Spinal Cord Injuries Clinical Trial
Official title:
"OMNI-SCI" Trial - "Optical Monitoring With Near-Infrared Spectroscopy for Spinal Cord Injury" Trial
The study involves the 'first-in-human' evaluation of a novel optical sensor which uses near-infrared spectroscopy (NIRS) technology to assess oxygenation and hemodynamics of the injured spinal cord. The NIRS sensor is laid on top of the dura, at the site of the SCI, and emits near-infrared light signals into the cord to measure tissue oxygenation and tissue hemodynamics in real-time. Our testing of this novel NIRS sensor in patients with acute SCI represents the first step in translating this technology for human use.
This single-center, prospective observational study will enroll 10 patients admitted to Vancouver General Hospital (VGH) for treatment of an acute traumatic spine injury. Promising preclinical data demonstrates that the oxygenation and hemodynamic measures of our Near Infra-Red Spectroscopy (NIRS) system closely match the invasive intraparenchymal measures obtained within the injured spinal cord. Further, the NIRS sensor is responsive and reflective of systemic hemodynamic changes. This clinical protocol represents the first application of this novel NIRS sensor in human SCI. Following operative decompression of the spinal cord via a posterior approach, the NIRS sensor will be placed over the dura for 7 days to monitor spinal cord oxygenation and tissue hemodynamics. Patients will be followed for 6 months and data collection for safety, feasibly and efficacy of the NIRS System. The specific aims of this project are to: 1. Establish the safety, feasibility, and efficacy of our NIRS system in monitoring tissue oxygenation and hemodynamics of the injured spinal cord in human participants. 2. Complete the technical refinement of the NIRS system utilizing an iterative process guided by participant recruitment and data accrual during the trial. ;
| 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
|
||
| Completed |
NCT03220451 -
Use of Adhesive Elastic Taping for the Therapy of Medium/Severe Pressure Ulcers in Spinal Cord Injured Patients
|
N/A | |
| Terminated |
NCT03170557 -
Randomized Comparative Trial for Persistent Pain in Spinal Cord Injury: Acupuncture vs Aspecific Needle Skin Stimulation
|
N/A | |
| Recruiting |
NCT04736849 -
Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury
|
N/A | |
| Active, not recruiting |
NCT05558254 -
ROBERT® as an Intervention to Enhance Muscle Strength After Spinal Cord Injury
|
N/A |