Clinical trial NCT05530798: CEUS For Intraoperative Spinal Cord Injury
Official title: Contrast Enhanced Ultrasound for The Evaluation of Intraoperative Spinal Cord Injury Following Surgical Decompression of a Chronically Compressed Spinal Cord
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spine Disease
Spinal Stenosis
Spinal Injury
Spinal Cord Diseases
Spinal Cord Injuries
Spinal Cord Compression
Spine Degeneration
Keywords: Contrast Enhanced Ultrasound
CEUS
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: South Carolina Spinal Cord Injury Research Fund
First posted: 2022-09-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Contrast Enhanced Ultrasound to determine changes of blood flow in the spinal cord at the site of decompression.
timeFrame: Intra-operative (Approximately 3 hours)
Secondary outcomes:
measure: 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).
timeFrame: Clinical Monitoring (12 months)
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Brian F Saway, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Stephen Kalhorn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Jessica Barley, PhD
role: PRINCIPAL_INVESTIGATOR
References: