Autoantibodies on Spinal Cord Injury

NCT ID: NCT02493543

Last Updated: 2018-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-17

Study Completion Date

2018-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Spinal Cord Injuries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Blood collection

Intervention Type OTHER

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.

Blood collection

Intervention Type OTHER

Blood collection from the subject's arm

Interventions

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Blood collection

Blood collection from the subject's arm

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundación Mutua Madrileña

OTHER

Sponsor Role collaborator

Hospital Nacional de Parapléjicos de Toledo

OTHER

Sponsor Role lead

Responsible Party

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Dr. Angel Arevalo Martin

Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Angel Arevalo-Martin, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Nacional de Parapléjicos, SESCAM

Locations

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Berufsgenossenschaftliche Unfallklinik Murnau

Murnau am Staffelsee, , Germany

Site Status

Hospital Nacional de Parapléjicos, SESCAM

Toledo, , Spain

Site Status

Countries

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Germany Spain

References

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Leister I, Altendorfer B, Maier D, Mach O, Wutte C, Grillhosl A, Arevalo-Martin A, Garcia-Ovejero D, Aigner L, Grassner L. Trajectory of Serum Levels of Glial Fibrillary Acidic Protein Within Four Weeks Post-Injury Is Related to Neurological Recovery During the Transition from Acute to Chronic Spinal Cord Injury. J Neurotrauma. 2023 May;40(9-10):999-1006. doi: 10.1089/neu.2022.0326. Epub 2022 Dec 9.

Reference Type DERIVED
PMID: 36200629 (View on PubMed)

Other Identifiers

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FMM14

Identifier Type: -

Identifier Source: org_study_id

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