CClinicalTrials.gg
Sign In
CompletedNCT02069613Updated Nov 8, 2017

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

An observational study in Concussion, Mild, sponsored by Huntington Medical Research Institutes. Completed at 3 sites in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-11-08.

Sponsored by Huntington Medical Research Institutes · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
44
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Concussion, Mild

Keywords

  • Mild traumatic injury to extremity (for controls)
  • mTBI
  • concussion
  • MEG
  • EEG
  • Blood
  • MRI
  • DTI
  • biomarkers
03

In context

Brain Injuries

2,112 studies on the registry are indexed under Brain Injuries; 384 are open to participants now.

This study's enrollment of 44 is below the median of 100 across 689 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Huntington Medical Research Institutes is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
44 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

06

What researchers measure

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.

    Time frame: Day 1, day 14, and day 30 post-injury

Secondary outcomes

  1. 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).

    Time frame: Day 1, day 14, and day 30 post-injury

07

Study locations

3 sites
  • Huntington Medical Research Institutes
    Pasadena, California 91101, United States
  • HMRI
    Pasadena, California 91105, United States
  • Molecular Neurology Program
    Pasadena, California 91105, United States
08

References and documents

Publications

  • 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. PubMed 18234750 ↗
  • 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. PubMed 18078527 ↗
  • 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. PubMed 17510590 ↗
  • 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. PubMed 19385722 ↗
  • 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. PubMed 15580024 ↗
  • 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. PubMed 15111666 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02069613
Lead sponsor
Huntington Medical Research Institutes
Collaborators
U.S. Army Medical Research and Development Command
Responsible party
Michael G Harrington (Research Scientist, Huntington Medical Research Institutes) — Principal investigator
First posted
Feb 24, 2014
Start date
Mar 2014
Primary completion
Aug 1, 2017
Completion
Aug 1, 2017
Last update
Nov 8, 2017

Study contacts

Michael G Harrington, MB
principal investigator · Huntington Medical Research Institutes

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Brain Injuries→

Other studies from this sponsor

Huntington Medical Research Institutes

Start the discussion