CDP-Choline and Working Memory After TBI: A Neuroimaging Study
Condition: Brain Injuries
MeSH terms: Brain Injuries
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Despite the prevalence of working memory deficits following traumatic brain injury (TBI), the
      scientific data regarding pharmacological treatment of this problem is limited. As deficits
      in working memory are known to have a significant impact on functional outcomes for
      individuals with TBI, further research in this area is essential in order for physicians to
      be able to treat this problem more effectively. The primary goal of the proposed project is
      to examine the efficacy of a particular pharmacological agent, CDP-Choline, in the treatment
      of working memory deficits following traumatic brain injury (TBI). The study sample will
      consist of 48 subjects: A group of 24 individuals who have sustained moderate to severe TBI,
      and a group of 24 healthy controls. Each group will be divided into a placebo and treatment
      group. The project will utilize functional Magnetic Resonance Imaging (fMRI) to investigate
      the cerebral neurophysiological effects of treatment with CDP-Choline. A working memory task
      (N-Back) will be employed during fMRI sessions. In addition, the effects of treatment with
      CDP-Choline on neuropsychological testing performance will also be evaluated, and the
      correlations between behavioral performance and neuroimaging results will be observed. We
      will achieve these goals by comparing baseline neuropsychological testing results as well as
      fMRI results, with a second set of testing and neuroimaging results obtained following 1
      month of pharmacological treatment with CDP Choline or placebo. Based on our preliminary
      studies and the available literature, we expect to see the following: Baseline fMRI results
      are expected to show that individuals with TBI display altered patterns of cerebral
      activation during a working memory task, as compared to healthy controls. With CDP-Choline
      treatment, we expect TBI subjects to display fMRI laterality and dispersion patterns that
      more closely resemble patterns of healthy controls. In addition, we anticipate improvements
      in behavioral performance on both the specific working memory task (N-Back), and on
      traditional neuropsychological tests to be associated with CDP-Choline treatment, with
      greater magnitude of change on testing results for the TBI group as compared to any changes
      noted for the control or placebo groups. Finally, we anticipate that specific significant
      correlations will be observed between neuropsychological testing results and neuroimaging
      findings, and that the strength of these relationships will be greater for the TBI treatment
      group, as compared to the placebo or healthy control groups. By conducting the proposed study
      in this manner, we hope to provide scientific data that will allow for improved treatment,
      and ultimately improved functional outcomes for individuals who have sustained TBI.
    

Intervention name(s): CDP-Choline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1000 mg CDP-Choline 2 x per day for 6 weeks.; Treatment with placebo for 6 weeks
Other intervention name(s): Citicoline; Cytidine 5'-diphosphocholine
Intervention MeSH terms: Choline; Cytidine Diphosphate Choline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Traumatic Brain Injury; FMRI; Memory; Cognition; Neuropsychology