N/A
N=212
Quantitative Automated Lesion Detection of Traumatic Brain Injury
Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT01022307 ↗Enrolled (actual)
212
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcome: Primary: Performance on Trail-making Test, Part B — -0.02; 0.18 z-score — p=< 0.04
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Performance on Trail-making Test, Part B |
-0.02; 0.18 | < 0.04 sig |
Summary
The investigators propose to develop quantitative automated lesion detection (QALD) procedures to identify brain damage following traumatic brain injury more accurately than is possible with a normal magnetic resonance imaging (MRI) scans. These procedures require about 1 hour of imaging in an MRI scanner. Subjects will also undergo about 2 hours of cognitive tests. The investigators will compare the results of the cognitive tests with those from MRI scanning to determine what brain regions are responsible for superior performance and for performance decrements.
Eligibility Criteria
Inclusion Criteria
- Control subjects from 18-50.
- Patients from 18-50 who have suffered TBI.
Exclusion Criteria
- Substance abuse.
- Irremedial sensory deficits (blindness, deafness).
- Primary psychiatric disorder.
- Neurological disease unrelated to TBI.
Data sourced from ClinicalTrials.gov (NCT01022307). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.