Autoantibodies on Spinal Cord Injury

February 22, 2018 updated by: Dr. Angel Arevalo Martin, Hospital Nacional de Parapléjicos de Toledo

Role of Autoantibodies in Spontaneous Functional Recovery After Spinal Cord Injury

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Murnau Am Staffelsee, Germany
        • Berufsgenossenschaftliche Unfallklinik Murnau
  • Spain
      • Toledo, Spain
        • Hospital Nacional de Parapléjicos, SESCAM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with acute spinal cord injury admitted to the Spanish National Hospital for Paraplegics

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Spinal cord injury
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.
Other: Blood collection
Blood collection from the subject's arm
Controls
Control subjects (n=20) will undergo a common arm blood collection to determine autoantibody profiles in serum. This procedure will be performed only once.
Other: Blood collection
Blood collection from the subject's arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in ASIA scores
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in neurological level of injury
Time Frame: 4 months
4 months
Change in ASIA impairment scale (AIS)
Time Frame: 4 months
4 months

Other Outcome Measures

Outcome Measure
Time Frame
Spinal cord independence measure (SCIM)
Time Frame: Until discharge from the hospital (6-12 months)
Until discharge from the hospital (6-12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Nacional de Parapléjicos de Toledo

Collaborators

Fundación Mutua Madrileña

Investigators

  • Principal Investigator: Angel Arevalo-Martin, PhD, Hospital Nacional de Parapléjicos, SESCAM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 17, 2014

Primary Completion (ANTICIPATED)

April 1, 2018

Study Completion (ANTICIPATED)

April 1, 2018

Study Registration Dates

First Submitted

July 7, 2015

First Submitted That Met QC Criteria

July 7, 2015

First Posted (ESTIMATE)

July 9, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 23, 2018

Last Update Submitted That Met QC Criteria

February 22, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMM14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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