Study of Human Central Nervous System (CNS) Stem Cell Transplantation in Cervical Spinal Cord Injury...
Cervical Spinal Cord InjurySpine Injury1 moreThis study will evaluate the safety and efficacy of human central nervous system stem cell transplantation into patients with traumatic injury in the cervical region of the spinal cord.
DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery
Spinal InjuriesAdhesionsTo evaluate the safety and effectiveness of DuraGen Plus® Adhesion Barrier Matrix as an adhesion barrier in spinal surgery to reduce the extent of peridural fibrosis formation and radicular pain in comparison to a control group receiving standard care.
Adherence of Imaging Order to the 2020 French Guidelines for Patients With Cervical Spine Injury...
Cervical Spine InjuryCervical spine trauma is a frequent reason for consultation in emergency medicine. It concerns approximately 10,000 patients admitted to the emergency room each year in France. There are two types of cervical spine trauma: penetrating and non-penetrating. Non-penetrating injuries are the most frequent and can be classified according to the mechanism involved. Whiplash is the most common type of trauma in emergency medicine. The injuries associated with this type of trauma predominate in the mobile spinal segment and are most often benign: only 2 to 3% of conscious patients consulting the emergency room actually present with cervical injuries such as fractures, dislocations or unstable sprains. In emergency medicine, the paradigm is therefore to identify patients at risk of complications, minimizing the need for unnecessary and radiating imaging. Although cervical spine trauma is a frequent reason for emergency room visits, the incidence of anatomical lesions is generally low and the X-rays prescribed most often do not show any abnormality. For cervical lesion screening to be safe and effective, the screening rules must have a high sensitivity, a low negative likelihood ratio, and a low false positive rate. Two clinical prediction rules have been extensively evaluated in the literature to guide imaging for nonpenetrating cervical injuries: the National Emergency X-Radiography Utilization Study (NEXUS) rule and the Canadian C-Spine 5 rule. The NEXUS rule4 applies to any clinically stable patient (Glasgow Coma Scale 15, systolic blood pressure ≥ 90 mmHg, and respiratory rate between 10 and 24/min) presenting to the emergency department with a nonpenetrating trauma. The criteria constituting the NEXUS clinical rule are: Absence of tenderness on palpation of the posterior cervical midline ; Normal state of alertness (Glasgow Coma Scale 15); Absence of focal neurological deficit; Absence of signs of intoxication; Absence of distracting pain (other pain that may mask neck pain, e.g., long bone fracture). If these 5 criteria are present, the risk of cervical spine injury is low and no imaging is recommended. The Canadian C-Spine 5 rule applies to patients who are 16 years of age or older; conscious with a Glasgow Coma Scale of 15; stable (systolic blood pressure ≥ 90 mmHg and respiratory rate between 10 and 24/min); and have had head or neck trauma in the past 48 hours. As soon as the rules of clinical prediction do not make it possible to rule out the hypothesis of a spinal injury, the exploration of cervical trauma traditionally involves the performance of radiographic images. They must include the following incidences: face, profile and open mouth centered on the cervico-occipital hinge ("open mouth odontoid"). Nevertheless, the sensitivity of these conventional radiographs for the detection of cervical spine lesions is poor, about 50%. Thus, the use of standard radiographs is usually limited to conscious, ambulatory patients at low risk of spinal injury. Conversely, the cervical CT is the reference examination for the detection of spinal bone lesions with a sensitivity close to 100%. Its sensitivity is superior to that of radiographic images in both high-risk and low-risk patients with spinal injuries. Difficulty of access and exposure to ionizing radiation, which is lower with standard radiography, generally influence the choice of imaging in the emergency room. In December 2020, the French High Authority for Health published a sheet on the relevance of cervical imaging in the context of non-penetrating cervical trauma. This sheet proposes a practical table according to the precise clinical context of the patient as well as the best first-line imaging. These good practice recommendations were part of an approach to improve the relevance of care. Cervical spine imaging for patients admitted to the emergency department for non-penetrating cervical spine trauma was recommended in one of the following situations patient 65 years of age or older ; patient unstable or with consciousness disorders or neurological signs; imaging recommended by one of the following two rules: NEXUS or Canadian C-Spine; a history of ankylosing spine (ankylosing spondylitis, hyperostosis, etc.), even in case of "minor" trauma; if a cervical artery dissection is suspected. Investigator's hypothesis is that the HAS recommendations of good cervical imaging practices for non-penetrating cervical trauma are difficult to apply routinely in emergency departments for several reasons: the frequency of consultations for cervical trauma, the limited availability of emergency CT scans, and the fear of radiation and unnecessary additional costs in emergency situations. Investigators wish to determine the actual rate of application of the clinical rules recommended by the HAS in the GHPSJ emergency department and the factors predicting their non-application by the GHPSJ team of emergency physicians.
Evaluation Of Intra-Operative Neuro-Monitoring Alarm During Complex Spine Surgery
Spine Injuries and DisordersIatrogenic spinal cord injury is the most feared complication of complex spine surgery. The incidence of neurological complications for spinal deformity surgery has been estimated by the Scoliosis Research Society as 1%, except when a combined approach is used, where the rate increases to 1.87% [1]. Intraoperative neuromonitoring (IONM) techniques are usually implemented during spine surgery to avoid nefarious abuse of the nervous system, which can cause postoperative problem [2]. In 1992 a Scoliosis Research Society study concluded that the use of intraoperative spinal cord neurophysiological monitoring during operative procedures including instrumentation should be considered ''a viable alternative as well as an adjunct to the use of the wake-up test during spinal surgery'' [5]. The benefit of using neuromonitoring has been validated by numerous studies involving scoliosis correction, revision surgeries and vertebral osteotomies.
Levetiracetam in Chronic Neuropathic Pain Following Spinal Cord Injury
InjuriesSpinal Cord1 morePurpose: To evaluate the efficacy and safety of levetiracetam on chronic neuropathic pain after spinal cord injury, and to examine its effect on spasms and evoked pain.
Evaluation of a Bowel and Bladder Health Management Program for Individuals With Spinal Cord Injury...
InjuriesSpinal Cord3 moreThis study will look at the use of a telehealth version of a self management program in individuals with both new onset and chronic traumatic spinal cord injuries. The program is called Health Mechanics. It is meant to enhance self management skills related to neurogenic bladder and bowel management to prevent associated problems and improve Quality of Life (QOL). This program is based on the needs and strengths of individuals with SCI. It focuses on enhancing skills, encouraging positive health behaviors, empowering people within their own environments, and recognizing that people differ in their resources and abilities. The skills that are part of the intervention are: attitude, self-monitoring, problem-solving, communication, organization and stress management. This study will address those skills in the context of bladder and bowel health, with expectations that these skills to be useful in other areas of life as well. The investigators hypothesize that individuals in the Health Mechanics intervention group will: show greater improvements in problem solving skills, healthy attitudes about disability and knowledge of SCI management skills than will the control group have greater adherence to recommended bladder and bowel management behaviors than the control group have fewer bladder and bowel complications than the control group have higher levels of QOL than the control group In other words, this study will investigate the effectiveness of a telehealth version of Health Mechanics to enhance self-management skills related to neurogenic bladder and bowel management in an attempt to prevent associated complications and improve QOL.
A Study Evaluating the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury...
Spinal Cord InjuryErectile Dysfunction4 moreTo demonstrate the efficacy, safety and tolerability of sildenafil administered orally, as required, approximately 1 hour prior to sexual activity to men with erectile dysfunction (ED) associated with spinal cord injury (SCI), as well as its effects on the quality of life (QoL) of these patients.
Dose Escalation Study of AST-OPC1 in Spinal Cord Injury
Cervical Spinal Cord InjurySpine Injury1 moreThe purpose of this study is to evaluate the safety of cross sequential escalating doses of AST-OPC1 administered among 5 cohorts at a single time-point between 21 and 42 days post injury, inclusively, to subjects with subacute cervical spinal cord injuries (SCI).
Macintosh and D-Blade® in Simulated Difficult Airway
Difficult IntubationCervical Injury SpineIn the presented study, our aim was to compare intubation conditions regarding the modified Cormack & Lehane score (CL) between the D-Blade® in indirect laryngoscopy or Macintosh blade in direct and indirect laryngoscopy with C-MAC PM® in a simulated setting of a difficult airway in human subjects.
Assessment of Neurorehabilitation in Spinal Cord Injury Using Neuroimage Tools.
InjuriesSpinal CordThe sensorimotor cortex may play a role in the functional recovery after Spinal Cord Injury (SCI) through efference generated in the absence of the afference. OBJECTIVE: The purpose of this study was to evaluate the potential reorganization in the sensorimotor cortex in SCI patients after Body Weight Supported Treadmill Training (BWSTT) associated with conventional motor rehabilitation. METHOD: Seven SCI patients with ASIA C and D participated in this study. They were submitted to a motor-task functional magnetic resonance imaging study (fMRI) before and after the rehabilitation treatment.