Patient Recruitment into Acute Spinal Cord Injury Clinical Trials of Early Therapeutic Interventions: How Many Patients Can Really Be Enrolled?

2011 ◽  
Vol 11 (10) ◽  
pp. S14
Author(s):  
Robert Lee ◽  
Marcel Dvorak ◽  
Brian K. Kwon
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Clinical Trials ◽  
Acute Spinal Cord Injury ◽  
Therapeutic Interventions ◽  
Patient Recruitment ◽  
Cord Injury

Feasibility of patient recruitment into clinical trials of experimental treatments for acute spinal cord injury

2012 ◽  
Vol 19 (10) ◽  
pp. 1338-1343 ◽  
Author(s):  
Robert S. Lee ◽  
Vanessa K. Noonan ◽  
Juliet Batke ◽  
Arvindera Ghag ◽  
Scott J. Paquette ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Clinical Trials ◽  
Acute Spinal Cord Injury ◽  
Patient Recruitment ◽  
Cord Injury ◽  
Experimental Treatments

Review of clinical trials of neuroprotection in acute spinal cord injury

1999 ◽  
Vol 6 (1) ◽  
pp. E10 ◽  
Author(s):  
Charles H. Tator ◽  
Michael G. Fehlings
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Clinical Trials ◽  
Treatment Time ◽  
Time Window ◽  
Current Knowledge ◽  
Acute Spinal Cord Injury ◽  
Randomized Controlled Studies ◽  
Cord Injury ◽  
Therapeutic Time Window

In this paper the authors review the clinical trials of neuroprotection that have been performed for the treatment of acute spinal cord injury (SCI). The biological rationale for the selection of each treatment modality is discussed with reference to current knowledge of the principles in the management of acute SCI as well as the primary and secondary injury mechanisms identified by experimental and clinical studies of the pathophysiology of acute SCI. The trials are evaluated with regard to the availability and use of accurate clinical outcome measures, and the methodologies of the trials are critically evaluated with an emphasis on prospective randomized controlled studies. A detailed description and critical analysis are provided of the results of the 10 clinical trials conducted to date in which a randomized prospective controlled design has been used. The issue of the therapeutic time window in acute SCI is discussed. To date, methylprednisolone is the only effective neuroprotective agent that has been established for use in human SCI, and the only therapeutic time window established in human SCI is a maximum trauma-to-treatment time of 8 hours.

Respiratory Care for Spinal Cord Injury

2013 ◽  
Vol 749 ◽  
pp. 258-261
Author(s):  
Yan Chun Zhu ◽  
Jun Chang ◽  
Zhi Gang Sheng
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Acute Spinal Cord Injury ◽  
Therapeutic Interventions ◽  
Respiratory Care ◽  
Respiratory Complications ◽  
Dependency Care ◽  
High Dependency ◽  
Cord Injury ◽  
High Dependency Care

In this paper the issue of respiratory complications following acute spinal cord injury with reference to the area of high dependency care is considered. It will deal with the pathophysiology behind acute spinal cord injury and its effect on the respiratory system, while discussing the interventions used to prevent these complications. A multitude of therapeutic interventions in the care of respiratory complications has been identified. And positioning, chest physiotherapy and assisted coughing techniques will be considered in this paper.

Protection and repair of the injured spinal cord: a review of completed, ongoing, and planned clinical trials for acute spinal cord injury

2008 ◽  
Vol 25 (5) ◽  
pp. E14 ◽  
Author(s):  
Gregory W. J. Hawryluk ◽  
James Rowland ◽  
Brian K. Kwon ◽  
Michael G. Fehlings
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Clinical Trials ◽  
Phase Ii ◽  
Sodium Succinate ◽  
Thyrotropin Releasing Hormone ◽  
Acute Spinal Cord Injury ◽  
Releasing Hormone ◽  
Methylprednisolone Sodium Succinate ◽  
Cord Injury

Over the past 2 decades, advances in understanding the pathophysiology of spinal cord injury (SCI) have stimulated the recent emergence of several therapeutic strategies that are being examined in Phase I/II clinical trials. Ten randomized controlled trials examining methylprednisolone sodium succinate, tirilizad mesylate, monosialotetrahexosylganglioside, thyrotropin releasing hormone, gacyclidine, naloxone, and nimodipine have been completed. Although the primary outcomes in these trials were laregely negative, a secondary analysis of the North American Spinal Cord Injury Study II demonstrated that when administered within 8 hours of injury, methylprednisolone sodium succinate was associated with modest clinical benefits, which need to be weighed against potential complications. Thyrotropin releasing hormone (Phase II trial) and monosialotetrahexosylganglioside (Phase II and III trials) also showed some promise, but we are unaware of plans for future trials with these agents. These studies have, however, yielded many insights into the conduct of clinical trials for SCI. Several current or planned clinical trials are exploring interventions such as early surgical decompression (Surgical Treatment of Acute Spinal Cord Injury Study) and electrical field stimulation, neuroprotective strategies such as riluzole and minocycline, the inactivation of myelin inhibition by blocking Nogo and Rho, and the transplantation of various cellular substrates into the injured cord. Unfortunately, some experimental and poorly characterized SCI therapies are being offered outside a formal investigational structure, which will yield findings of limited scientific value and risk harm to patients with SCI who are understandably desperate for any intervention that might improve their function. Taken together, recent advances suggest that optimism for patients and clinicians alike is justified, as there is real hope that several safe and effective therapies for SCI may become available over the next decade.

Predicting Recruitment Feasibility for Acute Spinal Cord Injury Clinical Trials in Canada Using National Registry Data

2017 ◽  
Vol 34 (3) ◽  
pp. 599-606 ◽  
Author(s):  
Ginette Thibault-Halman ◽  
Carly S. Rivers ◽  
Christopher S. Bailey ◽  
Eve C. Tsai ◽  
Brian Drew ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Clinical Trials ◽  
National Registry ◽  
Acute Spinal Cord Injury ◽  
Registry Data ◽  
Cord Injury ◽  
National Registry Data

Current status of clinical trials for acute spinal cord injury

Injury ◽  
2005 ◽  
Vol 36 (2) ◽  
pp. S113-S122 ◽  
Author(s):  
Michael G Fehlings ◽  
Darryl C Baptiste
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Clinical Trials ◽  
Acute Spinal Cord Injury ◽  
Current Status ◽  
Cord Injury

Progression of Neuropathic Pain after Acute Spinal Cord Injury: A Meta-Analysis and Framework for Clinical Trials

2019 ◽  
Vol 36 (9) ◽  
pp. 1461-1468 ◽  
Author(s):  
Freda M. Warner ◽  
Jacquelyn J. Cragg ◽  
Catherine R. Jutzeler ◽  
Nanna B. Finnerup ◽  
Lars Werhagen ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Clinical Trials ◽  
Neuropathic Pain ◽  
Meta Analysis ◽  
Acute Spinal Cord Injury ◽  
Cord Injury

Clinical Trials and Spinal Cord Injury: Challenges and Therapeutic Interventions

2017 ◽  
pp. 741-755
Author(s):  
Freda M. Warner ◽  
Jacquelyn J. Cragg ◽  
John D. Steeves ◽  
John L. K. Kramer
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Clinical Trials ◽  
Therapeutic Interventions ◽  
Cord Injury
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