NCT06654804 · University of Washington
Contrast-enhanced Ultrasound in the Treatment of Acute Spinal Cord Injury
What this study is about
Patients with traumatic spinal cord injury (tSCI) often suffer from spinal cord swelling inside the thecal sac, which contains the spinal cord and surrounding fluid, leading to increased pressure on the spinal cord tissue and decreased spinal cord blood flow at the site of injury.
View original scientific description
Patients with traumatic spinal cord injury (tSCI) often suffer from spinal cord swelling inside the thecal sac, which contains the spinal cord and surrounding fluid, leading to increased pressure on the spinal cord tissue and decreased spinal cord blood flow at the site of injury. The combination of increased pressure and decreased blood flow causes vascular hypoperfusion of the spinal cord and exacerbates the severity of injury. This is also referred to as secondary injury. Thus, knowledge of spinal cord hypoperfusion would allow the treating physician to optimize the hemodynamic condition of the patient with acute spinal cord injury and potentially improve functional outcomes.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 18 years of age minimum
- Acute spinal cord injury fpr less than 24 hours
- Injury ranging from mild spinal cord injury where motor function is preserved (AIS A) to complete injury where there is no motor or sensory function below the leel of the injury (AIS D)
- Medically stable to undergo routine dorsal decompression, spinal realignment
- and stabilizing with segmental instrumentation
Exclusion criteria
- Younger than 18 years old
- Neurological lower extremity exam missing or intact
- Traumatic head injury with a Glasgow score of 11 or lower
- Cord injury level caudal to T10 (thoracic spine level 10)
- A known sensitivity to lipid microsphere or its components, such as polyethylene glycol (PEG)
- A history of anaphylactoid reactions from ultrasound enhancing agents
- A known history of cardiopulmonary conditions
- Cardiac shunt
Where
- Seattle, Washington
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 27, 2025 · Source of record for eligibility and locations