Recruiting
Early Phase 1

Cognitive Training with D-Cycloserine

Sponsor:

UCLA

Code:

NCT02312635

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 11 - 18

Healthy Volunteers: Not accepted

Interventions

D-Cycloserine

Cogmed Working Memory Training

Study Details

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.

Conditions

Traumatic Brain Injury

Study ID

NCT02312635

Start date

Dec, 2012

Status verified date

Dec, 2014

Completion date

Dec, 2016

Anticipated

Primary completion date

Sep, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 18

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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).

Cogmed Working Memory Training

Both arms of the study will receive Cogmed working memory training for 6 weeks, M-F.

Primary outcome measure

  • Cogmed Working Memory Training Program [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Locations

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90025

Contacts

Principal Investigator:

Robert F Asarnow, Ph.D.

More Information

Sponsor

University of California, Los Angeles

Last update posted

Dec 9, 2014

Last verified

Dec, 2014

Keywords

  • cognitive rehabilitation, traumatic brain injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2014-12-09.