Traumatic Brain Injury Clinical Trial
Official title:
Use of a Traumatic Brain Injury (TBI) Screen in a Veteran Mental Health Population: Prevalence, Validation, and Psychiatric Outcomes
The primary aims of this study are to: 1) Establish the concurrent criterion-related validity of four traumatic brain injury (TBI) screening questions (TBI-4) using the Ohio State University TBI Identification Method (OSU TBI-ID) and 2) Establish the concurrent criterion-related validity of the TBI-4 with the addition of detailed information elicited by the four questions. Secondary aims include: 1) Determining if the addition of detailed information elicited by the TBI-4 results in increased specificity; 2) Determining whether the prevalence of traumatic brain injury (TBI) in this sample is concordant with previous research; and 3) Determining whether psychiatric outcomes are worse for veterans with traumatic brain injury (TBI) than those with no traumatic brain injury(TBI).
The primary aims of this study are to: 1) Establish the concurrent criterion-related validity
of four traumatic brain injury (TBI) screening questions (TBI-4) using the Ohio State
University TBI Identification Method (OSU TBI-ID) and 2) Establish the concurrent
criterion-related validity of the TBI-4 with the addition of detailed information elicited by
the four questions. Secondary aims include: 1) Determining if the addition of detailed
information elicited by the TBI-4 results in increased specificity; 2) Determining whether
the prevalence of traumatic brain injury (TBI) in this sample is concordant with previous
research; and 3) Determining whether psychiatric outcomes are worse for veterans with
traumatic brain injury (TBI) than those with no traumatic brain injury(TBI).
Primary Hypotheses:
Hypothesis 1a: The sensitivity and specificity of the TBI-4 will be significantly greater
than 0.75 and 0.80, respectively.
Hypothesis 1b: The sensitivity and specificity of the TBI-4 with the addition of detailed
information elicited by these questions (i.e., free text information entered by the clinician
who administered the TBI-4) will be significantly greater than 0.75 and 0.80, respectively.
Secondary Hypotheses:
Hypothesis 1c: The specificity of the TBI-4 with the addition of detailed information
elicited by these questions (i.e., free text information entered by the clinician who
administered the TBI-4) will be significantly greater than that of the four questions alone.
Hypothesis 2: A significant difference in psychiatric outcomes (psychiatric hospitalizations,
suicidal ideation, suicide attempts and completions, and mental health-related contacts) will
be identified in those with a history of TBI versus those without a history of TBI as
determined, first, by the TBI-4 and, second, by the OSU TBI-ID.
Hypothesis 3: The prevalence of Traumatic Brain Injury- Loss of Consciousness (TBI-LOC) in
this population will be similar to that identified by Walker et al1 (31.7% of individuals
will report 1 or more TBI-LOC).
;
| 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 |