Clinical trial NCT01298557: MEG and DTI of Neural Function and Connectivity in Traumatic Brain Injury
Official title: Magnetoencephalography and High-Field Diffusion Tensor Magnetic Resonance Imaging of Neural Function and Connectivity in Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Post-concussive Symptoms
Keywords: Traumatic brain injury
Post-concussive symptoms
Brain imaging
Neurocognitive testing
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2011-02-17
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in white matter tract structure
timeFrame: up to 4 years following date of injury
Secondary outcomes:
measure: Neurocognitive function
timeFrame: up to 4 years following date of injury
measure: Cortical activation
timeFrame: up to 4 years following date of injury
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
Study officials:
affiliation: UCSF Department of Radiology and Bioengineering
name: Pratik Mukherjee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.