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Completed

NCT Number: NCT02350894

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

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

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Region Hospital Hammel Neurocenter

Hammel, 8450, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Concussion caused by a head trauma according to the diagnostic criteria recommended by the Danish Consensus Report on Commotio Cerebri within the last 2-6 months. The criteria are based on recommendations by the WHO Task Force, but with the amendment, that there must have been a direct contact between the head and an object in order to rule out pure acceleration - deceleration traumas.
  • Age 18 to 30 years at the time of the head trauma.
  • Able to understand, speak and read Danish.
  • Patients with symptoms on at least three items on the Rivermead Post Concussion Symptoms Questionnaire (RPQ) rated as moderate or severe problem. PCS have to be subjectively rated as causing substantial impairment in daily life.
  • Suitable for MRI examination

Exclusion criteria

  • Objective neurological findings from neurological examination and / or acute trauma CT scan, indicating other neurological diseases or brain damage.
  • Previous concussion leading to persistent PCS within the last two years.
  • Severe abuse of alcohol, prescription drugs and / or illegal drugs.
  • Psychiatric morbidity or severe neurological disease that impedes participation in the treatment, i.e. Bipolar Disorder, autism, psychotic disorder (lifetime), multiple sclerosis etc.

Treatment and study plan

Graded and behavevial theraphy

Behavioral

Graded and behavevial theraphy

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • Regionshospitalet Hammel Neurocenter

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 30, 2015
Registry last updated
May 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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