What is the mechanism of action of this treatment?

Common treatments for spinal cord injury (SCI) include surgical decompression, neuroprotective agents, and advanced imaging techniques like Contrast Enhanced Ultrasound (CEUS). CEUS utilizes nanobubble technology to visualize the micro- and macrovascular architecture of the spinal cord, helping to detect areas of hyper-perfusion and ischemia. This is crucial for intraoperative monitoring and predicting post-operative outcomes, potentially improving recovery. Surgical decompression alleviates pressure on the spinal cord, while neuroprotective agents aim to minimize secondary damage. Together, these treatments are essential for optimizing recovery and functional outcomes in SCI patients.

What side effects are associated with this type of intervention?

Common treatments for spinal cord injury (SCI) include imaging and monitoring techniques such as intraoperative neuromonitoring (IONM) and Doppler ultrasound, as well as pharmacological treatments and stem cell therapies. IONM is generally safe but can occasionally cause false positives or negatives, leading to unnecessary interventions or missed injuries. Doppler ultrasound is non-invasive and has minimal side effects, though it may sometimes cause discomfort. Pharmacological treatments like corticosteroids can reduce inflammation but may lead to side effects such as immunosuppression, gastrointestinal issues, and increased infection risk. Stem cell therapies show promise but can carry risks of immune reactions, infection, and potential tumor formation. CEUS, being non-invasive and radiation-free, is generally considered safe, but the long-term effects of nanobubble technology are still under investigation.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically utilizing Contrast Enhanced Ultrasound (CEUS) with nanobubble technology for spinal cord injury. However, the FDA has approved various other treatments for spinal cord injury, including surgical interventions, physical therapy, and medications such as corticosteroids to reduce inflammation. Additionally, investigational therapies like stem cell treatments and neuroprotective agents are being explored in clinical trials, but they have not yet received FDA approval.

What other types of research exist?

Promising alternatives to CEUS for spinal cord injury patients include: 1) Intraoperative Neuromonitoring (IONM), which remains the gold standard for predicting and preventing post-operative deficits. 2) Advanced MRI techniques, such as dynamic contrast-enhanced MRI, which can provide detailed images of vascular structures and tissue perfusion. 3) Optical Coherence Tomography (OCT), which offers high-resolution imaging of microvascular changes. These alternatives are being actively researched and may offer effective visualization and assessment of spinal cord injuries in 2024.

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CEUS for Spinal Cord Injury

N/A

Recruiting

Led By Brian F Saway, MD

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up clinical monitoring (12 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new imaging method called Contrast Enhanced Ultrasound (CEUS) to help doctors see blood flow changes in the spinal cord during surgery. It aims to help patients having surgery for chronic spinal cord pressure in the neck and upper back. The goal is to predict and prevent nerve damage by spotting blood flow issues early. CEUS has been used in various studies to visualize and assess blood flow in the spinal cord, including during surgery.

Who is the study for?

This trial is for adults aged 18-80 who are scheduled for posterior cervicothoracic decompression surgery to treat spinal cord compression. It's not suitable for those allergic to perflutren lipid microsphere or its components, pregnant individuals, patients with prior surgery at the same spot, or anyone unable to consent due to physical/cognitive reasons.

What is being tested?

The study tests if a contrast agent called Definity Perflutren Lipid Microsphere Ultrasound Contrast can help visualize blood flow changes in the spine during surgery. The goal is to see if it predicts and shows recovery from spinal cord injuries better than current methods.

What are the potential side effects?

Potential side effects may include reactions related to hypersensitivity such as itching, swelling, or difficulty breathing especially in those with known allergies to any of the contrast agent's components.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ clinical monitoring (12 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~clinical monitoring (12 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and clinical monitoring (12 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Spinal Cord

Secondary study objectives

Perfusion (procedure)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Contrast Enhanced Ultrasound ArmExperimental Treatment1 Intervention

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for spinal cord injury (SCI) include surgical decompression, neuroprotective agents, and advanced imaging techniques like Contrast Enhanced Ultrasound (CEUS). CEUS utilizes nanobubble technology to visualize the micro- and macrovascular architecture of the spinal cord, helping to detect areas of hyper-perfusion and ischemia. This is crucial for intraoperative monitoring and predicting post-operative outcomes, potentially improving recovery. Surgical decompression alleviates pressure on the spinal cord, while neuroprotective agents aim to minimize secondary damage. Together, these treatments are essential for optimizing recovery and functional outcomes in SCI patients.

Hyperbaric oxygen therapy of spinal cord injury.