- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01298557
MEG and DTI of Neural Function and Connectivity in Traumatic Brain Injury (Dana-REAC)
November 30, 2018 updated by: University of California, San Francisco
Magnetoencephalography and High-Field Diffusion Tensor Magnetic Resonance Imaging 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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
69
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Francisco, California, United States, 94110
- San Francisco General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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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 is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in white matter tract structure
Time Frame: up to 4 years following date of injury
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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.
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up to 4 years following date of injury
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurocognitive function
Time Frame: up to 4 years following date of injury
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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.
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up to 4 years following date of injury
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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.
|
up to 4 years following date of injury
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Pratik Mukherjee, MD, PhD, UCSF Department of Radiology and Bioengineering
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Primary Completion (ACTUAL)
February 1, 2013
Study Completion (ACTUAL)
February 1, 2013
Study Registration Dates
First Submitted
February 9, 2011
First Submitted That Met QC Criteria
February 16, 2011
First Posted (ESTIMATE)
February 17, 2011
Study Record Updates
Last Update Posted (ACTUAL)
December 4, 2018
Last Update Submitted That Met QC Criteria
November 30, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dana-REAC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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