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Trials / Completed

CompletedNCT02350894

Microstructural Changes in the Brain During Recovery After Mild Traumatic Brain Injury

Status
Completed
Phase
Study type
Observational
Enrollment
44 (actual)
Sponsor
University of Aarhus · Academic / Other
Sex
All
Age
18 Years – 30 Years
Healthy volunteers
Not accepted

Summary

This study examines the possible microstructural changes in the brain during recovery after mTBI using diffusion MRI.

Detailed description

This study is embedded in a larger randomized controlled trial (RCT) (ClinicalTrials.gov ID: NCT02337101) from which the subjects are recruited and will separately examine the possible microstructural changes in the brain during recovery after mild traumatic brain injury (mTBI) in subjects with ongoing symptoms more than 2 month after mTBI in both groups from the RCT. Several biomarkers and brain areas has been investigated as possible sites of injury after mTBI. The nature of the diffuse chronic post-concussion symptoms (PCS) makes corpus callosum (CC), thalamus (THA) and hippocampus (HIP) interesting because of their central position and connection to widespread motor, sensory and cognitive processes and other brain areas. In most prior studies conventional magnetic resonance imaging (MRI) has failed to detect pathology especially in the chronic phase after mTBI. Diffusional Kurtosis Imaging (DKI) and Diffusional Tensor Imaging (DTI) are more sensitive to microstructural changes and might serve as biomarkers in the brain after mTBI. We hypothesized that a change in symptoms (as measured by cognitive performance and self reported symptoms) will correlate with a change in microstructural changes (as measured with DKI) in thalamus, corpus callosum and hippocampus from baseline 2-6 month after mTBI to follow up 6 month after. Separate correlations will also be made for both treatment and control group within the cohort.

Conditions

Interventions

TypeNameDescription
BEHAVIORALGraded and behavevial theraphyGraded and behavevial theraphy

Timeline

Start date
2015-01-01
Primary completion
2018-02-01
Completion
2018-05-01
First posted
2015-01-30
Last updated
2018-05-24

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT02350894. Inclusion in this directory is not an endorsement.

Microstructural Changes in the Brain During Recovery After Mild Traumatic Brain Injury (NCT02350894) · Clinical Trials Directory