ultrasound Contrast