Role of Autoantibodies in Spontaneous Functional Recovery After Spinal Cord Injury
| Registry | NCT02493543 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 110 (Estimated) |
| Sponsor | Hospital Nacional de Parapléjicos de Toledo (Other); collaborators: Fundación Mutua Madrileña |
| Conditions | Spinal Cord Injuries |
| Interventions | Blood collection (Other) |
| Dates | start 2014-10-17, primary completion 2020-12-31, completion 2020-12-31, first posted 2015-07-09, last updated 2026-10-21 |
| Locations | 2 sites in Germany, Spain |
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All trials for Spinal Cord Injuries All trials of Blood collection
The purpose of this study is to determine the autoantibody profiles after spinal cord injury and their role in spontaneous functional recovery.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Spinal cord injury | Other: Blood collection | Patients (n=90) will undergo a common arm blood collection to determine autoantibody profiles in serum. This procedure will be performed twice: after recruitment and 3 months later. | |
| Controls | Other: Blood collection | Control subjects (n=20) will undergo a common arm blood collection to determine autoantibody profiles in serum. This procedure will be performed only once. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Inclusion Criteria: * 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 Exclusion Criteria: * Cauda equina syndrome * Autoimmune disorder * Tumor (even if benign) * Neurodegenerative disease
| Facility | City | Country | Status |
|---|---|---|---|
| Berufsgenossenschaftliche Unfallklinik Murnau | Murnau am Staffelsee | Germany | |
| Hospital Nacional de Parapléjicos, SESCAM | Toledo | Spain |