Biomarkers of Immune Dysfunction and Vaccine Responsiveness in People With Chronic Traumatic Spinal Cord Injury
The purpose of this observational research study is to better understand immune responses to vaccines against viruses (influenza or SARS-CoV2). The goal is to determine any differences in immune responses to vaccines in uninjured people and in people living with spinal cord injuries, who are typically at increased risk of infections.
NCT05869968 — Spinal Cord Injuries
Status: Recruiting
http://inclinicaltrials.com/spinal-cord-injuries/NCT05869968/
Determining the Most Appropriate Time to Evaluate Detrusor Activity Recovery in Acute Traumatic Spinal Cord Injuries
Determining the most appropriate time to evaluate detrusor activity in urodynamic studies for both traumatic and non-traumatic spinal cord injuries
NCT05207826 — Spinal Cord Injuries
Status: Not yet recruiting
http://inclinicaltrials.com/spinal-cord-injuries/NCT05207826/
Reliability and Validity of the International Standards for Neurological Classification of Spinal Cord Injury in Patients With Non-traumatic Spinal Cord Lesions
Aim of the study is to assess the psychometric properties of the International Standards for Neurological Classification of Spinal Cord Injury in subjects with non traumatic lesions.
NCT04949763 — Spinal Cord Injuries
Status: Completed
http://inclinicaltrials.com/spinal-cord-injuries/NCT04949763/
Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury (PROMPT-SCI)
PROMPT-SCI (Protocol for Rapid Onset of Mobilization in Patients with Traumatic SCI) is a single-site single-arm proof-of-concept trial. Forty-five patients aged 18 years or older who have sustained a severe traumatic SCI (American Spinal Injury Association Impairment Scale grade A, B or C) from C0 to L1 and undergoing spinal surgery within 48 hours of the injury will be included. Participants will receive daily 30-minute sessions of in-bed leg cycling for 14 consecutive days, initiated within 48 hours after spinal surgery. The feasibility outcomes consist of the 1) absence of serious adverse events associated with cycling sessions, 2) completion of at least 1 full session within 48 hours after spinal surgery for at least 90% of participants, and 3) completion of at least 11 sessions for at least 80% of participants. Patient outcomes 6 weeks and 6 months after injury will be measured from neurofunctional assessments, quality of life questionnaires and inpatient length of stay. Feasibility and patient outcomes will be analysed with descriptive statistics. Patient outcomes will also be compared to a matched historical cohort not receiving in-bed cycling.
NCT04699474 — Spinal Cord Injuries
Status: Recruiting
http://inclinicaltrials.com/spinal-cord-injuries/NCT04699474/
Intraspinal Pressure Monitoring for Acute Traumatic spinal Cord Injury: A Validation Study
Intraspinal pressure monitoring has been advanced as a potential technique for evaluating spinal cord perfusion after traumatic spinal cord injury. In this study, the investigators aim to validate the technique for insertion of a fiberoptic pressure monitoring device in the subarachnoid space at the site of injury for measurement of intraspinal pressure and spinal cord perfusion pressure. The primary objective of this study is to validate the methodology of invasive intraspinal pressure monitoring to derive parameters for optimal spinal cord perfusion pressure, spinal cord reserve capacity and spinal reactivity index using data obtained during the patient's stay in the intensive care unit. Secondary objectives of this study will be to a) evaluate the safety of invasive intraspinal pressure monitoring, b) prospectively evaluate the overall relationship between spinal cord perfusion pressure and functional outcomes in patients with acute traumatic spinal cord injury and c) evaluate the relationship between spinal cord perfusion pressure, motor evoked potentials and functional outcomes after incomplete spinal cord injury.
NCT04550117 — Spinal Cord Injuries
Status: Recruiting
http://inclinicaltrials.com/spinal-cord-injuries/NCT04550117/
Preventing Neurogenic Obesity Following Traumatic Spinal Cord Injury
This is a randomized clinical controlled trial (RCT) to investigate the impact of a personalized nutritional intervention on functional and clinical outcomes the first year after traumatic spinal cord injury. The long term goal is to prevent gain of body fat mass and obesity.
NCT04109586 — Obesity
Status: Recruiting
http://inclinicaltrials.com/obesity/NCT04109586/
Treating Cognitive Deficits in Traumatic Spinal Cord Injury (SCI): A Randomized Clinical Trial
The purpose of this research study is to investigate the effectiveness of a memory retraining program and a processing speed program in a spinal cord injured (SCI) population. The study is designed to research how well different types of techniques can help people with SCI improve in areas where they might have difficulties such as memory or processing speed, (time it takes to process information provided).
NCT03985540 — Spinal Cord Injuries
Status: Completed
http://inclinicaltrials.com/spinal-cord-injuries/NCT03985540/
The Neuroinflammatory Response and Biomarkers in Acute Traumatic Spinal Cord Injury: A Pilot Study
The study is a prospective cohort study designed to assess the diagnostic and prognostic potential of biomarker measurement in acute traumatic spinal cord injury (TSCI), and to examine the neuroinflammatory response to acute TSCI.
NCT03505463 — Spinal Cord Injury, Acute
Status: Active, not recruiting
http://inclinicaltrials.com/spinal-cord-injury-acute/NCT03505463/
Motor, Sensory, and Autonomic Function After Laparoscopic Implantation of Neuroprosthesis - a Randomized Controlled Trial of the LION Procedure in Traumatic Spinal Cord Injury
Possover pioneered a minimally invasive and fully reversible laparoscopic technique, laparoscopic implantation of neuroprosthesis (LION), for precise placement of an implantable pulse generator and one to four leads for stimulating nerves of the lumbosacral plexus. Unexpectedly, Possover in 2014 made the clinical observation that four patients with complete and incomplete chronic traumatic spinal cord injury regained significant motor and sensory function following the LION procedure for bladder and bowel dysfunction. The primary objective of this randomized clinical trial is to investigate whether the LION procedure and the subsequent neurostimulation in individuals with chronic traumatic thoracolumbar spinal cord injury with spastic paraplegia is associated with increased walking capacity.
NCT03441256 — Spinal Cord Injuries
Status: Completed
http://inclinicaltrials.com/spinal-cord-injuries/NCT03441256/
Strengthening Health Systems for Persons With Traumatic Spinal Cord Injury in South Africa and Sweden: a Protocol for a Longitudinal Study of Processes and Outcomes
A traumatic spinal cord injury (TSCI) often causes an unprecedented change in functioning by altering bodily structure and function. More specifically, the direct consequences of TSCI to the motor, sensory and autonomic nervous system not only challenge an individual's independency but also the ability to make a positive adjustment to life after injury. In line with this, TSCI survivors often experience threats to their livelihood and becoming integrated members of society. Health systems therefore need to be ready to respond to the myriad of challenges following a TSCI by providing access to specialized and comprehensive services. The provision of specialized care in a time-sensitive manner has shown to be crucial for survival and recovery of functioning after a traumatic spinal cord injury (TSCI). However, little is known about the provision of TSCI care in different international contexts; information which is required for strengthening policy and practice.
NCT03437850 — Spinal Cord Injuries
Status: Recruiting
http://inclinicaltrials.com/spinal-cord-injuries/NCT03437850/