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NCT01502839 · ClinicalTrials.gov registry record
Role of NSI in Differentiating Between Mild Traumatic Brain Injury And Behavioral Health Conditions
A clinical trial, sponsored by VA Eastern Colorado Health Care System.
- Terminated
- Registry status
- 887
- Enrollment target
NCT01502839: Clinical Trial study, sponsored by VA Eastern Colorado Health Care System.
NCT01502839 is a clinical trial that was terminated before completion, run by VA Eastern Colorado Health Care System. The registered enrollment target is 887 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01502839 was terminated before completion, sponsored by VA Eastern Colorado Health Care System.
- TERMINATED
- Registry status
- 887 participants
- Enrollment target
Study Summary
The purpose of this study is to examine differences in post-concussive (PC) symptom endorsement among four groups of Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) Veterans: those with a history of target, service-related, mild traumatic brain injury (mTBI) and co-occurring posttraumatic stress disorder (PTSD) (Group 1); those with a history of target, service-related, mTBI only (Group 2); those with PTSD only (Group 3); and those with no history of target, service-related, mTBI or PTSD (Group 4) by examining scores on the Neurobehavioral Symptom Inventory (NSI). Support for this study is provided by previous research highlighting the complex relationship between mTBI, PTSD and subsequent PC symptom endorsement (Brenner et al. 2010; Terrio et al, 2009). HYPOTHESES ARE AS FOLLOWS: 1. Individuals with a history of target, service-related, mTBI only (Group 2) and individuals with PTSD only (Group 3) each will report significantly more PC symptoms, as measured by NSI total scores, when compared to those with no history of service-related mTBI or PTSD (Group 4). 2. Individuals with co-occurring target, service-related, mTBI history and PTSD (Group 1) will report significantly more PC symptoms, as measured by total NSI scores, than either those with target, service-related, mTBI only (Group 2) or those with PTSD only (Group 3).
Primary Outcome
The Neurobehavioral Symptom Inventory (NSI; Cicerone \& Kalmar, 1995)is a 22-item self-report measure of PC symptoms recommended for use among military personnel by the Department of Defense (DoD). Subject responses to all 22 items will be extracted from each subject's TBI Consult Report note provided in her/his Electronic Medical Record (EMR). Estimated time to collect all data from this retrospective chart review is 1 year.
Interventions
- OTHER No Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 887 participants |
| Start Date | 2011-03 |
| Est. Completion | 2015-05 |
Why NCT01502839 stopped before completion
NCT01502839 is an observational study that tracks outcomes without assigning an intervention. The registered 887 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which No Intervention is the first listed.
NCT01502839 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01502839 about?
NCT01502839 is a clinical study titled "Role of NSI in Differentiating Between Mild Traumatic Brain Injury And Behavioral Health Conditions". The purpose of this study is to examine differences in post-concussive (PC) symptom endorsement among four groups of Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) Veterans: those with a history of target, service-related, mild traumatic brain injury (mTBI) and co-occurring posttraum...
What is the current status of trial NCT01502839?
This trial is currently terminated. The enrollment target is 887 participants. The study started on 2011-03. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01502839?
The interventions under investigation include: No Intervention (OTHER).
Who is sponsoring clinical trial NCT01502839?
This trial is sponsored by VA Eastern Colorado Health Care System, which has 42 total clinical trials registered on ClinicalTrials.gov.
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