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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-13-1-0005 | Other Grant/Funding Number | USAMRMC |
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| Name | Class |
|---|---|
| U.S. Army Medical Research and Development Command | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild traumatic brain injury (mTBI) | 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 | Patients admitted to HMH ED for minor extremity trauma (sprains) and no evidence of mTBI |
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| 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 |
| 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 |
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Inclusion Criteria:
1. Civilian (non-military) presenting to HMH ED.
Exclusion Criteria:
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Study participants (control, mTBI) will be referred by the Huntington Hospital Emergency Department staff. ED staff will determine the eligibility criteria. If consent is achieved, testing will occur at pre-determined times: 1 day, 14 days, and 30 days post-injury.
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| Name | Affiliation | Role |
|---|---|---|
| Michael G Harrington, MB | Huntington Medical Research Institutes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntington Medical Research Institutes | Pasadena | California | 91101 | United States | ||
| HMRI |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18234750 | Background | Hoge CW, McGurk D, Thomas JL, Cox AL, Engel CC, Castro CA. Mild traumatic brain injury in U.S. Soldiers returning from Iraq. N Engl J Med. 2008 Jan 31;358(5):453-63. doi: 10.1056/NEJMoa072972. Epub 2008 Jan 30. | |
| 18078527 | Background | Bigler ED. Neuropsychology and clinical neuroscience of persistent post-concussive syndrome. J Int Neuropsychol Soc. 2008 Jan;14(1):1-22. doi: 10.1017/S135561770808017X. |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Blood will be retained for future analysis.
| Pasadena |
| California |
| 91105 |
| United States |
| Molecular Neurology Program | Pasadena | California | 91105 | United States |
| 17510590 | Background | Lewine JD, Davis JT, Bigler ED, Thoma R, Hill D, Funke M, Sloan JH, Hall S, Orrison WW. Objective documentation of traumatic brain injury subsequent to mild head trauma: multimodal brain imaging with MEG, SPECT, and MRI. J Head Trauma Rehabil. 2007 May-Jun;22(3):141-55. doi: 10.1097/01.HTR.0000271115.29954.27. |
| 19385722 | Background | Huang MX, Theilmann RJ, Robb A, Angeles A, Nichols S, Drake A, D'Andrea J, Levy M, Holland M, Song T, Ge S, Hwang E, Yoo K, Cui L, Baker DG, Trauner D, Coimbra R, Lee RR. Integrated imaging approach with MEG and DTI to detect mild traumatic brain injury in military and civilian patients. J Neurotrauma. 2009 Aug;26(8):1213-26. doi: 10.1089/neu.2008.0672. |
| 15580024 | Background | Pelinka LE, Kroepfl A, Schmidhammer R, Krenn M, Buchinger W, Redl H, Raabe A. Glial fibrillary acidic protein in serum after traumatic brain injury and multiple trauma. J Trauma. 2004 Nov;57(5):1006-12. doi: 10.1097/01.ta.0000108998.48026.c3. |
| 15111666 | Background | Vos PE, Lamers KJ, Hendriks JC, van Haaren M, Beems T, Zimmerman C, van Geel W, de Reus H, Biert J, Verbeek MM. Glial and neuronal proteins in serum predict outcome after severe traumatic brain injury. Neurology. 2004 Apr 27;62(8):1303-10. doi: 10.1212/01.wnl.0000120550.00643.dc. |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |