Status:
COMPLETED
CDP-Choline and Working Memory After TBI: A Neuroimaging Study
Lead Sponsor:
Patricia M. Arenth
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Brain Injuries
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief 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 ...
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 mem...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00727246
Start Date
March 1 2009
End Date
May 1 2013
Last Update
July 28 2017
Active Locations (1)
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1
University of Pittsburgh, Department of Physical Medicine & Rehabilitation
Pittsburgh, Pennsylvania, United States, 15213