Clinical trial NCT02069613: Multimodal Approach to Testing the Acute Effects of Mild Traumatic Brain Injury (mTBI)
Official title: Multimodal Approach to Testing the Acute Effects of Mild Traumatic Brain Injury (mTBI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Concussion, Mild
Keywords: Mild traumatic injury to extremity (for controls)
mTBI
concussion
MEG
EEG
Blood
MRI
DTI
biomarkers
Lead sponsor: Huntington Medical Research Institutes
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2014-02-24
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Civilian (non-military) presenting to HMH ED.

Exclusion Criteria:

1. Prior history of diagnosed TBI.
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.

Primary outcomes:
measure: Change in objective measures of brain function (MEG/EEG, blood biomarkers)
timeFrame: Day 1, day 14, and day 30 post-injury
Secondary outcomes:
measure: Change in anatomical measures of brain function (DTI, SWI)
timeFrame: Day 1, day 14, and day 30 post-injury
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Huntington Medical Research Institutes
state: California
city: Pasadena
country: United States
facility: HMRI
state: California
city: Pasadena
country: United States
facility: Molecular Neurology Program
state: California
Study officials:
affiliation: Huntington Medical Research Institutes
name: Michael G Harrington, MB
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.