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

• Status: Withdrawn
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mclean Hospital
• Treatments: Cytidine Diphosphate Choline

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

• 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.