Brain Concussion Clinical Trial
Official title:
Cerebral Microstructural Changes Following Mild Traumatic Brain Injury
This study examine the possible microstructural changes in the middle brain after mTBI using diffusion MRI
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 |
Observational Model: Case Control, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Denmark | Region Hospital Hammel Neurocenter | Hammel |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
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 |
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