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

Completed

• Conditions: Concussion, Mild

• Registration Number: NCT02069613
• Lead Sponsor: Huntington Medical Research Institutes

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.

Study Timeline

• Study First Submitted: 2014-02-18
• Study First Submitted QC: 2014-02-20
• Study First Posted: 2014-02-24
• Study Start: 2014-03
• Primary Completion: 2017-08-01
• Study Completion: 2017-08-01
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-06
• Last Update Posted: 2017-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (3)

Huntington Medical Research Institutes; 🇺🇸 Pasadena, California, United States

HMRI; 🇺🇸 Pasadena, California, United States

Molecular Neurology Program; 🇺🇸 Pasadena, California, United States