Cerebral Microstructural Changes Following Mild Traumatic Brain Injury

Brain Concussion Clinical Trial

Official title:

Cerebral Microstructural Changes Following Mild Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02331901
• Other study ID #: mtbi-1
• Status: Completed
• Phase: N/A
• First received: December 23, 2014
• Last updated: October 24, 2016
• Start date: December 2014
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial Summary

This study examine the possible microstructural changes in the middle brain after mTBI using diffusion MRI

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries

Locations

Country	Name	City	State
Denmark	Region Hospital Hammel Neurocenter	Hammel

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Symptoms	Questionnaire	2-5 month after mTBI	No
Other	Cognitive performance	Interview and computer test	2-5 month after mTBI	No
Primary	Diffusion kurtosis Imaging (DKI)	MRI measurement unit	2-5 month after mTBI	No
Secondary	Diffusion Tensor Imaging (DTI)	MRI measurement unit	2-5 month after mTBI	No