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

Study Overview
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Brief Summary
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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
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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.

Official Title
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PC-Based Cognitive Rehabilitation for TBI

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 78 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control subjects<br>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. | Behavioral: Digit span testing<br>* Testing of short-term verbal memory with digit span<br>Behavioral: Spatial span testing<br>* Testing of short-term visuospatial memory with spatial span.<br>Behavioral: Finger tapping<br>* Testing motor speed with a finger tapping test.<br>Behavioral: Simple reaction time<br>* Testing the time to respond to the appearance of a visual stimulus.<br>Behavioral: Choice reaction time<br>* Testing the time needed to discriminate and respond to different visual stimuli.<br>Behavioral: Verbal fluency<br>* Evaluating how many words are produced in 90s.<br>Behavioral: Verbal list learning<br>* 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.<br>Behavioral: Trail making test<br>* 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.<br>Behavioral: Design fluency<br>* Subjects create the maximal number of 4-line patterns in 90 s.<br>Behavioral: Questionnaire completion<br>* Question completion time is measured on each question of the Post-Traumatic Stress Disorder check list (PCL) and on the cognitive failures questionnaire.<br>|
| TBI patients<br>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. | Behavioral: Digit span testing<br>* Testing of short-term verbal memory with digit span<br>Behavioral: Spatial span testing<br>* Testing of short-term visuospatial memory with spatial span.<br>Behavioral: Finger tapping<br>* Testing motor speed with a finger tapping test.<br>Behavioral: Simple reaction time<br>* Testing the time to respond to the appearance of a visual stimulus.<br>Behavioral: Choice reaction time<br>* Testing the time needed to discriminate and respond to different visual stimuli.<br>Behavioral: Verbal fluency<br>* Evaluating how many words are produced in 90s.<br>Behavioral: Verbal list learning<br>* 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.<br>Behavioral: Trail making test<br>* 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.<br>Behavioral: Design fluency<br>* Subjects create the maximal number of 4-line patterns in 90 s.<br>Behavioral: Questionnaire completion<br>* Question completion time is measured on each question of the Post-Traumatic Stress Disorder check list (PCL) and on the cognitive failures questionnaire.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance in TBI Patients and Controls | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive training, neuroplasticity, cognitive impairment, recovery of function, memory, attention