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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00927576
First received: June 23, 2009
Last updated: July 28, 2015
Last verified: July 2015
  Purpose

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.


Condition Intervention
Traumatic Brain Injury
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

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: PC-Based Cognitive Rehabilitation for TBI

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Performance in TBI Patients and Controls [ Time Frame: Subjects were tested in a single 2-hr session. ] [ Designated as safety issue: No ]
    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.


Enrollment: 265
Study Start Date: July 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Behavioral: Digit span testing
Testing of short-term verbal memory with digit span
Behavioral: Spatial span testing
Testing of short-term visuospatial memory with spatial span.
Behavioral: Finger tapping
Testing motor speed with a finger tapping test.
Behavioral: Simple reaction time
Testing the time to respond to the appearance of a visual stimulus.
Behavioral: Choice reaction time
Testing the time needed to discriminate and respond to different visual stimuli.
Behavioral: Verbal fluency
Evaluating how many words are produced in 90s.
Behavioral: 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.
Behavioral: 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.
Behavioral: Design fluency
Subjects create the maximal number of 4-line patterns in 90 s.
Behavioral: 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.
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.
Behavioral: Digit span testing
Testing of short-term verbal memory with digit span
Behavioral: Spatial span testing
Testing of short-term visuospatial memory with spatial span.
Behavioral: Finger tapping
Testing motor speed with a finger tapping test.
Behavioral: Simple reaction time
Testing the time to respond to the appearance of a visual stimulus.
Behavioral: Choice reaction time
Testing the time needed to discriminate and respond to different visual stimuli.
Behavioral: Verbal fluency
Evaluating how many words are produced in 90s.
Behavioral: 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.
Behavioral: 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.
Behavioral: Design fluency
Subjects create the maximal number of 4-line patterns in 90 s.
Behavioral: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Controls subjects of various ages (approximately 230), and TBI patients (approximately 30).

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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927576

Sponsors and Collaborators
Investigators
Principal Investigator: David L. Woods, PhD VA Northern California HCS
  More Information

Additional Information:
Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00927576     History of Changes
Other Study ID Numbers: B6119-R
Study First Received: June 23, 2009
Results First Received: March 5, 2015
Last Updated: July 28, 2015
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
cognitive training
neuroplasticity
cognitive impairment
recovery of function
memory
attention

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on August 27, 2015