Trial Outcomes & Findings for Quantitative Automated Lesion Detection of Traumatic Brain Injury (NCT NCT01022307)
NCT ID: NCT01022307
Last Updated: 2016-01-14
Results Overview
z-score based on response time, regressed for age and computer use
Recruitment status
COMPLETED
Target enrollment
212 participants
Primary outcome timeframe
Single session generally several years after TBI depending on time of recruitment of subjects.
Results posted on
2016-01-14
Participant Flow
Participant milestones
| Measure |
Group 1: no History of TBI
184 participants with no history of traumatic brain injury (TBI).
|
Group 2: With a History of TBI
28 patients with a history of TBI. Most of these patients had suffered mild TBI.
|
|---|---|---|
|
Overall Study
STARTED
|
184
|
28
|
|
Overall Study
COMPLETED
|
184
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Quantitative Automated Lesion Detection of Traumatic Brain Injury
Baseline characteristics by cohort
| Measure |
Group 1: no History of TBI
n=184 Participants
184 participants with no history of traumatic brain injury (TBI).
|
Group 2: With a History of TBI
n=24 Participants
28 patients with a history of TBI. Most of these patients had suffered mild TBI. 24 underwent multimodal MR imaging.
|
Total
n=208 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
|
|
Age, Categorical
Between 18 and 65 years
|
184 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
40.03 years
STANDARD_DEVIATION 24.2 • n=5 Participants
|
36.16 years
STANDARD_DEVIATION 29.0 • n=7 Participants
|
39.2 years
STANDARD_DEVIATION 25.8 • n=5 Participants
|
|
Gender
Female
|
82 participants
n=5 Participants
|
1 participants
n=7 Participants
|
83 participants
n=5 Participants
|
|
Gender
Male
|
98 participants
n=5 Participants
|
23 participants
n=7 Participants
|
121 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
184 participants
n=5 Participants
|
24 participants
n=7 Participants
|
208 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Single session generally several years after TBI depending on time of recruitment of subjects.Population: z-score
z-score based on response time, regressed for age and computer use
Outcome measures
| Measure |
Group 1: no History of TBI
n=184 Participants
184 participants with no history of traumatic brain injury (TBI).
|
Group 2: With a History of TBI
n=26 Participants
28 patients with a history of TBI. Most of these patients had suffered mild TBI. Two were excluded because of evidence of malingering.
|
|---|---|---|
|
Performance on Trail-making Test, Part B
|
-0.02 z-score
Standard Deviation 0.98
|
0.18 z-score
Standard Deviation 0.95
|
Adverse Events
Group 1: no History of TBI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2: With a History of TBI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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