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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Graded and behavevial theraphy | Graded 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.