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OpenTrials
Completed

NCT Number: NCT02069613

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

HMRI, Pasadena, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Change in objective measures of brain function (MEG/EEG, blood biomarkers)

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

    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.

Secondary outcomes

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

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

    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).

Sponsors and collaborators

Lead sponsor

Huntington Medical Research Institutes

Other

Collaborators

  • U.S. Army Medical Research and Development Command

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Feb 24, 2014
Registry last updated
Nov 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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