About this trial
The OVERCOME-TBI project aims to collect multimodal data approximately 1-4 and 11-14 years after an earlier well-documented traumatic brain injury (TBI) and examine factors that influence disease progression in order to gain new scientific insights into the long-term pathophysiology of TBI and identify new therapeutic targets.
TBIs are among the most serious health problems worldwide and represents a significant burden for the injured, their families and society. It is estimated that more than 50 million people in the world suffer a TBI every year and half of all people will suffer a TBI in their lifetime. TBI diagnostics has lagged significantly behind that of many other diseases. The current methods for assessing severity and predicting outcomes are based only on initial stage variables, and there are no objective tools for monitoring disease progression. The current acute severity indices have shown only a modest association with outcome, particularly in patients with mTBI. However, even in patients with moderate-severe TBI, clinical predictors and imaging together explain only 35% of the variance in outcomes.
In the OVERCOME-TBI project, patients with a history of TBI sustained 1-4 and 11-14 years earlier will undergo extensive neurological, biochemical, microbiological, gastroenterological and imaging examinations. The patients have previously participated in the prospective studies of our research group, so that data on acute injuries, blood-based biomarkers and advanced imaging results are already available. The results are expected to yield objective diagnostic and treatment methods for the diagnosis of progressive brain disease after brain injury and for the identification of microbiome-gut-brain axis dysfunction associated with disease progression.
Eligibility criteria
Qualifiers
All those who are alive and give their consent will be included from our previous prospective studies (TBIcare or PACoS-TBI)
Disqualifiers
For patients with TBI there are no exclusion criteria, and all eligible patients who give consent will be recruited
Those patients and controls with contraindication for head MRI (MRI-incompatible heart pacemaker, weight over 200 kg, mechanical heart valve prosthesis, first trimester of pregnancy, orbital area tattoo) will not undergo head MRI. Instead, they we will undergo the other assessments
For controls, those who have suffered a TBI or any other brain disorder after the TBIcare or PACoS-TBI study will be excluded.
Diagnosis of IBD or other diagnosis besides IBS causing severe GI symptoms, such as microscopic colitis or bile acid diarrhea
Trial design
Treatments tested in this trial
- blood-based protein biomarker assessments
- blood-based metabolomic/lipidomic biomarker assessments
- Diffusion-weighted magnetic resonance imaging (brain)
- Structural magnetic resonance imaging (brain)
- PET imaging (brain)
- Standard colonoscopy with pinch biopsies
- Fecal microbiome assessments
Treatment groups
Locations
Sponsors and collaborators
Turku University Hospital
Lead sponsor
Aalto University
Collaborator
University of Geneva, Switzerland
Collaborator
Göteborg University
Collaborator
University of Cambridge
Collaborator
Örebro University, Sweden
Collaborator
University of Turku
Collaborator