Clinical Trials Directory

Trials / Completed

CompletedNCT00927576

PC-Based Cognitive Rehabilitation for Traumatic Brain Injury (TBI)

PC-Based Cognitive Rehabilitation for TBI

Status
Completed
Phase
Study type
Observational
Enrollment
265 (actual)
Sponsor
US Department of Veterans Affairs · Federal
Sex
All
Age
18 Years – 78 Years
Healthy volunteers
Accepted

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.

Detailed description

Here we describe a series of computer-based tests that were used to evaluate memory, attention, and executive function in large groups of control subjects and in patients with chronic mild and moderate/severe TBI. This extensive battery of neuropsychological tests (NPTs) and subjective rating scale measures were obtained at study entry from the TBI cohort. NPT and rating scale data were compared to those obtained from control subjects to characterize the cognitive deficits following mild, moderate and severe TBI. . Normative data were obtained by regressing the influences of age, education, and computer use on scores to create normed z-scores on different NPTs,. We hypothesized that patient with TBI would show deficits on tests of memory, attention, and executive function relative to their predicted z-scores (based on the aforementioned regression functions) and that deficits would be more pronounced in patients with severe TBI than in patients with mild TBI.

Conditions

Interventions

TypeNameDescription
BEHAVIORALDigit span testingTesting of short-term verbal memory with digit span
BEHAVIORALSpatial span testingTesting of short-term visuospatial memory with spatial span.
BEHAVIORALFinger tappingTesting motor speed with a finger tapping test.
BEHAVIORALSimple reaction timeTesting the time to respond to the appearance of a visual stimulus.
BEHAVIORALChoice reaction timeTesting the time needed to discriminate and respond to different visual stimuli.
BEHAVIORALVerbal fluencyEvaluating how many words are produced in 90s.
BEHAVIORALVerbal list learningEvaluating 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.
BEHAVIORALTrail making testEvaluating 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.
BEHAVIORALDesign fluencySubjects create the maximal number of 4-line patterns in 90 s.
BEHAVIORALQuestionnaire completionQuestion completion time is measured on each question of the Post-Traumatic Stress Disorder check list (PCL) and on the cognitive failures questionnaire.

Timeline

Start date
2009-07-01
Primary completion
2013-03-01
Completion
2013-03-01
First posted
2009-06-25
Last updated
2015-07-31
Results posted
2015-07-31

Source: ClinicalTrials.gov record NCT00927576. Inclusion in this directory is not an endorsement.