Spinal Cord Compression, Spinal Cord Diseases, Spinal Cord Injuries, Spinal Injury, Spinal Stenosis, Spine Degeneration, Spine Disease
Conditions
Keywords
Contrast Enhanced Ultrasound, CEUS
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.
Interventions
DEVICEDefinity 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.
Sponsors
Medical University of South Carolina
South Carolina Spinal Cord Injury Research Fund
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Spinal Cord Contrast-Enhanced Ultrasound Signal Intensity Before and After Surgical Decompression | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBrian F Saway, MD
Medical University of South Carolina
PRINCIPAL_INVESTIGATORStephen Kalhorn, MD
Medical University of South Carolina
PRINCIPAL_INVESTIGATORJessica Barley, PhD
Medical University of South Carolina
Participant flow
Pre-assignment details
No significant events occurred
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age, Continuous | 68.4 Years STANDARD_DEVIATION 8.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
None listed