- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00927576
PC-Based Cognitive Rehabilitation for Traumatic Brain Injury (TBI)
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
Status
Conditions
Intervention / Treatment
- 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
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
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Publications and helpful links
General Publications
- Atkins Whitmer D, Woods DL. Analysis of the cost effectiveness of a suicide barrier on the Golden Gate Bridge. Crisis. 2013;34(2):98-106. doi: 10.1027/0227-5910/a000179.
- Disbrow EA, Russo KA, Higginson CI, Yund EW, Ventura MI, Zhang L, Malhado-Chang N, Woods DL, Sigvardt KA. Efficacy of tailored computer-based neurorehabilitation for improvement of movement initiation in Parkinson's disease. Brain Res. 2012 May 3;1452:151-64. doi: 10.1016/j.brainres.2012.02.073. Epub 2012 Mar 9.
- Whitaker KJ, Kang X, Herron TJ, Woods DL, Robertson LC, Alvarez BD. White matter microstructure throughout the brain correlates with visual imagery in grapheme-color synesthesia. Neuroimage. 2014 Apr 15;90:52-9. doi: 10.1016/j.neuroimage.2013.12.054. Epub 2014 Jan 7.
- Woods DL, Herron TJ, Yund EW, Hink RF, Kishiyama MM, Reed B. Computerized analysis of error patterns in digit span recall. J Clin Exp Neuropsychol. 2011 Aug;33(7):721-34. doi: 10.1080/13803395.2010.550602.
- Hubel KA, Reed B, Yund EW, Herron TJ, Woods DL. Computerized measures of finger tapping: effects of hand dominance, age, and sex. Percept Mot Skills. 2013 Jun;116(3):929-52. doi: 10.2466/25.29.PMS.116.3.929-952.
- Hubel KA, Yund EW, Herron TJ, Woods DL. Computerized measures of finger tapping: reliability, malingering and traumatic brain injury. J Clin Exp Neuropsychol. 2013;35(7):745-58. doi: 10.1080/13803395.2013.824070. Epub 2013 Aug 15.
- Woods DL, Kishiyamaa MM, Lund EW, Herron TJ, Edwards B, Poliva O, Hink RF, Reed B. Improving digit span assessment of short-term verbal memory. J Clin Exp Neuropsychol. 2011 Jan;33(1):101-11. doi: 10.1080/13803395.2010.493149.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B6119-R
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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