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Completed

NCT Number: NCT02331901

Cerebral Microstructural Changes Following Mild Traumatic Brain Injury

This study examine the possible microstructural changes in the middle brain 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

There is a need for clinical and biological markers at 2-3 month to screen people in risk of getting chronic post-concussion symptoms (PCS) but also biomarkers in the brain to find out if this group with prolonged symptoms has measurable changes in the brain which could explain the persisting symptoms.

Several biomarkers and brain areas have been investigated as possible sites of injury after mild traumatic brain injury (mTBI). The nature of the diffuse 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 later phase. Diffusional Kurtosis Imaging (DKI) and Diffusional Tensor Imaging (DTI) are more sensitive to microstructural changes and might serve as biomarkers in the middle brain after mTBI.

It is hypothesized that there will be a difference in the microstructure of the thalamus, corpus callosum and hippo campus as measured with DKI between two groups of mTBI subjects with and without PCS. Secondary it is hypothesized that DKI are more sensitive than DTI in the measure of microstructural changes.

Who can participate

Healthy volunteers accepted: Yes

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 2-5 months. The criteria are based 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 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 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. Patients with out symptoms (controls) having no problems on the RPQ.

Exclusion criteria

  • 1. Objective neurological findings from neurological examination and / or acute trauma CT scan, indicating neurological disease or brain damage.
  • Previous concussion leading to persistent PCS within the last two years.
  • Severe misuse 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 (life time), multiple sclerosis etc..
  • Suitable for MRI examination

Treatment and study plan

Primary outcomes

  1. Diffusion kurtosis Imaging (DKI)

    Time frame: 2-5 month after mTBI

    MRI measurement unit

Secondary outcomes

  1. Diffusion Tensor Imaging (DTI)

    Time frame: 2-5 month after mTBI

    MRI measurement unit

Other outcomes

  1. Symptoms

    Time frame: 2-5 month after mTBI

    Questionnaire

  2. Cognitive performance

    Time frame: 2-5 month after mTBI

    Interview and computer test

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 6, 2015
Registry last updated
Oct 26, 2016

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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