CEUS For Intraoperative Spinal Cord Injury

NCT ID: NCT05530798

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2025-08-01

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Contrast Enhanced Ultrasound Arm

Group Type: EXPERIMENTAL

Definity Perflutren Lipid Microsphere Ultrasound Contrast

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South Carolina Spinal Cord Injury Research Fund

UNKNOWN

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Stephen Kalhorn

Professor-Faculty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian F Saway, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Stephen Kalhorn, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Jessica Barley, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

00120959

Identifier Type: -

Identifier Source: org_study_id