Autoantibodies on Spinal Cord Injury

• Conditions: Spinal Cord Injuries
• Interventions: Other: Blood collection

• 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.

Study Timeline

• Study Start: 2014-10-17
• Study First Submitted: 2015-07-07
• Study First Submitted QC: 2015-07-07
• Study First Posted: 2015-07-09
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-22
• Last Update Posted: 2018-02-23
• Primary Completion: 2018-04
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	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.
Spinal cord injury	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.

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)

Hospital Nacional de Parapléjicos, SESCAM; 🇪🇸 Toledo, Spain

Berufsgenossenschaftliche Unfallklinik Murnau; 🇩🇪 Murnau Am Staffelsee, Germany