Long-term Follow-up in Severe Traumatic Brain Injury
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Traumatic Brain Injury
- Sponsor
- Karolinska University Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Structural outcome vs auto-antibodies in serum
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
The underlying pathophysiology following traumatic brain injury (TBI) in how different neurodegenerative conditions are developed are still unknown. Different neuroinflammatory and neurodegenerative pathways have been suggested.
The goal of this study is to follow-up patients that have been treated for TBI at the neurosurgical department about 10-15 years after their initial injury, in order to analyze fluid biomarkers of inflammation, injury and degeneration and associate these with structural imaging and long-term functional outcome.
The investigators aim to invite about 100 patients back and perform advanced magnetic resonance imaging protocols, sample cerebrospinal fluid and blood for different bio- and inflammatory markers, study genetic modifications and associate it with outcomes being assessed through questionnaires.
The investigators' hypothesis is that patients with ongoing inflammatory processes will present with more fluid biomarkers of neurodegeneration, worse clinical presentation and also more structural/atrophic signs on imaging. This will result in an increased understanding of the interplay between neuroinflammation and neurodegeneration in chronic TBI, as well as a panel of tentative biomarkers that could be used to assess level of disability following TBI and chronic traumatic encephalopathy (CTE).
Investigators
Eric Thelin
Principal Investigator (MD, PhD), Associate Professor
Karolinska University Hospital
Eligibility Criteria
Inclusion Criteria
- •Having suffered a traumatic brain injury and being treated at the Karolinska University Hospital between 2007 and
- •Age \>18 years of age
Exclusion Criteria
- •Pregnancy
Outcomes
Primary Outcomes
Structural outcome vs auto-antibodies in serum
Time Frame: Assessed at the chronic time-point (10-15 years after injury).
Alterations at axonal and myelin integrity as assessed by magnetic resonance imaging will be associated with a panel of auto-antibodies targeting central nervous system antigens ((affected voxels vs antibody titers)
MADRS vs structural outcome
Time Frame: Assessed at the chronic time-point (10-15 years after injury).
Montgomery-Åsberg depression rating scale (MADRS) will be associated with alterations at axonal and myelin integrity as assessed by magnetic resonance imaging (MADRS score vs affected voxels).
EQ-5D vs structural outcome
Time Frame: Assessed at the chronic time-point (10-15 years after injury).
Health-related quality of life (EQ-5D) will be associated with alterations at axonal and myelin integrity as assessed by magnetic resonance imaging (EQ5D score vs affected voxels on MRI).
Fatigue Severity Scale vs structural outcome
Time Frame: Assessed at the chronic time-point (10-15 years after injury).
Fatigue Severity Scale (9-63) will be associated with alterations at axonal and myelin integrity as assessed by magnetic resonance imaging (affected voxels).
MOCA vs structural outcome
Time Frame: Assessed at the chronic time-point (10-15 years after injury).
Montreal Cognitive Assessment (MoCA) will be associated with alterations at axonal and myelin integrity as assessed by magnetic resonance imaging (MOCA score vs affected voxels).
Barthel Index vs structural outcome
Time Frame: Assessed at the chronic time-point (10-15 years after injury).
Barthel Index (0-100) will be associated with alterations at axonal and myelin integrity as assessed by magnetic resonance imaging (affected voxels).
SF-36 vs structural outcome
Time Frame: Assessed at the chronic time-point (10-15 years after injury).
Short-Form 36 will be associated with alterations at axonal and myelin integrity as assessed by magnetic resonance imaging (SF-36 score vs affected voxels on MRI).
GOSE vs structural outcome
Time Frame: Assessed at the chronic time-point (10-15 years after injury).
Glasgow Outcome Score extended (1-8) will be associated alterations at axonal and myelin integrity as assessed by magnetic resonance imaging (affected voxels).
Structural outcome vs proteomic markers in serum
Time Frame: Assessed at the chronic time-point (10-15 years after injury).
Alterations at axonal and myelin integrity as assessed by magnetic resonance imaging will be associated with a proteomic profiling using a targeted antibody array of about 30 proteins of inflammatory and neurodegenerative origin (affected voxels vs mean fluorescent intensities (MFI)).
Structural outcome vs proteomic markers in cerebrospinal fluid
Time Frame: Assessed at the chronic time-point (10-15 years after injury).
Alterations at axonal and myelin integrity as assessed by magnetic resonance imaging will be associated with a proteomic profiling of cerebrospinal fluid using a targeted antibody array of about 30 proteins of inflammatory and neurodegenerative origin (affected voxels vs mean fluorescent intensities (MFI)).
Secondary Outcomes
- Acute vs chronic comparisons of proteomic markers in CSF(From samples acquired in the acute phase (first weeks after injury) with samples acquired in the chronic phase (10-15 years after injury))
- Acute vs chronic comparisons of autoantibodies(From samples acquired in the acute phase (first weeks after injury) with samples acquired in the chronic phase (10-15 years after injury))
- Acute vs chronic comparisons of proteomic markers in serum(From samples acquired in the acute phase (first weeks after injury) with samples acquired in the chronic phase (10-15 years after injury))