Microstructural Changes in the Brain During Recovery After Mild Traumatic Brain Injury
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|ClinicalTrials.gov Identifier: NCT02350894|
Recruitment Status : Recruiting
First Posted : January 30, 2015
Last Update Posted : October 26, 2017
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Microstructural Changes in the Brain During Recovery After Mild Traumatic Brain Injury|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||February 2018|
mTBI subjects with ongoing symptoms
- Microstructural changes in the thalamus, corpus callosum and hippocampus between baseline and follow up, as measured by Diffusion kurtosis imaging (DKI) [ Time Frame: Baseline 2-6 month after mTBI with follow up 6 month after ]MRI measurement
- Microstructural changes in the thalamus, corpus callosum and hippocampus from baseline to follow up, as measured by Diffusion tensor imaging (DTI) [ Time Frame: Baseline 2-6 month after mTBI with follow up 6 month after ]MRI measurement
- Change in post-concussion symptoms from baseline to follow up, as measured by Rivermead post-concussion questionnaire (RPQ) and headache (VAS scale) [ Time Frame: Baseline 2-6 month after mTBI with follow up 6 month after ]Symptom score
- Change in Cognitive performance from baseline to follow up, as measured by executive function, verbal and visual memory, processing speed, working memory, Visuospatial perception and construction [ Time Frame: Baseline 2-6 month after mTBI with follow up 6 month after ]Cognitive test battery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02350894
|Contact: Erhard T Næss-Schmidt, PhD fellow||+45 email@example.com|
|Region Hospital Hammel Neurocenter||Recruiting|
|Hammel, Denmark, 8450|
|Contact: Erhard Næss-Schmidt, PhD fellow +45 78419062 firstname.lastname@example.org|
|Sub-Investigator: Erhard T Næss-Schmidt, PhD fellow|
|Principal Investigator: Jørgen F Nielsen, Professor|
|Principal Investigator:||Jørgen F Nielsen, Professor||Hammel Neurocenter - Universitetsklinik for Neurorehabilitering, Aarhus Universi|