Status:
UNKNOWN
Augmentation of Cognitive Training in Children With TBI With D-Cyloserine
Lead Sponsor:
University of California, Los Angeles
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
11-18 years
Phase:
EARLY_PHASE1
Brief 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 ...
Detailed Description
Study Design/Procedure: The proposed study uses a double blind, parallel, placebo control design to test the hypotheses that augmentation of suppressed NMDA receptor function following pediatric msTBI...
Eligibility Criteria
Inclusion
- non-penetrating msTBI (intake or post-resuscitation GCS score between 3 and 12)
- 11 to 18 years of age
- between 12 and 24 months post-injury
- working memory index (WMI) standard score below 90 or evidence of at least a 10 point discrepancy between estimated IQ and WMI
- normal visual acuity or vision corrected with contact lenses/eyeglasses
- English skills sufficient to understand instructions and be familiar with common words (the neuropsychological tests used in this study presume competence in English).
Exclusion
- tumor or severe seizures
- motor deficits that prevent the subject from being examined in an MR scanner (e.g. spasms)
- history of psychosis,
- ADHD
- Tourette's Disorder
- learning disability
- mental retardation, autism or substance abuse. The latter conditions are associated with cognitive impairments that might overlap with those caused by TBI.
- participants with any metal implants that prevent them from safely undergoing an MRI scan are excluded.
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02312635
Start Date
December 1 2012
End Date
December 1 2016
Last Update
December 9 2014
Active Locations (1)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90025