Cerebral Microstructural Changes Following Mild Traumatic Brain Injury

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

Study Overview

• Status: Completed
• Conditions: Brain Concussion

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Denmark
  • Hammel, Denmark, 8450
    • Region Hospital Hammel Neurocenter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Mild traumatic brain injury subjects with and without symptoms 3-4 months after trauma

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
MTBI SYMP; Mild Traumatic Brain Injury subjects with symptoms
MTBI NO SYMP; Mild Traumatic Brain Injury subjects without symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diffusion kurtosis Imaging (DKI)	MRI measurement unit	2-5 month after mTBI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diffusion Tensor Imaging (DTI)	MRI measurement unit	2-5 month after mTBI

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms	Questionnaire	2-5 month after mTBI
Cognitive performance	Interview and computer test	2-5 month after mTBI

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Erhard T Næss-Schmidt, PhD fellow, University of Aarhus

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: December 23, 2014
• First Submitted That Met QC Criteria: January 4, 2015
• First Posted (Estimate): January 6, 2015

Study Record Updates

• Last Update Posted (Estimate): October 26, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: mtbi-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO