NCT06654804 Contrast-enhanced Ultrasound in the Treatment of Acute Spinal Cord Injury
| NCT ID | NCT06654804 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Washington |
| Condition | Acute Spinal Cord Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-09-28 |
| Primary Completion | 2027-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 50 participants in total. It began in 2023-09-28 with a primary completion date of 2027-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Christoph Hofstetter, MD, PhD
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT06654804 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Spinal Cord Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06654804 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06654804 currently recruiting?
Yes, NCT06654804 is actively recruiting participants. Contact the research team at amya9@uw.edu for enrollment information.
Where is the NCT06654804 trial being conducted?
This trial is being conducted at Seattle, United States.
Who is sponsoring the NCT06654804 clinical trial?
NCT06654804 is sponsored by University of Washington. The principal investigator is Christoph Hofstetter, MD, PhD at University of Washington. The trial plans to enroll 50 participants.