NCT05235802

Long-term Follow-up in Severe Traumatic Brain Injury

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Karolinska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Traumatic Brain Injury
• Neurodegenerative Diseases
• Chronic Traumatic Encephalopathy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	Cerebrospinal fluid (CSF)	CSF will be analyzed for inflammatory and neurodegenerative biomarkers.
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2021-10-01
• Primary completion: 2023-01-31
• Completion: 2025-01-31
• First posted: 2022-02-11
• Last updated: 2022-02-11

Locations

1 site across 1 country: Sweden