Traumatic Brain Injury Clinical Trial
Official title:
Differentiating Between Mild Traumatic Brain Injury And Behavioral Health Conditions: The Role of The Neurobehavioral Symptom Inventory
Verified date | December 2012 |
Source | VA Eastern Colorado Health Care System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Terminated |
Enrollment | 887 |
Est. completion date | May 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
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: Inclusion Criteria: 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | VA Eastern Colorado Health Care System | Denver | Colorado |
Lead Sponsor | Collaborator |
---|---|
VA Eastern Colorado Health Care System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Recruiting |
NCT05503316 -
The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System
|
N/A | |
Completed |
NCT04356963 -
Adjunct VR Pain Management in Acute Brain Injury
|
N/A | |
Completed |
NCT03418129 -
Neuromodulatory Treatments for Pain Management in TBI
|
N/A | |
Terminated |
NCT03698747 -
Myelin Imaging in Concussed High School Football Players
|
||
Recruiting |
NCT05130658 -
Study to Improve Ambulation in Individuals With TBI Using Virtual Reality -Based Treadmill Training
|
N/A | |
Recruiting |
NCT04560946 -
Personalized, Augmented Cognitive Training (PACT) for Service Members and Veterans With a History of TBI
|
N/A | |
Completed |
NCT05160194 -
Gaining Real-Life Skills Over the Web
|
N/A | |
Recruiting |
NCT02059941 -
Managing Severe Traumatic Brain Injury (TBI) Without Intracranial Pressure Monitoring (ICP) Monitoring Guidelines
|
N/A | |
Recruiting |
NCT03940443 -
Differences in Mortality and Morbidity in Patients Suffering a Time-critical Condition Between GEMS and HEMS
|
||
Recruiting |
NCT03937947 -
Traumatic Brain Injury Associated Radiological DVT Incidence and Significance Study
|
||
Completed |
NCT04465019 -
Exoskeleton Rehabilitation on TBI
|
||
Recruiting |
NCT04530955 -
Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS)
|
N/A | |
Recruiting |
NCT03899532 -
Remote Ischemic Conditioning in Traumatic Brain Injury
|
N/A | |
Suspended |
NCT04244058 -
Changes in Glutamatergic Neurotransmission of Severe TBI Patients
|
Early Phase 1 | |
Completed |
NCT03307070 -
Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumatic Brain Injury
|
N/A | |
Recruiting |
NCT04274777 -
The Relationship Between Lipid Peroxidation Products From Traumatic Brain Injury and Secondary Coagulation Disorders
|
||
Withdrawn |
NCT05062148 -
Fundamental and Applied Concussion Recovery Modality Research and Development: Applications for the Enhanced Recovery
|
N/A | |
Withdrawn |
NCT04199130 -
Cognitive Rehabilitation and Brain Activity of Attention-Control Impairment in TBI
|
N/A | |
Withdrawn |
NCT03626727 -
Evaluation of the Efficacy of Sodium Oxybate (Xyrem®) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia
|
Early Phase 1 |