Trial Outcomes & Findings for Top-Down Executive Control in Traumatic Brain Injury (TBI), PTSD and Combined (NCT NCT01072006)
NCT ID: NCT01072006
Last Updated: 2017-09-12
Results Overview
Functional magnetic resonance imaging (fMRI) is used to measure neural activity in participants during attentional task, specifically measured as a bold signal change from rest to attention task. We then calculate the correlation between the bold signal (fMRI) and the PTSD CheckList questionnaire score. (The bold signal from fMRI indirectly reflects the brain's use of glucose, the brain's main energy source.) Correlations are reflected in an R-value, and R-values can range from 0-1, where 0 means there is no correlation (or relationship) between the two measures (here, the two measures are the fMRI brain signal and the PTSD score) and 1 means there is a perfect correlation between the two measures. A high correlation in this study would suggest that the more severe a patient's PTSD symptoms are, the harder their brain is having to work to accomplish the attention task. Separate correlations were analyzed for each group, and the overall R-value for each group is reported below.
COMPLETED
30 participants
These are chronic patients and controls who will only be tested at one time point, which corresponds to their entry into the study (after signing consent forms). Data collected at this single time point will be reported.
2017-09-12
Participant Flow
VANCHCS clinic recruitment 2011-2015
This was not a clinical trial so there was no random assignment to groups. Rather, patients fell into distinct groups based on their clinical history (e.g., history of TBI or PTSD or both or neither).
Participant milestones
| Measure |
Control Group
Control group without traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD)
|
PTSD Group
PTSD (not TBI)
|
TBI Group
TBI (no PTSD)
|
TBI+PTSD Group
Combined TBI history and PTSD
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
5
|
0
|
11
|
|
Overall Study
COMPLETED
|
14
|
5
|
0
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Top-Down Executive Control in Traumatic Brain Injury (TBI), PTSD and Combined
Baseline characteristics by cohort
| Measure |
Control Group
n=14 Participants
Control group without traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD)
|
PTSD Group
n=5 Participants
PTSD (not TBI)
|
TBI Group
TBI (no PTSD)
|
TBI+PTSD Group
n=11 Participants
Combined TBI history and PTSD
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
30.8 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
33.8 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
—
|
28.8 years
STANDARD_DEVIATION 4.3 • n=4 Participants
|
30.6 years
STANDARD_DEVIATION 4.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
5 participants
n=7 Participants
|
—
|
11 participants
n=4 Participants
|
30 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: These are chronic patients and controls who will only be tested at one time point, which corresponds to their entry into the study (after signing consent forms). Data collected at this single time point will be reported.Functional magnetic resonance imaging (fMRI) is used to measure neural activity in participants during attentional task, specifically measured as a bold signal change from rest to attention task. We then calculate the correlation between the bold signal (fMRI) and the PTSD CheckList questionnaire score. (The bold signal from fMRI indirectly reflects the brain's use of glucose, the brain's main energy source.) Correlations are reflected in an R-value, and R-values can range from 0-1, where 0 means there is no correlation (or relationship) between the two measures (here, the two measures are the fMRI brain signal and the PTSD score) and 1 means there is a perfect correlation between the two measures. A high correlation in this study would suggest that the more severe a patient's PTSD symptoms are, the harder their brain is having to work to accomplish the attention task. Separate correlations were analyzed for each group, and the overall R-value for each group is reported below.
Outcome measures
| Measure |
Control Group
n=14 Participants
Control group without traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD)
|
PTSD Group
n=5 Participants
PTSD (not TBI)
|
TBI+PTSD Group
n=11 Participants
Combined TBI history and PTSD
|
TBI+PTSD Group
Combined TBI history and PTSD
|
|---|---|---|---|---|
|
Functional Magnetic Resonance Imaging (fMRI) Correlation
|
.21 r-value
|
.19 r-value
|
.36 r-value
|
—
|
SECONDARY outcome
Timeframe: These are chronic patients and controls who will only be tested at one time point, which corresponds to their entry into the study (after signing consent forms). Data collected at this single time point will be reported.The PCL is a 17-item questionnaire that measures PTSD symptoms on a scale that ranges from 17-85 points. The total severity score is reported below. A higher score means a higher level of PTSD symptoms.
Outcome measures
| Measure |
Control Group
n=14 Participants
Control group without traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD)
|
PTSD Group
n=5 Participants
PTSD (not TBI)
|
TBI+PTSD Group
Combined TBI history and PTSD
|
TBI+PTSD Group
n=11 Participants
Combined TBI history and PTSD
|
|---|---|---|---|---|
|
Psychodiagnostic Testing: Post-traumatic Stress Disorder Check List (PCL) Measures the Level of Post-traumatic Stress Disorder (PTSD) Symptoms
|
27.2 units on a scale
Standard Deviation 9.4
|
56.6 units on a scale
Standard Deviation 11.2
|
—
|
60.4 units on a scale
Standard Deviation 12.3
|
SECONDARY outcome
Timeframe: These are chronic patients and controls who will only be tested at one time point, which corresponds to their entry into the study (after signing consent forms). Data collected at this single time point will be reported.This test provides an estimate of pre-morbid IQ, which is important to report so that the patient sample can be compared to other similar studies for comparable IQ level and so that pre-morbid IQ can be considered as a potential variable. There are 50 items that are each given a score of 1, so the range of scores is 0-50. The raw score is then converted into an estimated IQ score based on age and education. The scores reported below reflect this estimated IQ score, where normal IQ scores range from 75 as low average to 125 as high average.
Outcome measures
| Measure |
Control Group
n=14 Participants
Control group without traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD)
|
PTSD Group
n=5 Participants
PTSD (not TBI)
|
TBI+PTSD Group
Combined TBI history and PTSD
|
TBI+PTSD Group
n=11 Participants
Combined TBI history and PTSD
|
|---|---|---|---|---|
|
Neuropsychological Testing (Wechsler Test of Adult Reading)
|
103.3 units on a scale
Standard Deviation 5.7
|
95.2 units on a scale
Standard Deviation 7.9
|
—
|
102.1 units on a scale
Standard Deviation 8.9
|
Adverse Events
Control Group
PTSD Group
TBI Group
TBI+PTSD Group
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