A Pilot Trial of Citicoline in Individuals With Mild Traumatic Brain Injury (mTBI)

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Traumatic Brain Injury

In brief

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 (mTBI).

Key facts

Study ID

NCT01591759

Run by

Mclean Hospital

People needed

0

Starts

2012-04-01

Expected to finish

2014-04-01

Last updated by the study team

2014-04-23

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is able to provide informed consent
• Subject is cooperative
• Subject is between 18 and 35 years of age (inclusive)
• Subject meets criteria for mTBI
• Subject has separate treating physician and is willing to provide consent for treating physician to be contacted by research team
• Subject is a native English speaker or acquired English prior to age 5

You may not qualify if…

• 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 Exclusion Criteria:
• 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:
• Cardiac pacemakers
• 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)

Where it is running

• McLean Hospital Brain Imaging Center — Belmont, Massachusetts, United States

Full record on ClinicalTrials.gov

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