Status:
TERMINATED
Role of NSI in Differentiating Between Mild Traumatic Brain Injury And Behavioral Health Conditions
Lead Sponsor:
VA Eastern Colorado Health Care System
Conditions:
Traumatic Brain Injury
Post-Concussive Symptoms
Eligibility:
All Genders
18-60 years
Brief 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...
Detailed Description
Archival data will be collected from all OEF/OIF Veterans who were seen in the VA ECHCS TBI Clinic by Nancy Cutter, M.D. and her team between January 1, 2009 and December 31, 2010. Electronic Medical ...
Eligibility Criteria
Inclusion
- Inclusion criteria for all groups includes:
- Veteran must be between the ages of 18 to 60
- Veteran must have at least one OEF/OIF deployment
- Veteran must have received an OEF/OIF TBI 2nd Level Evaluation though the VA ECHCS TBI Clinic
- Specific inclusion/exclusion criteria for each group are as follows:
- Group 1: (Both) Co-Occurring PTSD and target, service-related, mTBI
- PTSD:
- Clinician confirmed PTSD diagnosis and continuous documentation of symptoms related to PTSD diagnosis within 1 year prior to being seen in the TBI Clinic, or
- Clinician confirmed PTSD diagnosis within 1 year prior to being seen in the TBI Clinic, or
- Clinician confirmed PTSD diagnosis within 60 days after being seen in TBI Clinic
- Target, service-related, mTBI
- Veterans with clinician confirmed target, service-related, mTBI per OEF/OIF TBI 2nd Level Evaluation Consult Report note in EMR
- Group 2: (mTBI only) History of target, service-related, mTBI but with no diagnosis of PTSD
- PTSD:
- Veterans with no history of clinician confirmed PTSD diagnosis, or
- Veterans with previous clinician confirmed PTSD diagnosis , but without continuous documentation of PTSD symptoms within 1 year prior to being seen in the TBI clinic
- Target, service-related, mTBI
- Veterans with clinician confirmed target, service-related, mTBI per OEF/OIF TBI 2nd Level Evaluation Consult Report note in EMR
- Group 3: (PTSD only) No history of target, service-related, mTBI but with a diagnosis of PTSD
- PTSD:
- Clinician confirmed PTSD diagnosis and continuous documentation of symptoms related to PTSD diagnosis within 1 year prior to being seen in the TBI Clinic, or
- Clinician confirmed PTSD diagnosis within 1 year prior to being seen in the TBI Clinic, or
- Clinician confirmed PTSD diagnosis within 60 days of being seen in TBI Clinic
- TBI:
- Veterans with no history of clinician confirmed diagnosis of target, service-related, mTBI
- Veterans with clinician confirmed mTBI prior to service and without continuous documentation of related symptoms within 1 year of being seen in the TBI Clinic
- Group 4: (Neither) No history of target, service-related, mTBI and no diagnosis of PTSD
- PTSD:
- Veterans with no history of clinician confirmed PTSD diagnosis, or
- Veterans with previous clinician confirmed PTSD diagnosis , but without continuous documentation of PTSD symptoms within 1 year of being seen in the TBI clinic
- TBI:
- Veterans with no clinician confirmed diagnosis of target, service-related, mTBI
Exclusion
- Those not meeting inclusion criteria as listed above, and
- Veterans with any history of clinician confirmed moderate or severe TBI, and
- Veterans with no NSI in TBI Consult Report note in EMR
- Veterans with documentation of any neurological event or disorder other than mTBI
- Veterans with positive brain imaging
Key Trial Info
Start Date :
March 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
887 Patients enrolled
Trial Details
Trial ID
NCT01502839
Start Date
March 1 2011
End Date
May 1 2015
Last Update
May 15 2017
Active Locations (1)
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1
VA Eastern Colorado Health Care System
Denver, Colorado, United States, 80220