Spinal Cord Injury Clinical Trial Award (DOD)

2021 ◽  
Vol 45 (10) ◽  
pp. 3-4
Keyword(s):  
Clinical Trial ◽  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Cord Injury

scholarly journals Outcome Measures for Acute/Subacute Cervical Sensorimotor Complete (AIS-A) Spinal Cord Injury During a Phase 2 Clinical Trial

2012 ◽  
Vol 18 (1) ◽  
pp. 1-14 ◽  
Author(s):  
John Steeves ◽  
Daniel Lammertse ◽  
John Kramer ◽  
Naomi Kleitman,* ◽  
Sukhvinder Kalsi-Ryan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Outcome Measures ◽  
Phase 2 ◽  
Cord Injury ◽  
Phase 2 Clinical Trial

Olfactory Mucosal Auto-transplantation in Spinal Cord Injury: A Clinical Trial, Saudi Arabia

2021 ◽  
pp. 11
Author(s):  
Ahmad Najib Ashraf ◽  
Abdulaziz Shebreen
Keyword(s):  
Clinical Trial ◽  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Sensory Function ◽  
Cell Transplant ◽  
Loss Of Function ◽  
Neurological Improvement ◽  
Cord Injury ◽  
Distinctive Property ◽  
Independent Life

Introduction: Spinal cord injury (SCI) results in loss of nervous tissue and consequently loss of motor and sensory function. Despite significant improvements in the early medical and surgical management of SCI, there is no effective treatment available that restores the injury-induced loss of function to a degree that an independent life can be guaranteed. Restoration of function and reversal of paralysis following SCI is among the most daunting challenges in all of neuroscience research. Methodology: We decided to study the outcomes in chronic SCI (CSCI) after autologous olfactory mucosal transplantation into the spinal cord following detethering of the cord. The human surgical procedure of autologous olfactory mucosal transplantation was first developed by Carlos Lima and his colleagues. These investigators provided guidance for the surgical procedures in this study and the procedures on the first six participants were performed in their presence. Result: Patients were screened at different centers in the kingdom. A stringent inclusion and exclusion criteria were applied. Patients for this clinical trial were selected from individuals that suffered an SCI at least 12 months before their assessment and were chronically paraplegic or tetraplegic. The final twenty participants were selected after screening more than 125 patients.  While some of them were rejected for medical reasons, some refused to participate upon receiving a full briefing and some of them were unable to fulfill the required psychosocial criteria. Conclusion: The details of the patients and the changes observed in their conditions post olfactory mucosal auto-transplantation will be discussed in detail in oral presentation with graphic results with marked significant improvement in motor and sensory levels of SCI patients as compared to before transplantation of olfactory mucosa. Olfactory unsheathing cells (OECs) are glia cells and continuous axon extension and successful topographic targeting of the olfactory receptor neurons responsible for the sense of smell (olfaction). Due to this distinctive property, OECs have been trialed in human cell transplant therapies to assist in the repair of central nervous system injuries, particularly those of the spinal cord. Although many studies have reported neurological improvement, therapy remains inconsistent and requires further improvement.

Cell therapy clinical trial for dogs with chronic spinal cord injury

2010 ◽  
Vol 166 (23) ◽  
pp. 729-729
Author(s):  
N. Granger ◽  
R. J. M. Franklin ◽  
N. Jeffery
Keyword(s):  
Clinical Trial ◽  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Cell Therapy ◽  
Chronic Spinal Cord Injury ◽  
Cord Injury ◽  
Therapy Clinical Trial

scholarly journals TASCI—transcutaneous tibial nerve stimulation in patients with acute spinal cord injury to prevent neurogenic detrusor overactivity: protocol for a nationwide, randomised, sham-controlled, double-blind clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e039164 ◽  
Author(s):  
Veronika Birkhäuser ◽  
Martina D Liechti ◽  
Collene E Anderson ◽  
Lucas M Bachmann ◽  
Sarah Baumann ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Tibial Nerve ◽  
Ethics Committee ◽  
Neurogenic Detrusor Overactivity ◽  
Double Blind ◽  
Tibial Nerve Stimulation ◽  
Double Blind Clinical Trial ◽  
Cord Injury

IntroductionNeurogenic lower urinary tract dysfunction (NLUTD), including neurogenic detrusor overactivity (NDO) and detrusor sphincter dyssynergia, is one of the most frequent and devastating sequelae of spinal cord injury (SCI), as it can lead to urinary incontinence and secondary damage such as renal failure. Transcutaneous tibial nerve stimulation (TTNS) is a promising, non-invasive neuromodulatory intervention that may prevent the emergence of the C-fibre evoked bladder reflexes that are thought to cause NDO. This paper presents the protocol for TTNS in acute SCI (TASCI), which will evaluate the efficacy of TTNS in preventing NDO. Furthermore, TASCI will provide insight into the mechanisms underlying TTNS, and the course of NLUTD development after SCI.Methods and analysisTASCI is a nationwide, randomised, sham-controlled, double-blind clinical trial, conducted at all four SCI centres in Switzerland. The longitudinal design includes a baseline assessment period 5–39 days after acute SCI and follow-up assessments occurring 3, 6 and 12 months after SCI. A planned 114 participants will be randomised into verum or sham TTNS groups (1:1 ratio), stratified on study centre and lower extremity motor score. TTNS is performed for 30 min/day, 5 days/week, for 6–9 weeks starting within 40 days after SCI. The primary outcome is the occurrence of NDO jeopardising the upper urinary tract at 1 year after SCI, assessed by urodynamic investigation. Secondary outcome measures assess bladder and bowel function and symptoms, sexual function, neurological structure and function, functional independence, quality of life, as well as changes in biomarkers in the urine, blood, stool and bladder tissue. Safety of TTNS is the tertiary outcome.Ethics and disseminationTASCI is approved by the Swiss Ethics Committee for Northwest/Central Switzerland, the Swiss Ethics Committee Vaud and the Swiss Ethics Committee Zürich (#2019-00074). Findings will be disseminated through peer-reviewed publications.Trial registration numberNCT03965299.

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