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

Completed

• Conditions: Traumatic Brain Injury
• Interventions: Behavioral: Digit span testing; Behavioral: Spatial span testing; Behavioral: Finger tapping; Behavioral: Simple reaction time; Behavioral: Choice reaction time; Behavioral: Verbal fluency; Behavioral: Verbal list learning; Behavioral: Trail making test; Behavioral: Design fluency; Behavioral: Questionnaire completion

• Registration Number: NCT00927576
• Lead Sponsor: US Department of Veterans Affairs

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.

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 Timeline

• Study First Submitted: 2009-06-23
• Study First Submitted QC: 2009-06-24
• Study First Posted: 2009-06-25
• Study Start: 2009-07
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Results First Submitted: 2015-03-05
• Status Verified: 2015-07
• Results First Submitted QC: 2015-07-28
• Last Update Submitted: 2015-07-28
• Results First Posted: 2015-07-31
• Last Update Posted: 2015-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 265

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control subjects	Verbal list learning	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.
Control subjects	Trail making test	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.
TBI patients	Finger tapping	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.
Control subjects	Simple reaction time	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.
TBI patients	Digit span testing	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.
TBI patients	Spatial span testing	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.
TBI patients	Trail making test	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.
Control subjects	Digit span testing	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.
Control subjects	Spatial span testing	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.
Control subjects	Finger tapping	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.
Control subjects	Choice reaction time	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.
TBI patients	Choice reaction time	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.
TBI patients	Simple reaction time	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.
TBI patients	Questionnaire completion	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.
Control subjects	Verbal fluency	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.
Control subjects	Design fluency	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.
Control subjects	Questionnaire completion	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.
TBI patients	Verbal fluency	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.
TBI patients	Design fluency	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.
TBI patients	Verbal list learning	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.

Primary Outcome Measures

Name	Time	Method
Performance in TBI Patients and Controls	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.