Study Results
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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UNKNOWN
100 participants
OBSERVATIONAL
2021-10-01
2025-01-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with traumatic brain injury about 10 years ago
Patients that had suffered a TBI and being managed at the Neurosurgical Department at the Karolinska University Hospital between 2007 and 2015.
Magnetic Resonance Imaging (MRI) (including functional MRI)
Patients will undergo magnetic resonance imaging including the following protocols:
* 3D T1w MPRAGE
* 3D T2w FLAIR SPACE
* 3D T2w SPACE
* 3D T1w PSIR (cortical visualization)
* 2D synthetic MRI (quantitative T1, T2, PD and myelin quantification)
* Resting-state fMRI (6 min, human connectome protocol, 2 mm iso)
* 3D SWI
* DWI b1000 32 directions and b3000 64 directions.
Blood sampling (serum/plasma preparation)
Blood will be screened for genetic modifications. Serum will be analyzed for auto-antibodies and other inflammatory and neurodegenerative biomarkers.
Cerebrospinal fluid (CSF)
CSF will be analyzed for inflammatory and neurodegenerative biomarkers.
Clinical assessments / questionnaires
* Glasgow Outcome Scale Extended (functional outcome)
* Short-Form 36 (quality of life),
* EQ-5D (quality of life),
* Mini-Mental State Extended (MMSE) (mental state assessment).
* Barthel Index (daily living disabilities),
* Montgomery-Åsberg Depression Score (MADRS-S) (level of depression)
* Fatigue Severity Scale (FSS) (level of fatigue)
Other than that, neurological assessments focusing on the Unified Parkinson's Disease Rating Scale (UPDRS) will be performed.
Interventions
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Magnetic Resonance Imaging (MRI) (including functional MRI)
Patients will undergo magnetic resonance imaging including the following protocols:
* 3D T1w MPRAGE
* 3D T2w FLAIR SPACE
* 3D T2w SPACE
* 3D T1w PSIR (cortical visualization)
* 2D synthetic MRI (quantitative T1, T2, PD and myelin quantification)
* Resting-state fMRI (6 min, human connectome protocol, 2 mm iso)
* 3D SWI
* DWI b1000 32 directions and b3000 64 directions.
Blood sampling (serum/plasma preparation)
Blood will be screened for genetic modifications. Serum will be analyzed for auto-antibodies and other inflammatory and neurodegenerative biomarkers.
Cerebrospinal fluid (CSF)
CSF will be analyzed for inflammatory and neurodegenerative biomarkers.
Clinical assessments / questionnaires
* Glasgow Outcome Scale Extended (functional outcome)
* Short-Form 36 (quality of life),
* EQ-5D (quality of life),
* Mini-Mental State Extended (MMSE) (mental state assessment).
* Barthel Index (daily living disabilities),
* Montgomery-Åsberg Depression Score (MADRS-S) (level of depression)
* Fatigue Severity Scale (FSS) (level of fatigue)
Other than that, neurological assessments focusing on the Unified Parkinson's Disease Rating Scale (UPDRS) will be performed.
Eligibility Criteria
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Inclusion Criteria
* Age \>18 years of age
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Karolinska University Hospital
OTHER
Responsible Party
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Eric Thelin
Principal Investigator (MD, PhD), Associate Professor
Locations
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Karolinska University Hospital
Stockholm, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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4-1857 /2021
Identifier Type: OTHER
Identifier Source: secondary_id
K 2021-5631
Identifier Type: OTHER
Identifier Source: secondary_id
2021-02010
Identifier Type: -
Identifier Source: org_study_id
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