Clinical trial NCT05235802: Long-term Follow-up in Severe Traumatic Brain Injury
Official title: Long-term Follow-up in Severe Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Traumatic Brain Injury
Neurodegenerative Diseases
Chronic Traumatic Encephalopathy
Keywords: Fluid biomarkers
Neuroinflammatory process
Auto-immunity
Structural imaging
Clinical assessment
Long-term follow-up
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2022-02-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients that had suffered a traumatic brain injury and registered at our local trauma database will be sent a letter asking them for participation.

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).


Eligibility criteria: Inclusion Criteria:

* Having suffered a traumatic brain injury and being treated at the Karolinska University Hospital between 2007 and 2015.
* Age \>18 years of age

Exclusion Criteria:

- Pregnancy

Primary outcomes:
measure: GOSE vs structural outcome
timeFrame: Assessed at the chronic time-point (10-15 years after injury).
measure: Barthel Index vs structural outcome
timeFrame: Assessed at the chronic time-point (10-15 years after injury).
measure: Fatigue Severity Scale vs structural outcome
timeFrame: Assessed at the chronic time-point (10-15 years after injury).
measure: MOCA vs structural outcome
timeFrame: Assessed at the chronic time-point (10-15 years after injury).
measure: SF-36 vs structural outcome
timeFrame: Assessed at the chronic time-point (10-15 years after injury).
measure: EQ-5D vs structural outcome
timeFrame: Assessed at the chronic time-point (10-15 years after injury).
measure: MADRS vs structural outcome
timeFrame: Assessed at the chronic time-point (10-15 years after injury).
measure: Structural outcome vs proteomic markers in serum
timeFrame: Assessed at the chronic time-point (10-15 years after injury).
measure: Structural outcome vs proteomic markers in cerebrospinal fluid
timeFrame: Assessed at the chronic time-point (10-15 years after injury).
measure: Structural outcome vs auto-antibodies in serum
timeFrame: Assessed at the chronic time-point (10-15 years after injury).
Secondary outcomes:
measure: Acute vs chronic comparisons of proteomic markers in serum
timeFrame: From samples acquired in the acute phase (first weeks after injury) with samples acquired in the chronic phase (10-15 years after injury)
measure: Acute vs chronic comparisons of proteomic markers in CSF
timeFrame: From samples acquired in the acute phase (first weeks after injury) with samples acquired in the chronic phase (10-15 years after injury)
measure: Acute vs chronic comparisons of autoantibodies
timeFrame: From samples acquired in the acute phase (first weeks after injury) with samples acquired in the chronic phase (10-15 years after injury)
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
References: