Role of NSI in Differentiating Between Mild Traumatic Brain Injury And Behavioral Health Conditions

NCT01502839 | Terminated DMC

• 1 other identifier: 11-0219
• Study Type: observational
• Target: 887
• Locations: 1 country
• Sites: 1

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 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. 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. 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).

Conditions

Traumatic Brain Injury; Post-Concussive Symptoms; Post-Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• Neurobehavioral Symptom Inventory

  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.

  1 day (NSI was administered 1 time during clinical visit and documented in EMR as described below)

Study Arms (1)

OEF/OIF Veterans

Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) Veterans

Other: No Intervention

Interventions

No Intervention OTHER

This retrospective data analysis will rely on data obtained from chart review.

OEF/OIF Veterans

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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 Record (EMR) progress note titles "OEF/OIF TBI 2nd Level Evaluation Consult Report" and "TBI Consult Report" will be used to identify potential subjects.

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• VA Eastern Colorado Health Care System: lead

Study Sites (1)

VA Eastern Colorado Health Care System

Denver, Colorado, 80220, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Post-Concussion Syndrome; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Concussion; Head Injuries, Closed; Wounds, Nonpenetrating; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Gina Signoracci, Ph.D.

  VA Eastern Colorado Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2011
• First Posted: January 2, 2012
• Study Start: March 1, 2011
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 15, 2017

Record last verified: 2012-12

Locations

US (1)