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CEUS For Intraoperative Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05530798
Recruitment Status : Not yet recruiting
First Posted : September 7, 2022
Last Update Posted : September 7, 2022
Sponsor:
Collaborator:
South Carolina Spinal Cord Injury Research Fund
Information provided by (Responsible Party):
Bruce M. Frankel, Medical University of South Carolina

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Spine Disease Spinal Stenosis Spinal Injury Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Compression Spine Degeneration Device: Definity Perflutren Lipid Microsphere Ultrasound Contrast Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Contrast Enhanced Ultrasound for The Evaluation of Intraoperative Spinal Cord Injury Following Surgical Decompression of a Chronically Compressed Spinal Cord
Estimated Study Start Date : October 1, 2022
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05530798


Contacts
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Contact: Brian F Saway, MD 8434940234 saway@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Contact: Brian Saway, MD    843-494-0234    saway@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
South Carolina Spinal Cord Injury Research Fund
Investigators
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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
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Bruce M. Frankel, Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT05530798    
Other Study ID Numbers: 00120959
First Posted: September 7, 2022    Key Record Dates
Last Update Posted: September 7, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Bruce M. Frankel, Medical University of South Carolina:
Contrast Enhanced Ultrasound
CEUS
Additional relevant MeSH terms:
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Spinal Stenosis
Spinal Diseases
Spinal Cord Injuries
Spinal Cord Compression
Spinal Cord Diseases
Wounds and Injuries
Spinal Injuries
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Bone Diseases
Musculoskeletal Diseases
Back Injuries