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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02069613

Enrollment

Registered

2014-02-24

Start date

2014-03-31

Completion date

2017-08-01

Last updated

2017-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Concussion, Mild

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in objective measures of brain function (MEG/EEG, blood biomarkers)	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

Measure	Time frame	Description
Change in anatomical measures of brain function (DTI, SWI)	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).

Countries

United States

Outcome results