Autoimmunity And Immune Deficiency After Spinal Cord Injury: Association With Rehabilitation Outcomes

Marcel Kopp, MD

Status

Not yet enrolling

Conditions

Spinal Cord Trauma

Study type

Observational

Funder types

Other

Identifiers

NCT04211636

SCIentinel-prolong

Details and patient eligibility

About

The SCIentinel-prolong study systematically analyzes humoral autoantibody responses and thier interaction with post-spinal cord injury (SCI) immune-deficiency and infections as well as their association with the clinical course of rehabilitation. Therefore, molecular and immunological tests in blood and cerebrospinal fluid specimen are combined with clinical outcomes ranging from neurological function, neuropathic pain and spasticity to walking tests and measures of independence in daily living within the first year after SCI. Including a control group with participants suffering from vertebral fractures without SCI allows to differentiate between neurological and general injury and treatment effects.

Enrollment

81 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Acute traumatic SCI, American Spinal Injury Association Impairment Scale (AIS) A to D, neurologic level of injury C3 - L2 or acute vertebral fracture without SCI
Inclusion within 21 days post-injury
For Italian centers only: SCI-Treatment using Methylprednisolone (according to NASCIS).

Exclusion criteria

Non-traumatic SCI
Severe multiple trauma
Serious traumatic brain injury
Pre-exiting neurological diseases
Malignant Neoplasia, except in complete remission for 5 years
Rheumatic diseases / collagenosis / vasculitis
Other autoimmune diseases
Pre-existing chronic infection
Severe alcohol or drug addiction
Pregnancy or lactation
Simultaneous participation in interventional clinical trials
For centers in Germany or Switzerland only: SCI-treatment using Methylprednisolone (according to NASCIS).