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

July 28, 2015 updated by: US Department of Veterans Affairs

PC-Based Cognitive Rehabilitation for 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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

265

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Testing of short-term verbal memory with digit span
Testing of short-term visuospatial memory with spatial span.
Testing motor speed with a finger tapping test.
Testing the time to respond to the appearance of a visual stimulus.
Testing the time needed to discriminate and respond to different visual stimuli.
Evaluating how many words are produced in 90s.
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.
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.
Subjects create the maximal number of 4-line patterns in 90 s.
Question completion time is measured on each question of the Post-Traumatic Stress Disorder check list (PCL) and on the cognitive failures questionnaire.
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.
Testing of short-term verbal memory with digit span
Testing of short-term visuospatial memory with spatial span.
Testing motor speed with a finger tapping test.
Testing the time to respond to the appearance of a visual stimulus.
Testing the time needed to discriminate and respond to different visual stimuli.
Evaluating how many words are produced in 90s.
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.
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.
Subjects create the maximal number of 4-line patterns in 90 s.
Question completion time is measured on each question of the Post-Traumatic Stress Disorder check list (PCL) and on the cognitive failures questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Subjects were tested in a single 2-hr session.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

June 23, 2009

First Submitted That Met QC Criteria

June 24, 2009

First Posted (Estimate)

June 25, 2009

Study Record Updates

Last Update Posted (Estimate)

July 31, 2015

Last Update Submitted That Met QC Criteria

July 28, 2015

Last Verified

July 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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