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

NCT02069613 | Completed

• 2 other identifiers: 27294/1W81XWH-13-1-0005
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 3

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.

Conditions

Concussion, Mild

Keywords

Mild traumatic injury to extremity (for controls); mTBI; concussion; MEG; EEG; Blood; MRI; DTI; biomarkers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in anatomical measures of brain function (DTI, SWI)

  Day 1, day 14, and day 30 post-injury

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• \. Civilian (non-military) presenting to HMH ED.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huntington Medical Research Institutes: lead
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (3)

Huntington Medical Research Institutes

Pasadena, California, 91101, United States

Location

HMRI

Pasadena, California, 91105, United States

Location

Molecular Neurology Program

Pasadena, California, 91105, United States

Location

Related Publications (6)

• 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.

  PMID: 18234750 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.

  PMID: 18078527 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.

  PMID: 17510590 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.

  PMID: 19385722 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.

  PMID: 15580024 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.

  PMID: 15111666 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood will be retained for future analysis.

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Michael G Harrington, MB

  Huntington Medical Research Institutes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: February 24, 2014
• Study Start: March 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: November 8, 2017

Record last verified: 2017-11

Locations

US (3)