Multimodal Approach to Testing the Acute Effects of Mild Traumatic Brain Injury (mTBI)
NCT ID: NCT02069613
Last Updated: 2017-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
44 participants
OBSERVATIONAL
2014-03-31
2017-08-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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).
No interventions assigned to this group
Control
Patients admitted to HMH ED for minor extremity trauma (sprains) and no evidence of mTBI
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Other significant non-head injury/trauma or open wound.
3. Other significant medical co-morbidities, such as heart disease or cancer.
4. Self-reported current use or substances contributing to ED visit (e.g. illicit drugs, medications, alcohol abuse).
5. Currently diagnosed psychological condition (e.g. depression, PTSD).
6. Medications for psychological or neurological disorder.
7. Any implanted metal, such as medical device or braces on teeth.
8. Injury to the back or other injury that will make it difficult for the participant to tolerate tests.
9. Injury to dominant arm that would cause difficulty using computer or responding to stimuli during functional imaging.
10. Pregnancy.
18 Years
50 Years
ALL
No
Sponsors
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U.S. Army Medical Research and Development Command
FED
Huntington Medical Research Institutes
OTHER
Responsible Party
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Michael G Harrington
Research Scientist
Principal Investigators
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Michael G Harrington, MB
Role: PRINCIPAL_INVESTIGATOR
Huntington Medical Research Institutes
Locations
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Huntington Medical Research Institutes
Pasadena, California, United States
HMRI
Pasadena, California, United States
Molecular Neurology Program
Pasadena, California, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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W81XWH-13-1-0005
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
27294/1
Identifier Type: -
Identifier Source: org_study_id