Multimodal Approach to Testing the Acute Effects of Mild Traumatic Brain Injury (mTBI)

Study Overview
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Brief Summary
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The objective of the study is to determine the relative roles for various testing modalities in the diagnosis and prognosis of mild traumatic brain injury.

Detailed Description
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Subjects will undergo functional brain testing (magnetoencephalography, electroencephalography), anatomical brain imaging (diffusion tensor imaging, susceptibility-weighted imaging), neuropsychological testing (memory, language, processing speed), sleep patterns using actigraphy, and blood testing of candidate biomarkers. Testing will be done at 3 time points post-injury: 1 day, 14 days, and 30 days post-injury. Analysis of these tests collectively will be used to develop diagnostic tools for acute mTBI.

Official Title
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Multimodal Approach to Testing the Acute Effects of Mild Traumatic Brain Injury (mTBI)

Conditions
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Concussion, Mild

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Civilian (non-military) presenting to HMH ED. Exclusion Criteria: Prior history of diagnosed TBI. Other significant non-head injury/trauma or open wound. Other significant medical co-morbidities, such as heart disease or cancer. Self-reported current use or substances contributing to ED visit (e.g. illicit drugs, medications, alcohol abuse). Currently diagnosed psychological condition (e.g. depression, PTSD). Medications for psychological or neurological disorder. Any implanted metal, such as medical device or braces on teeth. Injury to the back or other injury that will make it difficult for the participant to tolerate tests. Injury to dominant arm that would cause difficulty using computer or responding to stimuli during functional imaging. Pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mild traumatic brain injury (mTBI)<br>Patients admitted to Huntington Memorial Hospital (HMH), Pasadena CA, Emergency Department (ED) diagnosed with mTBI by history (alteration of consciousness, post-traumatic amnesia, loss of consciousness) and normal brain computed tomography (CT). | |
| Control<br>Patients admitted to HMH ED for minor extremity trauma (sprains) and no evidence of mTBI | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in objective measures of brain function (MEG/EEG, blood biomarkers) | For MEG/EEG, resting state analyses of brain function will be conducted to include frequency band analyses localizing, for example, delta slow wave activity, and establishing functional connectivity scores at three time points post injury (day 1, day 14, day 30). For blood biomarkers, serum levels in approximately ten biomarkers will be measured to determine amount in each and if changes occur at three time points post-injury. | Day 1, day 14, and day 30 post-injury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anatomical measures of brain function (DTI, SWI) | Diffusion Tensor-derived measures will be calculated for control and mTBI participants to determine if changes occur at three time points post-injury (day 1, day 14, day 30). | Day 1, day 14, and day 30 post-injury | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MEG, Mild traumatic injury to extremity (for controls), mTBI, concussion, EEG, Blood, MRI, DTI, biomarkers