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Augmentation of Cognitive Training in Children With TBI With D-Cyloserine (DCS)

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ClinicalTrials.gov Identifier: NCT02312635
Recruitment Status : Unknown
Verified December 2014 by Robert F. Asarnow, Ph.D, University of California, Los Angeles.
Recruitment status was:  Recruiting
First Posted : December 9, 2014
Last Update Posted : December 9, 2014
Sponsor:
Information provided by (Responsible Party):
Robert F. Asarnow, Ph.D, University of California, Los Angeles

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 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.


Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Drug: D-Cycloserine Behavioral: Cogmed Working Memory Training Early Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Augmentation of Cognitive Training in Children With TBI With D-Cyloserine
Study Start Date : December 2012
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Cycloserine

Arm Intervention/treatment
Experimental: Cogmed + D-cycloserine
Partifcipants will receive 6 weeks of cogmed working memory training M-F for 45 min each day. Participants in this arm will also take drug Monday, Wednesday, Friday throughout 6 weeks.
Drug: D-Cycloserine
Half of the participants will be randomly chosen to receive the medication D-cycloserine in addition to the working memory program, while the other group will receive an inactive pill (placebo).
Other Name: Drug Trade Name--Seromycin, (D-cycloserine)

Behavioral: Cogmed Working Memory Training
Both arms of the study will receive Cogmed working memory training for 6 weeks, M-F.

Placebo Comparator: Cogmed + Placebo
Participants will receive 6 weeks of cogmed training M-F and also take a placebo pill Monday, Wednesday, Friday throughout 6 week period.
Behavioral: Cogmed Working Memory Training
Both arms of the study will receive Cogmed working memory training for 6 weeks, M-F.




Primary Outcome Measures :
  1. Cogmed Working Memory Training Program [ Time Frame: 6 weeks ]
    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.


Secondary Outcome Measures :
  1. Wide Range Assessment of Memory & Learning-2 [ Time Frame: Baseline ]
    All participants will be administered this test as a measurement of their working memory at baseline, 6weeks and 3months.

  2. Wide Range Assessment of Memory & Learning-2 [ Time Frame: 6 weeks ]
    All participants will be administered this test as a measurement of their working memory at baseline, 6weeks and 3months.

  3. Wide Range Assessment of Memory & Learning-2 [ Time Frame: 3 months ]
    All participants will be administered this test as a measurement of their working memory at baseline, 6weeks and 3months.


Other Outcome Measures:
  1. Parent Reports [ Time Frame: Baseline ]
    Parent measures will be administered to assess working memory and attention functioning.

  2. Parent Reports [ Time Frame: 6 weeks ]
    Parent measures will be administered to assess working memory and attention functioning.

  3. Parent Reports [ Time Frame: 3 months ]
    Parent measures will be administered to assess working memory and attention functioning.

  4. Structural & Functional MRI [ Time Frame: Baseline ]
    Structural & Functional Magnetic Resonance Imaging will be completed on participant to get baseline scans before participants begin intervention.

  5. Structural & Functional MRI [ Time Frame: 6 weeks ]
    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. Structural & Functional MRI [ Time Frame: 3 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02312635


Contacts
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Contact: Alma Martinez, M.A. 310-825-0443 aamartinez@mednet.ucla.ed
Contact: Robert Asarnow, Ph.D 310-825-0394 rasarnow@mednet.ucla.ed

Locations
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United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90025
Contact: Alma Martinez, M.A.    310-825-0443    aamartinez@mednet.ucla.ed   
Contact: Lisa Moran, Ph.D.       lmoran@mednet.ucla.edu   
Principal Investigator: Robert F Asarnow, Ph.D.         
Principal Investigator: Christopher Giza, M.D.         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Robert F Asarnow, Ph.D. University of California, Los Angeles
Principal Investigator: Christopher Giza, M.D. University of California, Los Angeles
Study Director: Lisa Moran, Ph.D. University of California, Los Angeles

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Responsible Party: Robert F. Asarnow, Ph.D, Della Martin Professor of Psychiatry, Professor of Psychology, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02312635     History of Changes
Other Study ID Numbers: 1R21HD076418-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 9, 2014    Key Record Dates
Last Update Posted: December 9, 2014
Last Verified: December 2014

Keywords provided by Robert F. Asarnow, Ph.D, University of California, Los Angeles:
cognitive rehabilitation, traumatic brain injury

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Cycloserine
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action