Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04811235
Other study ID # H20-01259.
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 24, 2022
Est. completion date September 30, 2024

Study information

Verified date June 2023
Source University of British Columbia
Contact Allan Aludino
Phone 604-875-4111 ext 61689
Email allan.aludino@vch.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date September 30, 2024
Est. primary completion date June 2, 2024
Accepts healthy volunteers No
Gender All
Age group 17 Years and older
Eligibility Inclusion Criteria: - Male or female aged 17 years or older - Spinal injury between bony levels C3 and L1 inclusive - Motor complete acute traumatic SCI (AIS A or B) or motor incomplete SCI (AIS C) with a total lower extremity motor score of less than 5 - Blunt (non-penetrating) SCI requiring posterior laminectomy with stabilization/fusion surgery within 72 hours of injury - Able to communicate in English and provide informed consent Exclusion Criteria: - Isolated radiculopathy or cauda equina injury - Spinal cord impairment secondary to tumour, infection, epidural bleeding, or ischemia (in - Any condition or injury (e.g. Morel-Lavellee lesion) that would interfere with the application or readings of the NIRS sensor - Associated traumatic condition that would interfere with the informed consent process or outcome assessments (e.g. traumatic brain injury, pelvic, abdominal, or thoracic injuries) - Any other medical condition that, in the investigator's opinion, would render the protocol procedures dangerous - Female patients who are pregnant

Study Design


Intervention

Device:
Near Infra-Red Spectroscopy (NIRS) Sensor
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.

Locations

Country Name City State
Canada Vancouver General Hospital Vancouver British Columbia

Sponsors (2)

Lead Sponsor Collaborator
University of British Columbia United States Department of Defense

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Safety Assessment - Neurologic Function Neurologic function will be assessed using the International Standards for Neurologic Classification of Spinal Cord Injury (ISNCSCI) to determine if the application, 7-day placement, or removal of the NIRS sensor is associated with any deterioration in spinal cord function. 6 Month
Other Safety Assessment - Wound Assessment The externalization of a foreign body may lead to an increased risk of surgical site infection. Any incidence of wound infection will be monitored and document on a wound assessment form. Day 7
Other Safety Assessment - Adverse Events The incidence of AEs in the acute SCI patient population is significant. For the purposes of this study, and in keeping with standard of care on the Acute Spine Unit at study site, all AEs will be recorded utilizing the Spine Adverse Event (SAVES) form, a well-established system for prospectively documenting AEs in spine patients 6 Months
Primary Feasibility Assessment - Overall Study specific questionnaire will collected data on the the ease of sensor application, NIRS monitoring and sensor removal is recorded with this form. Series of questions requiring the assessment of the NIRS system using yes/no and 10-point scoring scale Day 7
Primary Feasibility Assessment: Sensor Application Study specific form will be used record data associated with application of the NIRS sensor, such as the laminectomy and instrumentation data, location of the sensor and ease of application (score out of 10). Day 1
Primary Feasibility Assessment: Sensor Removal Study specific form will be used to record the condition of the sensor and participants' experience (score out of 10) at the time of sensor removal Day 7
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 NCT03680872 - Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System N/A
Recruiting NCT04105114 - Transformation of Paralysis to Stepping Early Phase 1
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