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

Traumatic Brain Injury Clinical Trial

— Dana-REAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01298557
• Other study ID #: Dana-REAC
• Status: Completed
• Start date: February 2007
• Est. completion date: February 2013

Study information

• Verified date: November 2018
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Post-Concussion Syndrome
• Post-concussive Symptoms
• Traumatic Brain Injury
• Wounds and Injuries

Locations

Country	Name	City	State
United States	San Francisco General Hospital	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. Review. — View 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. Epub 2004 Jun 8. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 4 years following date of injury
Secondary	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.	up to 4 years following date of injury
Secondary	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.	up to 4 years following date of injury