Augmentation of Cognitive Training in Children With TBI With D-Cyloserine
Status:
Unknown status
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
Traumatic Brain Injury (TBI) is the most common cause of death and long-term disability in
children. Much of the long-term disability stems from neurocognitive impairments that are not
greatly helped by current cognitive training and pharmacological treatments for TBI related
cognitive impairments. This study tests the hypothesis that a drug, D-cycloserine (DCS), will
significantly enhance the effect of cognitive training in correcting cognitive impairments in
children with moderate/severe TBIs.
In order to do so, study subjects who fit inclusion criteria, including those with moderate
to severe TBI who show persistent working memory weaknesses based on a screening, will be
recruited. They will have three visits to UCLA. During the first visit, subjects will undergo
an MRI protocol before and after taking a pill (drug or placebo, blinded). They will also
participate in a number of paper and pencil cognitive tests. Then subjects will be enrolled
in a 6 week computerized cognitive training program (CogMed). They will also be prescribed a
drug/placebo pill (depending on which group they are randomized into), which they'll have to
take at regular intervals during the 6 weeks. They will have weekly check in phone calls or
visits by a coach trained in the program to make sure they are following the study protocol
accurately, to have their questions answered, and for motivation. At the end of the training
period, subjects will return to UCLA to again complete the MRI protocol and cognitive
testing. After three months of enrollment, they will have a final visit to UCLA, including
only cognitive testing. A total of 30 subjects will be entered into the study.