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

Traumatic Brain Injury Clinical Trial

Official title:

PC-Based Cognitive Rehabilitation for TBI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00927576
• Other study ID #: B6119-R
• Status: Completed
• Phase: N/A
• First received: June 23, 2009
• Last updated: July 28, 2015
• Start date: July 2009
• Est. completion date: March 2013

Study information

• Verified date: July 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 78 Years

Eligibility

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 Design

Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No

External Links

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