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Completed

NCT Number: NCT01298557

MEG and DTI of Neural Function and Connectivity in Traumatic Brain Injury

The overall hypothesis is that the long-term cognitive and behavioral sequelae of traumatic brain injury (TBI) are due to selective disruption of the long association white matter tracts of the cerebral hemispheres, with resulting functional impairment of the network of cortical regions that are interconnected by these long-range association pathways. We propose that traumatic white matter injury can be measured with diffusion tensor imaging (DTI) and that the impaired cortical activation can be detected with magnetoencephalography (MEG), and that the results of these imaging examinations will correlate with neurocognitive status and functional recovery after TBI.

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Key information

Conditions

Traumatic Brain Injury Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Post-Concussion Syndrome Post-Concussive Symptoms Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

San Francisco General Hospital

San Francisco, California, 94110, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18-50 years of age
  • single episode of blunt traumatic brain injury
  • symptoms of persistent post-concussive syndrome present an average of 4 months to 4 years since date of injury
  • fluency in English (cognitive battery not available in other languages)
  • capable of self-consent

Exclusion criteria

  • < 18 years or > 50 years of age
  • pregnancy
  • history of previous TBI with loss of consciousness
  • alcoholism as evidenced by Audit questionnaire
  • regular use of illicit drugs
  • non-English fluency
  • significant psychiatric history excluding mild depression or anxiety disorder any contraindication to MRI, including claustrophobia, pregnancy, any trauma or surgery which may have left ferromagnetic material in the body, ferromagnetic implants or pacemakers; and inability to lie still for 1 hour or more

Treatment and study plan

Primary outcomes

  1. Changes in white matter tract structure

    Time frame: up to 4 years following date of injury

    We believe that brain injury results in selective disruption of the associative white matter tracts of the cerebral hemispheres, with resulting functional impairment of the network of cortical regions that are interconnected by these long-range association pathways. We propose that traumatic white matter injury can be measured with diffusion tensor imaging (DTI). We evaluate DTI using 3T and 7T MRI. Participants receive scans at only one time-point.

Secondary outcomes

  1. Neurocognitive function

    Time frame: up to 4 years following date of injury

    We hope to better understand the long-term cognitive and behavioral sequelae of traumatic brain injury (TBI) by correlating neurocognitive testing data with imaging data. We will also compare neurocognitive testing data between patients and controls to help illustrate the impact of brain trauma on these neurocognitive symptoms. Our participants receive testing at only one time-point.

  2. Cortical activation

    Time frame: up to 4 years following date of injury

    We believe that brain injury results in selective disruption of the associative white matter tracts of the cerebral hemispheres, with resulting functional impairment of the network of cortical regions that are interconnected by these long-range association pathways. We propose that impaired cortical activation can be detected with magnetoencephalography (MEG). We will compare patients' data with data of controls. Our participants are scanned at only one time-point.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Magnetoencephalography and High-Field Diffusion Tensor Magnetic Resonance Imaging of Neural Function and Connectivity in Traumatic Brain Injury

Acronym: Dana-REAC

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Feb 17, 2011
Registry last updated
Dec 4, 2018

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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