CEUS For Intraoperative Spinal Cord Injury

NCT05530798 | Completed DMC FDA Device

• 1 other identifier: 00120959
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Contrast Enhanced Ultrasound; CEUS

Outcome Measures

Primary Outcomes (1)

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

  Use of Contrast Enhanced ultrasound to identify discreet areas of perfusion changes in the spinal cord of subjects that undergo spinal cord decompression.

  Intra-operative (Approximately 3 hours)

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).

  Clinical Monitoring (12 months)

Study Arms (1)

Contrast Enhanced Ultrasound Arm

EXPERIMENTAL

Device: Definity Perflutren Lipid Microsphere Ultrasound Contrast

Interventions

Definity Perflutren Lipid Microsphere Ultrasound Contrast 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.

Contrast Enhanced Ultrasound Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients consented and scheduled for posterior cervicothoracic decompression surgery with the PI for the diagnosis of cervicothoracic myeloradiculopathy
• Age 18-80

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• South Carolina Spinal Cord Injury Research Fund: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Spinal Diseases; Spinal Stenosis; Spinal Injuries; Spinal Cord Diseases; Spinal Cord Injuries; Spinal Cord Compression

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Back Injuries; Wounds and Injuries; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Faculty

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 7, 2022
• Study Start: December 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 27, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)