NCT00927576

Brief Summary

The investigators evaluated whether it was possible to improve the measurement of memory, attention, and executive function in patients who have suffered traumatic brain injury through the use of computer-based testing. Note: the original design of the study was altered due to failure to recruit sufficient numbers of patients who were willing to undergo prolonged cognitive training.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2009

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2009

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

July 31, 2015

Completed
Last Updated

July 31, 2015

Status Verified

July 1, 2015

Enrollment Period

3.7 years

First QC Date

June 23, 2009

Results QC Date

March 5, 2015

Last Update Submit

July 28, 2015

Conditions

Traumatic Brain Injury

Keywords

cognitive trainingneuroplasticitycognitive impairmentrecovery of functionmemoryattention

Outcome Measures

Primary Outcomes (1)

  • Performance in TBI Patients and Controls

    Subjects were assessed on a set of cognitive tests. Here we describe the results on the simple reaction time test in which subjects respond as rapidly as possible to the computer-controlled occurrence of a visual stimulus by pressing a mouse button. Two control groups were used. One large control group underwent a single test to provide data from subjects with a broad range of age and education. The other, smaller, control group underwent three tests at weekly intervals to evaluate the test-retest reliability of the measure.

    Subjects were tested in a single 2-hr session.

Study Arms (2)

Control subjects

Control subjects = 237. These subjects underwent extensive testing with computerized neuropsychological tests including digit span testing, spatial span testing, simple reaction time testing, choice reaction time testing, finger tapping, verbal fluency, design fluency, verbal list learning, questionnaire completion, and the trail making test.

Behavioral: Digit span testingBehavioral: Spatial span testingBehavioral: Finger tappingBehavioral: Simple reaction timeBehavioral: Choice reaction timeBehavioral: Verbal fluencyBehavioral: Verbal list learningBehavioral: Trail making testBehavioral: Design fluencyBehavioral: Questionnaire completion

TBI patients

TBI patients N = 28. These patients underwent extensive testing with computerized neuropsychological tests including digit span testing, spatial span testing, simple reaction time testing, choice reaction time testing, finger tapping, verbal fluency, design fluency, verbal list learning, questionnaire completion, and the trail making test.

Behavioral: Digit span testingBehavioral: Spatial span testingBehavioral: Finger tappingBehavioral: Simple reaction timeBehavioral: Choice reaction timeBehavioral: Verbal fluencyBehavioral: Verbal list learningBehavioral: Trail making testBehavioral: Design fluencyBehavioral: Questionnaire completion

Interventions

Digit span testingBEHAVIORAL

Testing of short-term verbal memory with digit span

Control subjectsTBI patients
Spatial span testingBEHAVIORAL

Testing of short-term visuospatial memory with spatial span.

Control subjectsTBI patients
Finger tappingBEHAVIORAL

Testing motor speed with a finger tapping test.

Control subjectsTBI patients
Simple reaction timeBEHAVIORAL

Testing the time to respond to the appearance of a visual stimulus.

Control subjectsTBI patients
Choice reaction timeBEHAVIORAL

Testing the time needed to discriminate and respond to different visual stimuli.

Control subjectsTBI patients
Verbal fluencyBEHAVIORAL

Evaluating how many words are produced in 90s.

Control subjectsTBI patients
Verbal list learningBEHAVIORAL

Evaluating short-term memory, learning, and memory interference in the recall of 12-word lists, presented three times. Evaluating long-term memory and recognition after a 20 min interval.

Control subjectsTBI patients
Trail making testBEHAVIORAL

Evaluating visuomotor speed and executive function in Trail Making Tests, A and B. In the first, subjects connect successive numbers with the mouse. In the second, they connect numbers and letters in alternation.

Control subjectsTBI patients
Design fluencyBEHAVIORAL

Subjects create the maximal number of 4-line patterns in 90 s.

Control subjectsTBI patients
Questionnaire completionBEHAVIORAL

Question completion time is measured on each question of the Post-Traumatic Stress Disorder check list (PCL) and on the cognitive failures questionnaire.

Control subjectsTBI patients

Eligibility Criteria

Age18 Years - 78 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Controls subjects of various ages (approximately 230), and TBI patients (approximately 30).

You may qualify if:

  • (a) fluency in the English language
  • (b) no current or prior history of bipolar disorder, mania, or schizophrenia
  • (c) no current substance abuse
  • (d) no concurrent history of neurologic disease known to affect cognitive functioning
  • (e) on a stable dosage of any required medication
  • (f) auditory functioning sufficient to understanding normal conversational speech and visual acuity normal or corrected to 20/40 or better

You may not qualify if:

  • History of TBI
  • current substance abuse
  • current psychiatric diagnosis other than PTSD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Atkins Whitmer D, Woods DL. Analysis of the cost effectiveness of a suicide barrier on the Golden Gate Bridge. Crisis. 2013;34(2):98-106. doi: 10.1027/0227-5910/a000179.

    PMID: 23261913BACKGROUND

  • Disbrow EA, Russo KA, Higginson CI, Yund EW, Ventura MI, Zhang L, Malhado-Chang N, Woods DL, Sigvardt KA. Efficacy of tailored computer-based neurorehabilitation for improvement of movement initiation in Parkinson's disease. Brain Res. 2012 May 3;1452:151-64. doi: 10.1016/j.brainres.2012.02.073. Epub 2012 Mar 9.

    PMID: 22459048BACKGROUND

  • Whitaker KJ, Kang X, Herron TJ, Woods DL, Robertson LC, Alvarez BD. White matter microstructure throughout the brain correlates with visual imagery in grapheme-color synesthesia. Neuroimage. 2014 Apr 15;90:52-9. doi: 10.1016/j.neuroimage.2013.12.054. Epub 2014 Jan 7.

    PMID: 24406309BACKGROUND

  • Woods DL, Herron TJ, Yund EW, Hink RF, Kishiyama MM, Reed B. Computerized analysis of error patterns in digit span recall. J Clin Exp Neuropsychol. 2011 Aug;33(7):721-34. doi: 10.1080/13803395.2010.550602.

    PMID: 21957866RESULT

  • Hubel KA, Reed B, Yund EW, Herron TJ, Woods DL. Computerized measures of finger tapping: effects of hand dominance, age, and sex. Percept Mot Skills. 2013 Jun;116(3):929-52. doi: 10.2466/25.29.PMS.116.3.929-952.

    PMID: 24175464RESULT

  • Hubel KA, Yund EW, Herron TJ, Woods DL. Computerized measures of finger tapping: reliability, malingering and traumatic brain injury. J Clin Exp Neuropsychol. 2013;35(7):745-58. doi: 10.1080/13803395.2013.824070. Epub 2013 Aug 15.

    PMID: 23947782RESULT

  • Woods DL, Kishiyamaa MM, Lund EW, Herron TJ, Edwards B, Poliva O, Hink RF, Reed B. Improving digit span assessment of short-term verbal memory. J Clin Exp Neuropsychol. 2011 Jan;33(1):101-11. doi: 10.1080/13803395.2010.493149.

    PMID: 20680884RESULT

MeSH Terms

Conditions

Brain Injuries, TraumaticCognitive Dysfunction

Interventions

Trail Making Test

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Limitations and Caveats

Relatively small TBI group limits strength of conclusions. Not all of the results have yet been fully analyzed and subjected to peer-review.

Results Point of Contact

Title
Dr. David L. Woods
Organization
VANCHCS
dlwoods@ucdavis.edu
925-372-2571

Study Officials

  • David L. Woods, PhD

    VA Northern California HCS

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2009

First Posted

June 25, 2009

Study Start

July 1, 2009

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

July 31, 2015

Results First Posted

July 31, 2015

Record last verified: 2015-07