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

Brain Concussion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02350894
• Other study ID #: 1-10-72-139-14
• Status: Completed
• Start date: January 2015
• Est. completion date: May 1, 2018

Study information

• Verified date: October 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 1, 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• 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 2-6 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.

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic

Intervention

Behavioral:
• Graded and behavevial theraphy
Graded and behavevial theraphy

Locations

Country	Name	City	State
Denmark	Region Hospital Hammel Neurocenter	Hammel

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, Regionshospitalet Hammel Neurocenter

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microstructural changes in the thalamus, corpus callosum and hippocampus between baseline and follow up, as measured by Diffusion kurtosis imaging (DKI)	MRI measurement	Baseline 2-6 month after mTBI with follow up 6 month after
Secondary	Microstructural changes in the thalamus, corpus callosum and hippocampus from baseline to follow up, as measured by Diffusion tensor imaging (DTI)	MRI measurement	Baseline 2-6 month after mTBI with follow up 6 month after
Secondary	Change in post-concussion symptoms from baseline to follow up, as measured by Rivermead post-concussion questionnaire (RPQ) and headache (VAS scale)	Symptom score	Baseline 2-6 month after mTBI with follow up 6 month after
Secondary	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	Cognitive test battery	Baseline 2-6 month after mTBI with follow up 6 month after

External Links

•   Center of Functionally Integrative Neuroscience, Aarhus University, Aarhus University Hospital
•   Hammel Neurorehabilitation Centre and University Research Clinic, Aarhus University
•   The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital