Laminectomy Alone Versus Laminectomy and Fusion for Traumatic Cervical Spinal Cord Injury Without Instability: A Randomized Controlled Trial
The aim of study is to compare clinical and radiological outcomes of laminectomy alone to laminectomy and fusion in the treatment of traumatic cervical spinal cord injury without instability.
NCT05360524 — Cervical Spinal Cord Injury
Status: Active, not recruiting
http://inclinicaltrials.com/cervical-spinal-cord-injury/NCT05360524/
Subcutaneous Injection of TNFα Monoclonal Antibody for Treating Traumatic Acute Spinal Cord Injury
The purpose of this study is to evaluate the safety and effectiveness of subcutaneous injection of TNFα monoclonal antibody cells for the treatment of traumatic acute spinal cord injury. Spinal cord injury can be divided into three phases, which are acute (within 2 weeks), sub-acute (2 weeks to 6 months), and chronic (over 6 months). The pathological process of spinal cord injury include primary injury (initial traumatic insult) and a progressive secondary injury cascade characterized by ischemia, proapoptotic signaling, peripheral inflammatory cell infiltration and the release of proinflammatory cytokines. Secondary injury plays a key role in the loss of spinal cord function after trauma. So early treatment to prevent the secondary injury is the key to improve prognosis. TNFα monoclonal antibody is a TNF-α inhibitor that could control inflammatory response, and now widely used in the treatment of Ankylosing spondylitis, Rheumatoid arthritis and other autoimmune diseases. In this study, the investigators will treat patients with acute spinal cord injury with TNFα monoclonal antibody and compare with the control group.
NCT04988425 — Spinal Cord Injuries
Status: Not yet recruiting
http://inclinicaltrials.com/spinal-cord-injuries/NCT04988425/
Intrathecal Transplantation of Autologous Bone Marrow-derived Mononuclear Cells for Treating Traumatic Acute Spinal Cord Injury
The purpose of this study is to evaluate the safety and effectiveness of intrathecal transplantation of autologous bone marrow-derived mononuclear cells for the treatment of traumatic acute spinal cord injury. Spinal cord injury can be divided into three phases, which are acute (within 2 weeks), sub-acute (2 weeks to 6 months), and chronic (over 6 months). Early treatment is the key to improve the prognosis, however, the majority of clinic trails nowadays are focusing on sub-acute or chronic phase because it takes 4-6 weeks to expand the autologous stem cells. In this study, the investigators will treat patients with acute spinal cord injury with autologous bone marrow-derived mononuclear cells and compare with the control group.
NCT04528550 — Spinal Cord Injury
Status: Recruiting
http://inclinicaltrials.com/spinal-cord-injury/NCT04528550/
Diaphragm Electrical Activity in "Spontaneous Breathing Challenge" Reliably Predict Early Extubation in Patients With Traumatic Cervical Spinal Cord Injury
Esophageal recordings of diaphragm electrical activity (EAdi) made it possible to monitor respiratory drive and the subsequent phrenic nerve conduction and respiratory neuromuscular function continuously. Thus, we designed a "spontaneous breathing challenge" test to monitor the change in EAdi after a maximal inspiration. We hypothesized that the absolute change (ΔEAdi) and the percentage changes change (ΔEAdi%) in EAdi after a "spontaneous breathing challenge" predict successful extubation in traumatic CSCI patients during acute hospitalization.
NCT04089956 — Traumatic Cervical Spinal Cord Injury (CSCI)
Status: Completed
http://inclinicaltrials.com/traumatic-cervical-spinal-cord-injury-csci/NCT04089956/
Identification of Autoantibodies and Autoantigens in the Cerebrospinal Fluid of Patients With spinal Cord Trauma
The purpose of the study is to detect the presence of autoantibodies and autoantigens in cerebrospinal fluid early (<48 hours) following spinal cord trauma. The study also aims to define the central or peripheral origin of autoantibodies by looking for their simultaneous presence at the blood level and to evaluate the prognostic value of the presence of autoantibodies within the cerebrospinal fluid, as well as on the initial clinical severity than on the recovery potential.
NCT03249129 — Trauma
Status: Withdrawn
http://inclinicaltrials.com/trauma/NCT03249129/
Hyperbaric Oxygen and Orthopedic Comprehensive Treatment for Traumatic Incomplete Spinal Cord Injury in the Plateau: an Open-label Randomized Controlled Clinical Trial
To observe modified Barthel index, American Spinal Injury Association (ASIA) impairment scale grading, sensory score and motor score in patients with incomplete SCI in the plateau using 0.2 MPa HBO combined with pedicle screw fixation and decompressive laminectomy so as to investigate the effect of HBO therapy on incomplete SCI in the plateau.
NCT03112941 — Spinal Cord Injuries
Status: Completed
http://inclinicaltrials.com/spinal-cord-injuries/NCT03112941/
Riluzole in the Treatment of Spasticity in the Traumatic Chronic Spinal Cord Injury Condition: Adaptive, Multicenter, Placebo-controlled, Randomised, Double Blind Trial in a Rare Disorder
The study will be conducted in two steps: 1. Determination of the Minimal Effective Dose (MED) among the four doses of the panel 2. Estimation of the probability of response associated to the MED. Each step has a main objective: Step 1 Objective: To determine a daily dose of Riluzole that improves spasticity in patients with chronic SCI Step 2 Objective: To demonstrate, in a phase 2b trial, the efficacy of Riluzole to improve spasticity vs placebo, in patients with chronic SCI.
NCT02859792 — Spinal Cord Injury
Status: Recruiting
http://inclinicaltrials.com/spinal-cord-injury/NCT02859792/
Safety and Pharmacokinetics of Riluzole in Patients With Traumatic Acute Spinal Cord Injury
The purpose of the study is to find out if the use of the drug Riluzole is both safe and improves outcome in patients with acute traumatic spinal cord injury (SCI).
NCT00876889 — Spinal Cord Injury
Status: Completed
http://inclinicaltrials.com/spinal-cord-injury/NCT00876889/
Prognostic Factors and Therapeutic Effects of Surgical Treatment for Traumatic Spinal Column Injury With Spinal Cord Injury: A Prospective, Observational European Multi-center Study.
Despite many years of research, an incomprehensible amount of scientific efforts worldwide and billions of dollars invested, no effective therapy resulting in major neurological or functional recovery is available to date for traumatic spinal cord injury (tSCI). Although there is increasing experimental evidence from animal models that surgical decompression of the spinal cord improves recovery after tSCI, clinical studies have not shown conclusive data yet. The main explanations for this lack of convincing evidence are relatively small sample sizes in previous studies, their predominantly retrospective nature, suboptimal measurement methods for the assessment of neurological deficits, and inappropriate recording and documentation of potential confounding factors.
NCT01674764 — Acute Spinal Cord Injury of Traumatic Origin (tSCI)
Status: Completed
http://inclinicaltrials.com/acute-spinal-cord-injury-of-traumatic-origin-tsci/NCT01674764/
A Phase I/II, Randomized, Double-blind, Placebo-controlled, Parallel, 2-arms Clinical Trial to Assess the Safety and Efficacy of Intrathecal Administration of WJ-MSC in Chronic Traumatic Cervical Incomplete Spinal Cord Injury
This is a double-blind, randomized, placebo-controlled, multicenter clinical trial in which 18 patients affected with chronic traumatic incomplete cervical spinal cord injury will be randomized to either the active treatment (2 doses of intrathecal WJ-MSC 3 months apart) or to placebo (2 intrathecal infusions, 3 months apart). Thereafter, patients will be followed-up for 12 months for safety and efficacy assessment.
NCT05054803 — Spinal Cord Injury Cervical
Status: Completed
http://inclinicaltrials.com/spinal-cord-injury-cervical/NCT05054803/