Autoantibodies on Spinal Cord Injury
- Conditions
- Spinal Cord Injuries
- Registration Number
- NCT02493543
- Lead Sponsor
- Hospital Nacional de Parapléjicos de Toledo
- Brief Summary
The purpose of this study is to determine the autoantibody profiles after spinal cord injury and their role in spontaneous functional recovery.
- Detailed Description
Most patients experience variable degrees of functional recovery after spinal cord injury (SCI), predominantly in the first months after lesion. In SCI animal models, autoantibodies are pathogenic and their titers rise up at the time when spontaneous recovery stops. The aim of this study is to determine the autoantibody profiles after SCI and to infer their relation with functional recovery. To achieve this, autoantibody profiles, biochemical, hematological and immune-related parameters (cytokines, chemokines and growth factors) will be determined from a serum blood sample and functional recovery will be evaluated accordingly to standardized scales.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 110
- Traumatic or non-progressive vascular SCI
- Less than 45 days after lesion
- Any neurological level
- Complete and incomplete lesions
- If patient has been treated with glucocorticoids, it should have passed at least 7 days from the end of the treatment
- Cauda equina syndrome
- Autoimmune disorder
- Tumor (even if benign)
- Neurodegenerative disease
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in ASIA scores 4 months
- Secondary Outcome Measures
Name Time Method Change in neurological level of injury 4 months Change in ASIA impairment scale (AIS) 4 months
Trial Locations
- Locations (2)
Berufsgenossenschaftliche Unfallklinik Murnau
🇩🇪Murnau Am Staffelsee, Germany
Hospital Nacional de Parapléjicos, SESCAM
🇪🇸Toledo, Spain
Berufsgenossenschaftliche Unfallklinik Murnau🇩🇪Murnau Am Staffelsee, Germany