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CompletedNCT01298557Dana-REACUpdated Dec 4, 2018

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

An observational study in Traumatic Brain Injury and Post-concussive Symptoms, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-04.

Sponsored by University of California, San Francisco · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
69
Ages
18 Years to 50 Years
Sex
All
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Study summary

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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Conditions studied

  • Traumatic Brain Injury
  • Post-concussive Symptoms

Keywords

  • Traumatic brain injury
  • Post-concussive symptoms
  • Brain imaging
  • Neurocognitive testing
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In context

Brain Injuries

2,112 studies on the registry are indexed under Brain Injuries; 384 are open to participants now.

This study's enrollment of 69 is below the median of 100 across 689 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Participants will be recruited through the neurosurgery clinic at San Francisco General Hospital or referred to us by colleagues.

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

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
69 participants (actual)
Patient registry
No

Groups and cohorts

  • Traumatic brain injured patients

    This group consists of participants who suffered a traumatic brain injury an average of 4 months to 4 years prior to testing. Patients must not have history of prior head injury, substance abuse, psychiatric illness, or contraindications to MRI.

  • Controls (no traumatic brain injury)

    This group consists of participants who do not have a history of brain trauma. Furthermore, controls must not suffer from substance abuse, psychiatric illness, or have contraindications to the MRI.

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What researchers measure

Primary outcomes

  1. Changes in white matter tract structure

    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.

    Time frame: up to 4 years following date of injury

Secondary outcomes

  1. Neurocognitive function

    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.

    Time frame: up to 4 years following date of injury

  2. Cortical activation

    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.

    Time frame: up to 4 years following date of injury

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Study locations

1 site
  • San Francisco General Hospital
    San Francisco, California 94110, United States
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References and documents

Publications

  • Arfanakis K, Haughton VM, Carew JD, Rogers BP, Dempsey RJ, Meyerand ME. Diffusion tensor MR imaging in diffuse axonal injury. AJNR Am J Neuroradiol. 2002 May;23(5):794-802. PubMed 12006280 ↗
  • Deipolyi AR, Mukherjee P, Gill K, Henry RG, Partridge SC, Veeraraghavan S, Jin H, Lu Y, Miller SP, Ferriero DM, Vigneron DB, Barkovich AJ. Comparing microstructural and macrostructural development of the cerebral cortex in premature newborns: diffusion tensor imaging versus cortical gyration. Neuroimage. 2005 Sep;27(3):579-86. doi: 10.1016/j.neuroimage.2005.04.027. PubMed 15921934 ↗
  • Hillebrand A, Singh KD, Holliday IE, Furlong PL, Barnes GR. A new approach to neuroimaging with magnetoencephalography. Hum Brain Mapp. 2005 Jun;25(2):199-211. doi: 10.1002/hbm.20102. PubMed 15846771 ↗
  • Hughes DG, Jackson A, Mason DL, Berry E, Hollis S, Yates DW. Abnormalities on magnetic resonance imaging seen acutely following mild traumatic brain injury: correlation with neuropsychological tests and delayed recovery. Neuroradiology. 2004 Jul;46(7):550-8. doi: 10.1007/s00234-004-1227-x. Epub 2004 Jun 8. PubMed 15185054 ↗
  • Huisman TA, Sorensen AG, Hergan K, Gonzalez RG, Schaefer PW. Diffusion-weighted imaging for the evaluation of diffuse axonal injury in closed head injury. J Comput Assist Tomogr. 2003 Jan-Feb;27(1):5-11. doi: 10.1097/00004728-200301000-00002. PubMed 12544235 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01298557
Lead sponsor
University of California, San Francisco
Responsible party
Sponsor
First posted
Feb 17, 2011
Start date
Feb 2007
Primary completion
Feb 2013
Completion
Feb 2013
Last update
Dec 4, 2018

Study contacts

Pratik Mukherjee, MD, PhD
principal investigator · UCSF Department of Radiology and Bioengineering

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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