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

An observational study of Traumatic Brain Injury, run by US Department of Veterans Affairs.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 to 78 yearsHealthy volunteers can take part
Conditions the study is for: Traumatic Brain Injury
What is being tested?: Digit span testing, Spatial span testing and Finger tapping
Type of treatment: Lifestyle or therapy programme
How many people: 265 participants
Where: No sites listed yet
Study dates: Jul 2009to Mar 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 78 years
All sexes
Healthy volunteers accepted
Adult, Older adult

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

Who may be able to join

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

Who cannot join

History of TBI
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.
current substance abuse
current psychiatric diagnosis other than PTSD

About this study

Official title: PC-Based Cognitive Rehabilitation for TBI

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.

Read the 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.

Conditions: Traumatic Brain Injury
Being tested: Digit span testing, Spatial span testing, Finger tapping, Simple reaction time, Choice reaction time
Keywords: cognitive training, neuroplasticity, cognitive impairment, recovery of function, memory, attention
Medical subject headings: Brain Injuries, Traumatic, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00927576
Study group	Role	What they receive
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. Receives: 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
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. Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Subjects were tested in a single 2-hr session.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2009Mar 2013

First posted25 Jun 2009 (estimated)
Study startJul 2009
Primary completionMar 2013
Study completionMar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Ecologic or community
Time perspective: Cross-sectional
Enrolment: 265 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00927576
Sponsor's protocol ID: B6119-R
Status last verified: Jul 2015
First submitted: 23 Jun 2009
Last updated: 31 Jul 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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.
PubMed 23261913
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.
PubMed 22459048
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.
PubMed 24406309
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.
PubMed 21957866
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.
PubMed 24175464
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.
PubMed 23947782
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.
PubMed 20680884

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma

All Traumatic Brain Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PC-Based Cognitive Rehabilitation for TBI
ClinicalTrials.gov ID: NCT00927576
Acronym / sponsor ID: B6119-R
Conditions: Traumatic Brain Injury
Keywords: cognitive training, neuroplasticity, cognitive impairment, recovery of function, memory, attention
Study type: Observational
Recruitment status: Completed
Enrolment: 265 participants (actual)
Lead sponsor: US Department of Veterans AffairsUS federal agency
Study start: Jul 2009
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 25 Jun 2009 (estimated)
Results: Posted 31 Jul 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Ecologic or community
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
Control subjects	–	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 completionControl 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.
TBI patients	–	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 completionTBI 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.

Who may qualify

Ages: 18 to 78 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Controls subjects of various ages (approximately 230), and TBI patients (approximately 30).

Key inclusion criteria (7 listed)

(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

Key exclusion criteria (4 listed)

History of TBI
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Digit span testingTesting of short-term verbal memory with digit span	Behavioural	Control subjects, TBI patients
Spatial span testingTesting of short-term visuospatial memory with spatial span.	Behavioural	Control subjects, TBI patients
Finger tappingTesting motor speed with a finger tapping test.	Behavioural	Control subjects, TBI patients
Simple reaction timeTesting the time to respond to the appearance of a visual stimulus.	Behavioural	Control subjects, TBI patients
Choice reaction timeTesting the time needed to discriminate and respond to different visual stimuli.	Behavioural	Control subjects, TBI patients
Verbal fluencyEvaluating how many words are produced in 90s.	Behavioural	Control subjects, TBI patients
Verbal list learningEvaluating 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.	Behavioural	Control subjects, TBI patients
Trail making testEvaluating 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.	Behavioural	Control subjects, TBI patients
Design fluencySubjects create the maximal number of 4-line patterns in 90 s.	Behavioural	Control subjects, TBI patients
Questionnaire completionQuestion completion time is measured on each question of the Post-Traumatic Stress Disorder check list (PCL) and on the cognitive failures questionnaire.	Behavioural	Control subjects, TBI patients

Primary outcome

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.

Results and safety

Results posted to the registry on 31 Jul 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Subjects	237	237
TBI Patients	28	28

Primary outcome: Performance in TBI Patients and Controls

Time frame: Subjects were tested in a single 2-hr session.. Mean (Standard Deviation). Unit: ms

Measure	Simple Reaction Time Test n = 263
Control group 1, n=189	237.8 (27.8)
Control group 2, n =48	231.5 (17.72)
Mild TBI, n =22	228.0 (34.6)
Severe TBI, n =4	280.0 (42.4)

Simple Reaction Time Test: Difference in z-score, sTBI vs. controls: 2.04, p < 0.001, ANOVA
Simple Reaction Time Test: z-score difference between groups: -0.30, p = .50, ANOVA

Population analysed: Data from two TBI patients were excluded due to suspected suboptimal effort.

Adverse events

Time frame: Entire study duration (4 years).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Subjects	0 of 237 (0%)	0 of 237 (0%)	Not reported
TBI Patients	0 of 28 (0%)	0 of 28 (0%)	Not reported

Limitations and caveats (from the sponsor): Relatively small TBI group limits strength of conclusions. Not all of the results have yet been fully analyzed and subjected to peer-review.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23261913Atkins 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.
Background: PubMed 22459048Disbrow 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.
Background: PubMed 24406309Whitaker 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.
Results publication: PubMed 21957866Woods 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.
Results publication: PubMed 24175464Hubel 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.
Results publication: PubMed 23947782Hubel 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.
Results publication: PubMed 20680884Woods 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.

Related trials for Traumatic Brain Injury

Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David L. Woods, PhD principal investigator

VA Northern California HCS

Questions about this trial

What is this clinical trial studying?

An observational study of Traumatic Brain Injury, run by US Department of Veterans Affairs.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performance in TBI Patients and Controls (time frame: Subjects were tested in a single 2-hr session.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00927576, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2015.