Traumatic Brain Injury Clinical Trial
— DCSOfficial title:
Augmentation of Cognitive Training in Children With TBI With D-Cyloserine
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 11 Years to 18 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of California, Los Angeles | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Parent Reports | Parent measures will be administered to assess working memory and attention functioning. | Baseline | No |
Other | Parent Reports | Parent measures will be administered to assess working memory and attention functioning. | 6 weeks | No |
Other | Parent Reports | Parent measures will be administered to assess working memory and attention functioning. | 3 months | No |
Other | Structural & Functional MRI | Structural & Functional Magnetic Resonance Imaging will be completed on participant to get baseline scans before participants begin intervention. | Baseline | No |
Other | Structural & Functional MRI | Structural & Functional Magnetic Resonance Imaging will be completed on participant to get 6 week follow up scans to determine if there were any changes in brain after 6 week drug and working memory task interventions. | 6 weeks | No |
Other | Structural & Functional MRI | Structural & Functional Magnetic Resonance Imaging will be completed on participant to get 6 week follow up scans to determine if there were any changes in brain after 3 months post interventions. | 3 months | No |
Primary | Cogmed Working Memory Training Program | All participants will complete the Cogmed working memory training program for 6 weeks, M-F, for 45 minutes each day. Memory stimuli are presented in a computerized system in a total of 8 visuo-spatial and verbal working memory training exercises. Each training exercise consists of 15 trials. For each of the 8 working memory training exercises difficulty is adjusted by changing the number of stimuli to be remembered. Training is performed close to the capacity of the individual by using an adaptive staircase method that adjusts difficulty on a trial-by-trial basis. At the end of each training day an Improvement Index is calculated that measure improvement during the training period. The Improvement Index is based on the participant's results on 3 exercises. | 6 weeks | No |
Secondary | Wide Range Assessment of Memory & Learning-2 | All participants will be administered this test as a measurement of their working memory at baseline, 6weeks and 3months. | Baseline | No |
Secondary | Wide Range Assessment of Memory & Learning-2 | All participants will be administered this test as a measurement of their working memory at baseline, 6weeks and 3months. | 6 weeks | No |
Secondary | Wide Range Assessment of Memory & Learning-2 | All participants will be administered this test as a measurement of their working memory at baseline, 6weeks and 3months. | 3 months | No |
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