View Clinical Trial (Medical Research Study)
CDP-Choline and Working Memory After TBI: A Neuroimaging Study.
| City: |
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Pittsburgh |
| State: |
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Pennsylvania |
| Zip Code: |
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15213 |
| Conditions: |
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Brain Injuries |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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.
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| NCT ID: |
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NCT00727246 |
| Primary Contact: |
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Principal Investigator
Patricia M. Arenth, Ph.D.
University of Pittsburgh
Patricia M. Arenth, Ph.D.
Phone: 412-648-6186
Email: arenthpm@upmc.edu
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| Backup Contact: |
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Email: harrisonta@upmc.edu
Tina Harrison, MS
Phone: 412-586-6927
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| Location Contact: |
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Pittsburgh, Pennsylvania 15213
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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