Traumatic Brain Injury Clinical Trial
Official title:
Quantitative Automated Lesion Detection of TBI
The investigators propose to develop quantitative automated lesion detection (QALD) procedures to identify brain damage following traumatic brain injury more accurately than is possible with a normal magnetic resonance imaging (MRI) scans. These procedures require about 1 hour of imaging in an MRI scanner. Subjects will also undergo about 2 hours of cognitive tests. The investigators will compare the results of the cognitive tests with those from MRI scanning to determine what brain regions are responsible for superior performance and for performance decrements.
Because of their non-focal nature, TBI-related brain lesions are difficult to detect and
quantify with traditional MRI. In the current research program the investigators propose to
develop quantitative automated lesion detection (QALD) procedures to (1) clarify the nature
and distribution of tissue damage following mild, moderate and severe TBI (2) improve the
capability of detecting, quantifying, and localizing TBI brain damage in individual patients
and (3) correlate quantitative measures of brain damage in individual TBI patients with
neuropsychological deficits in attention, memory, and executive function.
QALD detects abnormal tissue parameters in the diseased brain through statistical
comparisons with a normative database. Preliminary results show that QALD is capable of
detecting highly significant abnormalities in the brains of TBI patients with normal
clinical MRI scans. QALD will be further enhanced and tested with a larger database and
including brain images acquired with four different imaging sequences (T1, T2, DTI and
fluid-attenuated inversion recovery or FLAIR) from 100 control subjects. Data analysis will
incorporate advanced cortical surface mapping techniques to quantify gray matter tissue
parameters and thickness in 34 distinct cortical regions in each hemisphere. In addition,
cortical fiber projections will be quantified with DTI and FLAIR analysis of white matter
lying below the cortical surface. Subcortical fiber tracts critical for complex cognitive
operations will be analyzed with voxel-based morphometry and with improved region of
interest algorithms to define fiber tract boundaries. Tissue properties in critical
subcortical structures (e.g., the hippocampus) will be quantified after automatic
parcellation of these brain regions. The investigators will also test the control subjects
on a battery of neuropsychological tests (NPTs) and correlate variations in the size,
myelination, and tissue properties of normal cortical and subcortical structures with
cognitive performance. Then, the investigators will gather identical imaging data in 99 TBI
patients divided into three groups (mild, moderate and severe TBI) in order to characterize
the average pattern of damage caused by TBIs of different severity. Next, the investigators
will quantify lesions in individual TBI patients and describe the variability of lesion
patterns in the different severity groups. In parallel, the investigators will develop
further multimodal analysis techniques to combine statistical information from different
imaging sequences to improve lesion-detection sensitivity to co-localized abnormalities
evident with different imaging protocols. In addition, the investigators will test patients
with NPTs and analyze the relationship between brain damage, cognitive performance and
self-assessments of outcome in order to improve the prognostic value of neuroradiological
studies of TBI.
;
Observational Model: Case Control, Time Perspective: Retrospective
| 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 |