Spinal Cord Injury
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGNeuroAiD
Sponsors
Moleac Pte Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spinal cord injury severity based on American Spinal Injury Association Impairment Scale | 6 months | — |
| Motor recovery based on American Spinal Injury Association Impairment Scale motor score | 6 months | — |
| Number of patients experiencing adverse events | 6 months | Adverse events as individual events and according to organ system, severity, and relatedness |
Secondary
| Measure | Time frame |
|---|---|
| Functional state based on Spinal Cord Independence Measure | 1, 3, 6, 12, 18, 24 months |
| Spinal cord injury severity based on American Spinal Injury Association Impairment Scale | 1, 3, 12, 18, 24 months |
| Quality of life based on Short Form-8 Health Survey | 1, 3, 6, 12, 18, 24 months |
| Motor recovery based on American Spinal Injury Association Impairment Scale motor score | 1, 3, 12, 18, 24 months |
| Sensory recovery based on American Spinal Injury Association Impairment Scale sensory score | 1, 3, 6, 12, 18, 24 months |
Countries
Malaysia
Outcome results
None listed