NCT01298557 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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.
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.
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.
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.

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

Clinical trial NCT01298557 - References