Trial Outcomes & Findings for PC-Based Cognitive Rehabilitation for Traumatic Brain Injury (TBI) (NCT NCT00927576)
NCT ID: NCT00927576
Last Updated: 2015-07-31
Results Overview
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.
COMPLETED
265 participants
Subjects were tested in a single 2-hr session.
2015-07-31
Participant Flow
Participant milestones
| Measure |
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.
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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.
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|---|---|---|
|
Overall Study
STARTED
|
237
|
28
|
|
Overall Study
Cognitive Testing
|
237
|
28
|
|
Overall Study
COMPLETED
|
237
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PC-Based Cognitive Rehabilitation for Traumatic Brain Injury (TBI)
Baseline characteristics by cohort
| Measure |
Control Subjects
n=237 Participants
Control subjects = 230. Normal control subjects of various ages.
|
TBI Patients
n=28 Participants
TBI patients N = 30. Mixed mild and severe TBI group, with most showing PTSD comorbidity.
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Total
n=265 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
222 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
250 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Continuous
|
41.0 years
STANDARD_DEVIATION 21.3 • n=5 Participants
|
42.4 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
41.8 years
STANDARD_DEVIATION 14.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
130 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
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Region of Enrollment
United States
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237 participants
n=5 Participants
|
28 participants
n=7 Participants
|
265 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Subjects were tested in a single 2-hr session.Population: Data from two TBI patients were excluded due to suspected suboptimal effort.
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.
Outcome measures
| Measure |
Simple Reaction Time Test
n=263 Participants
time to respond in ms to visual stimuli presented randomly to the left or right hemifield at varying stimulus onset asynchronies.
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|---|---|
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Performance in TBI Patients and Controls
Control group 1, n=189
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237.8 ms
Standard Deviation 27.8
|
|
Performance in TBI Patients and Controls
Control group 2, n =48
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231.5 ms
Standard Deviation 17.72
|
|
Performance in TBI Patients and Controls
Mild TBI, n =22
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228.0 ms
Standard Deviation 34.6
|
|
Performance in TBI Patients and Controls
Severe TBI, n =4
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280.0 ms
Standard Deviation 42.4
|
Adverse Events
Control Subjects
TBI Patients
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place