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Clinical Trials/NCT02069613
NCT02069613
Completed
Not Applicable

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

Huntington Medical Research Institutes3 sites in 1 country44 target enrollmentMarch 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Concussion, Mild
Sponsor
Huntington Medical Research Institutes
Enrollment
44
Locations
3
Primary Endpoint
Change in objective measures of brain function (MEG/EEG, blood biomarkers)
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2014
End Date
August 1, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael G Harrington

Research Scientist

Huntington Medical Research Institutes

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • Change in anatomical measures of brain function (DTI, SWI)(Day 1, day 14, and day 30 post-injury)

Study Sites (3)

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