CEUS For Intraoperative Spinal Cord Injury

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05530798
Study type	Interventional
Source	Medical University of South Carolina
Contact	Brian F Saway, MD
Phone	8434940234
Email	saway@musc.edu
Status	Recruiting
Phase	N/A
Start date	December 1, 2023
Completion date	October 1, 2024

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT06321172` - Muscle and Bone Changes After 6 Months of FES Cycling	N/A
Completed	`NCT03457714` - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting	`NCT05484557` - Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury	N/A
Suspended	`NCT05542238` - The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury	N/A
Recruiting	`NCT05503316` - The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System	N/A
Not yet recruiting	`NCT05506657` - Early Intervention to Promote Return to Work for People With Spinal Cord Injury	N/A
Recruiting	`NCT04105114` - Transformation of Paralysis to Stepping	Early Phase 1
Recruiting	`NCT03680872` - Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System	N/A
Completed	`NCT04221373` - Exoskeletal-Assisted Walking in SCI Acute Inpatient Rehabilitation	N/A
Completed	`NCT00116337` - Spinal Cord Stimulation to Restore Cough	N/A
Completed	`NCT03898700` - Coaching for Caregivers of Children With Spinal Cord Injury	N/A
Recruiting	`NCT04883463` - Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury	N/A
Active, not recruiting	`NCT04881565` - Losing Balance to Prevent Falls After Spinal Cord Injury (RBT+FES)	N/A
Completed	`NCT04864262` - Photovoice for Spinal Cord Injury to Prevent Falls	N/A
Recruiting	`NCT04007380` - Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI	N/A
Active, not recruiting	`NCT04544761` - Resilience in Persons Following Spinal Cord Injury
Terminated	`NCT03170557` - Randomized Comparative Trial for Persistent Pain in Spinal Cord Injury: Acupuncture vs Aspecific Needle Skin Stimulation	N/A
Completed	`NCT03220451` - Use of Adhesive Elastic Taping for the Therapy of Medium/Severe Pressure Ulcers in Spinal Cord Injured Patients	N/A
Recruiting	`NCT04811235` - Optical Monitoring With Near-Infrared Spectroscopy for Spinal Cord Injury Trial	N/A
Recruiting	`NCT04736849` - Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.