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Autoantibodies on Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT02493543
Recruitment Status : Active, not recruiting
First Posted : July 9, 2015
Last Update Posted : February 23, 2018
Sponsor:
Collaborator:
Fundación Mutua Madrileña
Information provided by (Responsible Party):
Dr. Angel Arevalo Martin, 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.

Condition or disease Intervention/treatment
Spinal Cord Injuries Other: Blood collection

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.

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Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Role of Autoantibodies in Spontaneous Functional Recovery After Spinal Cord Injury
Actual Study Start Date : October 17, 2014
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Changes in ASIA scores [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Change in neurological level of injury [ Time Frame: 4 months ]
  2. Change in ASIA impairment scale (AIS) [ Time Frame: 4 months ]

Other Outcome Measures:
  1. Spinal cord independence measure (SCIM) [ Time Frame: Until discharge from the hospital (6-12 months) ]

Biospecimen Retention:   Samples Without DNA
Blood serum


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with acute spinal cord injury admitted to the Spanish National Hospital for Paraplegics
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02493543


Locations
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Germany
Berufsgenossenschaftliche Unfallklinik Murnau
Murnau Am Staffelsee, Germany
Spain
Hospital Nacional de Parapléjicos, SESCAM
Toledo, Spain
Sponsors and Collaborators
Hospital Nacional de Parapléjicos de Toledo
Fundación Mutua Madrileña
Investigators
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Principal Investigator: Angel Arevalo-Martin, PhD Hospital Nacional de Parapléjicos, SESCAM

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Responsible Party: Dr. Angel Arevalo Martin, Ph.D., Hospital Nacional de Parapléjicos de Toledo
ClinicalTrials.gov Identifier: NCT02493543     History of Changes
Other Study ID Numbers: FMM14
First Posted: July 9, 2015    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018

Keywords provided by Dr. Angel Arevalo Martin, Hospital Nacional de Parapléjicos de Toledo:
autoantibodies

Additional relevant MeSH terms:
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Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Autoantibodies
Immunologic Factors
Physiological Effects of Drugs