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

H

Huntington Medical Research Institutes

Status

Completed

Conditions

Concussion, Mild

Study type

Observational

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT02069613
W81XWH-13-1-0005 (Other Grant/Funding Number)
27294/1

Details and patient eligibility

About

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.

Full 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.

Enrollment

44 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No 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.

Trial design

44 participants in 2 patient groups

Mild traumatic brain injury (mTBI)
Description:
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
Description:
Patients admitted to HMH ED for minor extremity trauma (sprains) and no evidence of mTBI

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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