Traumatic Brain Injury Clinical Trial
Official title:
Hyperbaric and Normobaric Oxygen in Severe Brain Injury
The purpose of this study is to study the effects of EARLY (no more than 24 four hours from injury) administration of extra amounts of oxygen on traumatic brain injury.
Brain injury continues to be a major cause of death and disability throughout the world. Our
investigations of hyperbaric oxygen treatment (HBOT) indicate that it is a relatively safe
treatment that has promise as a potential therapy for patients with severe traumatic brain
injury (TBI). The goals of the present proposal are to further elucidate the mechanisms of
action of HBOT on severe TBI and to test hypotheses that are crucial to the possible future
design of a Phase III clinical trial.
Our initial prospective clinical trial to assess the effectiveness of HBOT in severe TBI
documented very significant improvement in survival, particularly in certain subgroups of
patients. In our second study, HBOT was found to improve cerebral aerobic metabolism in
patients with severe TBI, reduce elevated intracranial pressure, and had a persistent
positive effect for at least six hours following the treatment. Our work suggests that HBOT
allows the brain to utilize increased amounts of oxygen more efficiently following
treatment.
Recently, increasing the inspired oxygen concentration (FiO2) to 100% has been proposed as
an alternative way of delivering supranormal levels of oxygen to severe TBI patients.
Experimental investigation in the fluid percussion rat model using HBOT at 1.5 ATA
(atmospheres absolute) for 60 minutes followed by 3 hours of 100%fraction of inspired oxygen
(FiO2) have given optimum results in terms of mitochondrial functional and neurobehavioral
improvement.
The clinical and experimental data together provide a strong basis for the restorative
effect of the combination of hyper- and normobaric hyperoxia on severe TBI. The goal of this
study is to evaluate the use of HBOT and 100% FiO2 separately and in combination.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
| 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 |
NCT04199130 -
Cognitive Rehabilitation and Brain Activity of Attention-Control Impairment in TBI
|
N/A | |
| Withdrawn |
NCT05062148 -
Fundamental and Applied Concussion Recovery Modality Research and Development: Applications for the Enhanced Recovery
|
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 |