Spinal Cord Injury - Assessing Tolerability and Use of Combined Rehabilitation and NeuroAiD

A Case Series of Patients With Spinal Cord Injury Treated With Standard Therapies and NeuroAiD

SATURN investigates the promising role of NeuroAiD in patients with spinal cord injury and will provide important information on the feasibility of conducting larger controlled trials.

SATURN is a prospective cohort study of patients with moderately-severe to severe spinal cord injury, defined as American Spinal Injury Association Impairment Scale A and B, who are treated with open-label NeuroAiD for 6 months in addition to standard care and followed for 24 months. Anonymized data will be prospectively collected at baseline and months 1, 3, 6, 12, 18, and 24 using a secured online system and will include information on demographics, main diagnostics, neurological and functional state, treatment compliance, concomitant therapies, and side effects, if any.

Inclusion Criteria:

• Male or female
• Age 18 to 65 years
• Diagnosed with spinal cord injury between 3 days and 4 weeks
• American Spinal Injury Association Impairment Scale A or B
• Informed consent for inclusion into the database is obtained

Exclusion Criteria:

• Non survivable injury
• Multiple significant trauma (i.e. significant intracranial and extracranial injuries including limb fractures) that would limit observation of recovery from spinal cord injury
• Other conditions that would limit clinical assessment of outcomes (e.g. dementia, demyelinating disease, autoimmune disease, etc)
• Refusal of treatment or contraindication to NeuroAiD