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Cogmed + D-cycloserine for Traumatic Brain Injury (DCS Trial)

Phase < 1
Waitlist Available
Led By Robert F Asarnow, Ph.D.
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

DCS Trial 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.

Eligible Conditions
  • Traumatic Brain Injury

DCS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cogmed Working Memory Training Program
Secondary outcome measures
Wide Range Assessment of Memory & Learning-2
Other outcome measures
Parent Reports
Structural & Functional MRI

DCS Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cogmed + D-cycloserineExperimental Treatment2 Interventions
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.
Group II: Cogmed + PlaceboPlacebo Group1 Intervention
Participants will receive 6 weeks of cogmed training M-F and also take a placebo pill Monday, Wednesday, Friday throughout 6 week period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cogmed Working Memory Training
2017
N/A
~170
Cycloserine
FDA approved

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,533 Previous Clinical Trials
10,265,552 Total Patients Enrolled
Robert F Asarnow, Ph.D.Principal InvestigatorUniversity of California, Los Angeles
Christopher Giza, M.D.Principal InvestigatorUniversity of California, Los Angeles

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~2 spots leftby May 2025