Using ultrasound to improve treatment for acute spinal cord injury
Contrast-Enhanced Ultrasound Biomarker for Prognostication and Guidance of Surgical Treatment in Acute Traumatic Spinal Cord Injury
This study is testing if using special ultrasound during spinal surgery can help doctors see blood flow in patients with acute spinal cord injuries to improve their treatment and recovery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT06654804 on ClinicalTrials.gov |
What this trial studies
This study aims to utilize contrast-enhanced ultrasound (CEUS) to assess blood flow in the spinal cord of patients with acute spinal cord injury during routine surgical procedures. By measuring blood flow at the injury site, the investigators hope to optimize treatment strategies that could enhance blood circulation and potentially improve patient outcomes. The CEUS will be performed after the key surgical steps of decompression and stabilization, ensuring that it does not delay or complicate the surgery. Participants will also undergo routine MRI imaging post-operatively to further evaluate their condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with acute spinal cord injuries occurring within the last 24 hours.
Not a fit: Patients with certain contraindications, such as severe traumatic head injuries or known sensitivities to ultrasound enhancing agents, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved functional outcomes for patients suffering from acute spinal cord injuries.
How similar studies have performed: While the use of CEUS in spinal cord injury is a novel approach, similar imaging techniques have shown promise in other areas of medicine.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Seattle, Washington
- University of Washington Harborview Medical Center — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Christoph Hofstetter, MD, PhD — University of Washington
- Study coordinator: Amy Anderson
- Email: amya9@uw.edu
- Phone: 206-744-9364
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.