CEUS For Intraoperative Spinal Cord Injury

August 15, 2026 updated by: Stephen Kalhorn, Medical University of South Carolina

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Contrast Enhanced Ultrasound Arm
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in Spinal Cord Contrast-Enhanced Ultrasound Signal Intensity Before and After Surgical Decompression
Time Frame: Intra-operative (approximately 3 hours)
Contrast-enhanced ultrasound (CEUS) images were obtained intraoperatively before and after spinal cord decompression. Signal intensity (echogenicity) within the spinal cord at the decompressed segment was quantified from CEUS images and measured in dB/MHz/cm. The outcome measure was the change in signal intensity from pre-decompression imaging to post-decompression imaging. A positive value indicates increased perfusion signal following decompression, while a negative value indicates decreased perfusion signal.
Intra-operative (approximately 3 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Time Frame: 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
Clinical Monitoring (12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

South Carolina Spinal Cord Injury Research Fund

Investigators

  • Principal Investigator: Brian F Saway, MD, Medical University of South Carolina
  • Principal Investigator: Stephen Kalhorn, MD, Medical University of South Carolina
  • Principal Investigator: Jessica Barley, PhD, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

August 1, 2025

Study Completion (Actual)

August 1, 2025

Study Registration Dates

First Submitted

August 30, 2022

First Submitted That Met QC Criteria

September 6, 2022

First Posted (Actual)

September 7, 2022

Study Record Updates

Last Update Posted (Actual)

September 4, 2026

Last Update Submitted That Met QC Criteria

August 15, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00120959

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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