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Clinical Trials/NCT00927576
NCT00927576
Completed
Not Applicable

PC-Based Cognitive Rehabilitation for TBI

US Department of Veterans Affairs0 sites265 target enrollmentJuly 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
US Department of Veterans Affairs
Enrollment
265
Primary Endpoint
Performance in TBI Patients and Controls
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2009
End Date
March 2013
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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:

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

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