Experimental Treatments for Spinal Cord Injury: What you Should Know.

Abstract

Cover image: photo montage shows a research scientist superimposed over a tri-coloured micrograph of spinal cord tissue. Section 1 Introduction: Why have we written this booklet? 10 Section 2 What are the chances that you will see some functional improvement after spinal cord injury (SCI) without a drug treatment or transplantation of cells? 11 • The ASIA scale 11 Section 3 What are the risks of undergoing a treatment that has not completed a valid clinical trials program or been approved by an appropriate regulatory agency? 13 Section 4 What is a clinical trial and what is the pre-clinical process for developing a therapeutic treatment for SCI 13 • Clinical trial phases 13 • Trial design 15 • Preclinical process 16 Section 5 What is ethical and unethical in the conduct of a clinical trial and what is informed consent? 18 • Informed consent 19 • Risks 19 Section 6 What can jeopardize the accurate interpretation of the outcomes for a clinical trial and what can be done to prevent this from happening? 20 • Bias 20 • Control subjects 20 • Blinded assessements 20 Section 7 How are functional benefits of an experimental treatment measured for SCI? 22 • Use of the ASIA Scale to measure changes in function 22 • Other tools for measuring changes in neurological function 23 • Functional tests 24 Section 8 If you participate in a clinical trial, how does it effect your participation in future SCI clinical trials? 25 Section 9 What are some of the current experimental treatments proposed for the treatment of SCI and at what stage are they in terms of their validation as beneficial? 25 • Selected experimental approaches for the treatment of SCI 27 Section 10 What should you ask before agreeing to take part in a clinical trial? Your participation checklist.