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

US Department of Veterans Affairs (VA) logo

US Department of Veterans Affairs (VA)

Status

Completed

Conditions

Traumatic Brain Injury

Treatments

Behavioral: Trail making test
Behavioral: Spatial span testing
Behavioral: Verbal fluency
Behavioral: Questionnaire completion
Behavioral: Digit span testing
Behavioral: Choice reaction time
Behavioral: Design fluency
Behavioral: Simple reaction time
Behavioral: Finger tapping
Behavioral: Verbal list learning

Study type

Observational

Funder types

Other U.S. Federal agency

Identifiers

NCT00927576
B6119-R

Details and patient eligibility

About

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.

Full 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.

Enrollment

265 patients

Sex

All

Ages

18 to 78 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

265 participants in 2 patient groups

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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