Long-term Follow-up in Severe Traumatic Brain Injury (LONG-TBI)

Karolinska University Hospital

Status: Enrolling

Conditions: Traumatic Brain Injury; Neurodegenerative Diseases; Chronic Traumatic Encephalopathy

Treatments: Diagnostic Test: Clinical assessments / questionnaires; Diagnostic Test: Blood sampling (serum/plasma preparation); Diagnostic Test: Magnetic Resonance Imaging (MRI) (including functional MRI); Diagnostic Test: Cerebrospinal fluid (CSF)

Study type: Observational

Funder types: Other

Identifiers

NCT05235802

4-1857 /2021 (Other Identifier)

2021-02010

K 2021-5631 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Patients with traumatic brain injury about 10 years ago

Description:

Patients that had suffered a TBI and being managed at the Neurosurgical Department at the Karolinska University Hospital between 2007 and 2015.

Treatment:

Diagnostic Test: Blood sampling (serum/plasma preparation)

Diagnostic Test: Clinical assessments / questionnaires

Diagnostic Test: Magnetic Resonance Imaging (MRI) (including functional MRI)

Diagnostic Test: Cerebrospinal fluid (CSF)