Augmentation of Cognitive Training in Children With TBI With D-Cyloserine

NCT02312635 | Unknown Early Phase 1

• 1 other identifier: 1R21HD076418-01A1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

cognitive rehabilitation, traumatic brain injury

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Wide Range Assessment of Memory & Learning-2

  Baseline

• Wide Range Assessment of Memory & Learning-2

  6 weeks

• Wide Range Assessment of Memory & Learning-2

  3 months

Other Outcomes (6)

• Parent Reports

  Baseline

• Parent Reports

  6 weeks

• Parent Reports

  3 months

Study Arms (2)

Cogmed + D-cycloserine

EXPERIMENTAL

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; Behavioral: Cogmed Working Memory Training

Cogmed + Placebo

PLACEBO COMPARATOR

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

Interventions

D-Cycloserine DRUG

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).

Also known as: Drug Trade Name--Seromycin, (D-cycloserine)

Cogmed + D-cycloserine

Cogmed Working Memory Training BEHAVIORAL

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

Cogmed + D-cycloserine; Cogmed + Placebo

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• non-penetrating msTBI (intake or post-resuscitation GCS score between 3 and 12)
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90025, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Cycloserine

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Robert F Asarnow, Ph.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Christopher Giza, M.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Lisa Moran, Ph.D.

  University of California, Los Angeles

  STUDY DIRECTOR

Central Study Contacts

Alma Martinez, M.A.

CONTACT

310-825-0443; aamartinez@mednet.ucla.ed

Robert Asarnow, Ph.D

CONTACT

310-825-0394; rasarnow@mednet.ucla.ed

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Della Martin Professor of Psychiatry, Professor of Psychology

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: December 9, 2014
• Study Start: December 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 9, 2014

Record last verified: 2014-12

Locations

US (1)