Spinal Cord InjuriesNCT02493543
Autoantibodies on Spinal Cord Injury
An observational study of Spinal Cord Injuries, run by Hospital Nacional de Parapléjicos de Toledo at 2 sites in 2 countries.
Trial summary
The purpose of this study is to determine the autoantibody profiles after spinal cord injury and their role in spontaneous functional recovery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Blood collection
- How many people
- 110 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 17 Oct 2014to 31 Dec 2020
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with acute spinal cord injury admitted to the Spanish National Hospital for Paraplegics
Who may be able to join
- 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
Who cannot join
- Cauda equina syndrome
- Autoimmune disorder
- Tumor (even if benign)
- Neurodegenerative disease
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Berufsgenossenschaftliche Unfallklinik Murnau
Murnau am Staffelsee
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Blood collection
- Keywords
- autoantibodies
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionOther
Blood collection from the subject's arm
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood collection | |
| 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. Receives: Other: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in ASIA scores
Measured: 4 months
Secondary outcomes (2)
Change in neurological level of injury
Measured: 4 months
Change in ASIA impairment scale (AIS)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study start17 Oct 2014
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Nacional de Parapléjicos de Toledo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Mutua Madrileña
- Responsible party
- Principal investigator, Dr. Angel Arevalo Martin, Hospital Nacional de Parapléjicos de Toledo
- Investigators
- Angel Arevalo-Martin, PhD, Principal investigator, Hospital Nacional de Parapléjicos, SESCAM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493543
- Sponsor's protocol ID
- FMM14
- Status last verified
- Oct 2026
- First submitted
- 7 Jul 2015
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36200629