This investigation will explore the impact of 8 weeks of citicoline treatment on cognitive
function, clinical state and substance use in 40 individuals with mild traumatic brain injury
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01591759
Ages eligible for Study
18 Years to 35 Years
Genders eligible for Study
Accepts Healthy Volunteers
Serious medical illness, including diabetes, neurodegenerative disorder (i.e. multiple sclerosis, lupus, etc)
Neurological disorder or history of serious head trauma resulting in loss of extended loss of consciousness or coma
History of ECT treatment
Estimated IQ < 75
Positive urine pregnancy test (screened on all study visits) Additional MR Imaging
Presence of a medical condition known to affect MR BOLD imaging (i.e. metabolism disorders, eating disorders, hormonal dysregulation, etc)
Uncorrectable poor vision, as subjects must have normal or corrected-to normal vision for viewing of cognitive challenge paradigms during fMRI protocols
Claustrophobia or metal implanted within the body, including body piercings which are not removable
Additional MR related contraindications:
Metal clips on blood vessels (also called stents)
Artificial heart valve, artificial arms, hands, legs, etc.
Brain stimulator devices
Implanted drug pumps
Ear or eye implants
Known metal fragments in eyes
Exposure to metal filings (sheetmetal workers, welders, and others)
Other metallic surgical hardware in vital area
Certain tattoos with metallic ink
Certain transdermal (skin) patches such as:
NicoDerm (nicotine for tobacco dependence)
Transderm Scop (scopolamine for motion sickness)
Ortho Evra (birth control)
Certain intrauterine devices (IUDs containing metal)
Since some will be military veterans with combat experience and may have been exposed to shrapnel, they will be screened with a handheld metal detector to ensure that they do not have any metal embedded in their body. Subjects who do not pass the metal detector screen and subjects with known shrapnel or other metal embedded or implanted in their body will not be eligible to participate in the MRI portion of this study.
All locations for NCT01591759
United States (1)
McLean Hospital Brain Imaging Center
Belmont, Massachusetts, United States, 02478-9106
View full eligibility
Tris trial is registered with FDA with number: NCT01591759. The sponsor of the trial is Mclean Hospital and it is looking for 0 volunteers for the current phase.
Official trial title: A Pilot Trial of Citicoline in Individuals With mTBI
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