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

Concussion, Mild Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02069613
• Other study ID #: 27294/1
• Secondary ID: W81XWH-13-1-0005
• Status: Completed
• Phase: N/A
• First received: February 18, 2014
• Last updated: November 6, 2017
• Start date: March 2014
• Est. completion date: August 1, 2017

Study information

• Verified date: November 2017
• Source: Huntington Medical Research Institutes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Concussion, Mild

Locations

Country	Name	City	State
United States	HMRI	Pasadena	California
United States	Huntington Medical Research Institutes	Pasadena	California
United States	Molecular Neurology Program	Pasadena	California

Sponsors (2)

Lead Sponsor	Collaborator
Huntington Medical Research Institutes	U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States, 

References & Publications (6)

Bigler ED. Neuropsychology and clinical neuroscience of persistent post-concussive syndrome. J Int Neuropsychol Soc. 2008 Jan;14(1):1-22. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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