Skip to main content
OpenTrials
Completed

NCT Number: NCT05530798

CEUS For Intraoperative Spinal Cord Injury

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Definity Perflutren Lipid Microsphere Ultrasound Contrast

Device
  • 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.

Primary outcomes

  1. Contrast Enhanced Ultrasound to determine changes of blood flow in the spinal cord at the site of decompression.

    Time frame: 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • South Carolina Spinal Cord Injury Research Fund

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 7, 2022
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.