Spinal Cord TraumaNCT04211636
Autoimmunity And Immune Deficiency After Spinal Cord Injury: Association With Rehabilitation Outcomes
An observational study of Spinal Cord Trauma, run by Marcel Kopp, MD.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Trauma
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- Adult, Older adult
Study population: Participants from primary care clinics
Who may be able to join
- 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
- For Italian centers only: SCI-Treatment using Methylprednisolone (according to NASCIS).
Who cannot join
- 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
Show all 12Show fewer
- 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).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Maladaptive Systemic Immune Response After Spinal Cord Injury: Humoral Post-traumatic Autoimmunity Against Central and Peripheral Nervous System Antigens in Association With Neurogenous Immune Depression as a Confounder of Rehabilitation
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.
- Conditions
- Spinal Cord Trauma
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Complete SCI, AIS A | Patients with complete spinal cord injury (AIS A) | |
| Incomplete SCI, AIS B, C, D | Patients with incomplete spinal cord injury (AIS B, C, D) | |
| Vertebral injuries without SCI | Patients with vertebral injuries without spinal cord injury (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-traumatic autoimmunity
Prevalence of autoantibodies against central and peripheral nervous system antigens in cerebrospinal fluid and serum
Measured: 3 months (10-14 weeks) post injury
Secondary outcomes (23)
International Standards for Neurological Classification of SCI - Upper Extremity Motor Score
Minimum 0, maximum 50; higher scores mean a better outcome
Measured: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
International Standards for Neurological Classification of SCI - Lower Extremity Motor Score
Minimum 0, maximum 50; higher scores mean a better outcome
Measured: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
International Standards for Neurological Classification of SCI - Sensory light touch score
Minimum 0, maximum 112; higher scores mean a better outcome
Measured: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
International Standards for Neurological Classification of SCI - Sensory pin prick score
Minimum 0, maximum 112; higher scores mean a better outcome
Measured: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
American Spinal Injury Association Impairment Scale
Ordinal alphabetical scale. Range A to E. Change in the scale to one of the subsequent letters in the alphabet means a better outcome.
Measured: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Spinal Cord Independence Measure III
Composite instrument for the assessment of physical independence; minimum 0, maximum 100; higher scores mean a better outcome
Measured: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Walking Index for Spinal Cord Injury II
Score for walking ability; minimum 0, maximum 20; higher scores mean a better outcome
Measured: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
10m-walk-test
Time in seconds required for 10 meter walking; higher scores mean a worse outcome
Measured: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Timed-up-and go
Time in seconds needed to raise from a chair, walk a distance of 3 m, turn back and sit down again; higher scores mean a worse outcome
Measured: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
6-minutes-walk-test
Walking distance in meters covered in 6 minutes; higher scores mean a better outcome
Measured: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Neuropathic Pain Scale 10
Instrument comprising 10 numeric analogue scales for intensity and qualities of pain; each item ranges from 0-10; higher scores mean a worse outcome
Measured: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Spinal Cord Injury Pain Basic Dataset
Composite instrument for the assessment of pain locations, type and intensity
Measured: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Modified Ashworth Scale
Assessment of muscle tone and resistance to passive motion; minimum 0, maximum 4, higher scores mean a worse outcome
Measured: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Penn spasm frequency scale
Patient rated frequency of spasms; minimum 0, maximum 4; higher scores mean a worse outcome
Measured: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Somatosensory evoked potentials
Tibial nerve and ulnar nerve; response is graded as ranging from 1=abolished to 4=normal response; higher scores mean better outcome
Measured: 2 weeks, 3 months
Motor evoked potentials
Anterior tibial muscle, abductor hallucis, abductor digiti minimi; response is graded as ranging from 1=abolished to 4=normal response; higher scores mean better outcome
Measured: 2 weeks, 3 months
Electroneurography
Abductor hallucis and abductor digiti minimi; latency, amplitude and F-waves
Measured: 2 weeks, 3 months
Sympathetic skin response
Skin response at palm and sole
Measured: 2 weeks, 3 months
Human Leukocyte Antigen - DR isotype expression on monocytes
Anti-Human Leukocyte Antigen - DR isotype antibodies bound per monocyte, higher values mean better outcome
Measured: 1 day, 3 days, 1week, 2 weeks, 3-6 weeks, 3 months, 6 months, 1 year post injury
Immune phenotyping
Panel of T-lymphocyte and B-lymphocyte subpopulations
Measured: 1 day, 3 days, 1week, 2 weeks, 3-6 weeks, 3 months, 6 months, 1 year post injury
Functional immune assays
White blood cell ex-vivo stimulation
Measured: 1 day, 3 days, 1week, 2 weeks, 3-6 weeks, 3 months, 6 months, 1 year post injury
Damage Associated Molecular Patterns
Immunoassays in plasma and CSF
Measured: 1week, 3 months,
Markers of Ferroptosis
Immunoassays in plasma and CSF
Measured: 1week, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study startOct 2023 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord TraumaStudies 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
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marcel Kopp, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation Wings For Life, University Hospital Tuebingen, Unfallkrankenhaus Berlin, Balgrist University Hospital, I.R.C.C.S. Fondazione Santa Lucia, University of Zurich, Medical University of Vienna, Ruhr University of Bochum, Swiss Federal Institute of Technology, King's College London, McGill University Health Centre/Research Institute of the McGill University Health Centre, Ohio State University
- Responsible party
- Sponsor-investigator, Marcel Kopp, MD, Charite University, Berlin, Germany
- Investigators
- Jan M Schwab, MD, PhD, Study chair, Ohio State UniversityMarcel A Kopp, MD, Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211636
- Sponsor's protocol ID
- SCIentinel-prolong
- Status last verified
- Feb 2023
- First submitted
- 20 Dec 2019
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maladaptive Systemic Immune Response After Spinal Cord Injury: Humoral Post-traumatic Autoimmunity Against Central and Peripheral Nervous System Antigens in Association With Neurogenous Immune Depression as a Confounder of Rehabilitation
- ClinicalTrials.gov ID
- NCT04211636
- Acronym / sponsor ID
- SCIentinel-prolong
- Conditions
- Spinal Cord Trauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Marcel Kopp, MDUniversity, hospital or other
- Collaborators
- Foundation Wings For Life, University Hospital Tuebingen, Unfallkrankenhaus Berlin, Balgrist University Hospital, I.R.C.C.S. Fondazione Santa Lucia, University of Zurich, Medical University of Vienna, Ruhr University of Bochum, Swiss Federal Institute of Technology, King's College London, McGill University Health Centre/Research Institute of the McGill University Health Centre, Ohio State University
- Study start
- Oct 2023 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 26 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Complete SCI, AIS A | – | –Patients with complete spinal cord injury (AIS A) |
| Incomplete SCI, AIS B, C, D | – | –Patients with incomplete spinal cord injury (AIS B, C, D) |
| Vertebral injuries without SCI | – | –Patients with vertebral injuries without spinal cord injury (control) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants from primary care clinics
Key inclusion criteria (2 listed)
- 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
- For Italian centers only: SCI-Treatment using Methylprednisolone (according to NASCIS).
Key exclusion criteria (12 listed)
- Non-traumatic SCI
- Severe multiple trauma
- Serious traumatic brain injury
- Pre-exiting neurological diseases
- Malignant Neoplasia, except in complete remission for 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post-traumatic autoimmunity
Time frame: 3 months (10-14 weeks) post injury
Prevalence of autoantibodies against central and peripheral nervous system antigens in cerebrospinal fluid and serum
23 secondary outcomes
International Standards for Neurological Classification of SCI - Upper Extremity Motor Score
Time frame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
International Standards for Neurological Classification of SCI - Lower Extremity Motor Score
Time frame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
International Standards for Neurological Classification of SCI - Sensory light touch score
Time frame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
International Standards for Neurological Classification of SCI - Sensory pin prick score
Time frame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
American Spinal Injury Association Impairment Scale
Time frame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Spinal Cord Independence Measure III
Time frame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Walking Index for Spinal Cord Injury II
Time frame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
10m-walk-test
Time frame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Timed-up-and go
Time frame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
6-minutes-walk-test
Time frame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Neuropathic Pain Scale 10
Time frame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Spinal Cord Injury Pain Basic Dataset
Time frame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Modified Ashworth Scale
Time frame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Penn spasm frequency scale
Time frame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Somatosensory evoked potentials
Time frame: 2 weeks, 3 months
Motor evoked potentials
Time frame: 2 weeks, 3 months
Electroneurography
Time frame: 2 weeks, 3 months
Sympathetic skin response
Time frame: 2 weeks, 3 months
Human Leukocyte Antigen - DR isotype expression on monocytes
Time frame: 1 day, 3 days, 1week, 2 weeks, 3-6 weeks, 3 months, 6 months, 1 year post injury
Immune phenotyping
Time frame: 1 day, 3 days, 1week, 2 weeks, 3-6 weeks, 3 months, 6 months, 1 year post injury
Functional immune assays
Time frame: 1 day, 3 days, 1week, 2 weeks, 3-6 weeks, 3 months, 6 months, 1 year post injury
Damage Associated Molecular Patterns
Time frame: 1week, 3 months,
Markers of Ferroptosis
Time frame: 1week, 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan M Schwab, MD, PhD study chair
Ohio State University
Marcel A Kopp, MD study director
Charite University, Berlin, Germany
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Trauma, run by Marcel Kopp, MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcel A Kopp, MD (+49 30 450560075, marcel.kopp@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-traumatic autoimmunity (time frame: 3 months (10-14 weeks) post injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.