The purpose of the NISCI trial is to test if an antibody therapy can improve movement and quality of life of tetraplegic patients. A previous trial showed this treatment is safe and well accepted. This current trial has been approved by the National Ethics Committee and Ministry of Health for all participating trial sites.
The NISCI clinical trial booklet includes rules about who can participate, like the age, gender, type and stage of a disease, and other medical information of the person wanting to participate. Not everyone with Spinal Cord Injury (SCI) can take part in the trial. If your doctor thinks that the NISCI trial might be right for you, he or she may ask if you want to take part. Many patients also look for research trials on their own through websites or support groups. Our NISCI website and patient flyer provide information just on the NISCI trial. With the self-questionnaire on our website, you can check if the NISCI trial is right for you or not? www.nisci-2020.eu.
Even if you have agreed to participate in NISCI, you may drop out at any time without any change to your standard medical care.
If accepted for the trial, a patient has to begin the new treatment within 4-28 days after injury. Six injections, trial drug or without trial drug (control group) will be given over 30 days and then 3 follow-up appointments will happen at about 1, 3 and 6 months post-injury to repeat trial related tests. The trial will not change your rehabilitation.
After a SCI, patients learn about where their SCI is (neurological level) and how severe it is (classification). Patients in the NISCI trial must have a neurological level in the cervical (neck) part of the spinal cord where there are 7 segments or vertebra (e.g. C1 to C7). NISCI patients can be classified as A, B, C, or D. This classification is called the ASIA Impairment Score (AIS). AIS A patients do not have feeling or muscle control in the last segments of the spinal cord (S4-5) or below their neurological level. AIS B patients have some feeling below their neurological level and in S4-5. AIS C patients have some feeling and muscle control below their neurological level and in S4-5. AIS D patients can feel and move their muscles in more than half of the segments below their neurological level and in S4-5.