Autoantibodies on Spinal Cord Injury

Hospital Nacional de Parapléjicos de Toledo

Status: Unknown

Conditions: Spinal Cord Injuries

Treatments: Other: Blood collection

Study type: Observational

Funder types: Other

Identifiers

NCT02493543

FMM14

Details and patient eligibility

About

The purpose of this study is to determine the autoantibody profiles after spinal cord injury and their role in spontaneous functional recovery.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: 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

Trial design

110 participants in 2 patient groups

Spinal cord injury

Description:

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.

Treatment:

Other: Blood collection

Controls

Description:

Control subjects (n=20) will undergo a common arm blood collection to determine autoantibody profiles in serum. This procedure will be performed only once.

Treatment:

Other: Blood collection