CDP-Choline and Working Memory After TBI: A Neuroimaging Study
Condition: Brain Injuries
MeSH terms: Brain Injuries
Intervention: CDP-Choline; Placebo
Intervention description: 1000 mg CDP-Choline 2 x per day for 6 weeks.; Treatment with placebo for 6 weeks
Intervention MeSH terms: Choline; Cytidine Diphosphate Choline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Traumatic Brain Injury; FMRI; Memory; Cognition; Neuropsychology

Summary:

      The purpose of this study is to determine whether an investigational drug, called
      "CDP-Choline", improves memory in people with traumatic brain injury (TBI). To do this, we
      are asking for people with traumatic brain injury and people without traumatic brain injury
      to be a part of this study. We will compare results between each group to see if this
      investigational drug makes a difference with memory. We will also compare brain imaging
      results and information collected before and after the taking of the study medication to see
      if there are any differences. We hypothesize that there will be differences in brain
      activation patterns between individuals with TBI and healthy controls, as well as differences
      in performance on memory testing at baseline. We further hypothesize that, after treatment
      with CDP-Choline, the patterns in neuroimaging findings and cognitive testing results for
      individuals with TBI will more closely resemble results observed for healthy individuals. We
      hope that what we learn from this study will be helpful in the future treatment of
      individuals with head injury.
    

Eligibility criteria:

        Inclusion Criteria:

        For individuals with TBI and Health Controls:

          -  right hand dominant

          -  English speaking

          -  No history of neurological illness (for example, stroke, seizure or brain tumor.

          -  No significant history of psychiatric illness (for example, schizophrenia or bipolar
             disorder) or current severe emotional distress.

          -  No visual difficulties that would not allow for reading and following written
             instructions.

          -  Free of alcohol or substance abuse.

          -  Capable of following basic written and oral instructions.

          -  Not taking certain medications that may interact with study medication or interfere
             with neuroimaging.

          -  Be able to take medication in tablet form, or crushed and dissolved in a liquid.

          -  Meet the additional criteria associated with MRI safety standards, as required by the
             University of Pittsburgh Department of Radiology. For example, these criteria include
             exclusion due to surgical placement of metal plates or electronic implants.

        In addition:

        Individuals with TBI must:

          -  Have a specific diagnosis of a moderate to severe traumatic brain injury, which can be
             confirmed through review of medical records or assessments.

          -  Be at least 1 year, but no more than 3 years since injury.

          -  Must have significant working memory problems, as indicated by performance on a
             screening test.

        Normal Control subjects must:

          -  Perform within the normal range on a test of working memory.

        Exclusion Criteria:

          -  Prisoners.

          -  Males with sexual partners who are planning to become pregnant during the treatment
             period.

          -  Females who are currently pregnant or who are planning to become pregnant during the
             treatment period.

          -  Individuals who are currently enrolled in another medication study

          -  Individuals who are currently, or have previously been, treated with CDP-Choline
             (Citicoline) for research or clinical purposes.

          -  Currently in a nursing home in the state of Pennsylvania.