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Completed

NCT Number: NCT00927576

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Control subjects were required to meet the following inclusion criteria:

  • (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

Exclusion criteria

  • History of TBI

Exclusion criteria

for TBI patients:

  • TBI patients had to meet the same inclusion criteria as the controls with the exception that they were required to have a history of TBI. They also had to be in the chronic phase, i.e., 1-4 yrs post-injury.
  • Exclusion criteria:
  • current substance abuse
  • current psychiatric diagnosis other than PTSD

Treatment and study plan

Digit span testing

Behavioral

Testing of short-term verbal memory with digit span

Spatial span testing

Behavioral

Testing of short-term visuospatial memory with spatial span.

Finger tapping

Behavioral

Testing motor speed with a finger tapping test.

Simple reaction time

Behavioral

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

Choice reaction time

Behavioral

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

Verbal fluency

Behavioral

Evaluating how many words are produced in 90s.

Verbal list learning

Behavioral

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.

Trail making test

Behavioral

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.

Design fluency

Behavioral

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

Questionnaire completion

Behavioral

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

Primary outcomes

  1. Performance in TBI Patients and Controls

    Time frame: Subjects were tested in a single 2-hr session.

    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.

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Official study title

PC-Based Cognitive Rehabilitation for TBI

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jun 25, 2009
Registry last updated
Jul 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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