Brain Injuries, Traumatic Clinical Trial
Official title:
Exogenous Sodium Lactate Infusion in Traumatic Brain Injury (ELI-TBI)
Metabolic crisis is a state of energy insufficiency due to impaired mitochondrial function as indicated by cerebral microdialysis lactate/pyruvate ratio (LPR). We have performed preliminary mechanistic analysis of alternative fuels in humans and have demonstrated proof of concept that exogenous fuels alter brain metabolism. We will conduct a multicenter, adaptive design-based, proof of concept phase 2 safety study of candidate supplemental fuels in patients with severe traumatic brain injury to determine safety and efficacy.
Metabolic crisis is a state of energy insufficiency due to impaired mitochondrial function as indicated by cerebral microdialysis lactate/pyruvate ratio (LPR). We have performed safety analysis of exogenous sodium lactate infusions in humans and have demonstrated proof of concept that these fuels alter brain metabolism. Animal TBI studies have demonstrated proof of concept for exogenous lactate and pyruvate. We will conduct a multicenter, adaptive design-based, proof of concept biomarker mechanistic safety study of exogenous sodium lactate. The preliminary goal is to determine if exogenous lactate infusion is safe and has a demonstrated effect on selected biomarkers. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04111549 -
GOALS Cognitive Training Delivered to Aging Veterans in Person or Via Telehealth
|
N/A | |
| Recruiting |
NCT05097261 -
Ketamine in Acute Brain Injury Patients.
|
Phase 4 | |
| Completed |
NCT03504709 -
REsting and Stimulus-based Paradigms to Detect Organized NetworkS and Predict Emergence of Consciousness
|
||
| Recruiting |
NCT03899532 -
Remote Ischemic Conditioning in Traumatic Brain Injury
|
N/A | |
| Completed |
NCT05057377 -
Estimating Highest Capacity Performance During Evaluation of Walking for Individuals With Traumatic Brain Injury
|
||
| Completed |
NCT02426749 -
Treatment and Recovery Monitoring of Post TBI Symptoms
|
N/A | |
| Completed |
NCT01339702 -
The EPIC Project: Impact of Implementing the EMS Traumatic Brain Injury Treatment Guidelines
|
||
| Recruiting |
NCT05977270 -
The Effects of Lifebloom One on Physical Activity After Acquired Brain Injury
|
N/A | |
| Recruiting |
NCT04666766 -
Detecting Traumatic Intracranial Hemorrhage With Microwaves and Biomarkers
|
N/A | |
| Active, not recruiting |
NCT04559724 -
Gait Training Through a Novel Over-ground Wearable Robotic System in People With Pyramidal Hemisyndromes
|
N/A | |
| Not yet recruiting |
NCT04515420 -
The Influence of Noradrenaline on Coagulation and Fibrinolysis in Severe Isolated Brain Injury
|
||
| Not yet recruiting |
NCT05569993 -
Glutamine and Traumatic Brain Injury
|
Early Phase 1 | |
| Recruiting |
NCT04331392 -
Online Memory Intervention for Individuals With Traumatic Brain Injury
|
N/A | |
| Completed |
NCT03727737 -
Efficacy of Repetitive Transcranial Magnetic Stimulation for Improvement of Memory in Older Adults With TBI
|
N/A | |
| Completed |
NCT03153397 -
Effect of Prebiotic Fiber- Enriched (scFOS) Enteral Feeding on the Microbiome in Neurological Injury Trauma Patients (PreFEED Microbiome Trial)
|
N/A | |
| Completed |
NCT01336413 -
Neuroactive Steroids and Traumatic Brain Injury (TBI) in OEF/OIF Veterans
|
Phase 2 | |
| Completed |
NCT02004080 -
CREACTIVE - Collaborative REsearch on ACute Traumatic Brain Injury in intensiVe Care Medicine in Europe
|
||
| Completed |
NCT04957563 -
Clinical Utility of Olfactory Rehabilitation: Treatment for Pacients With Neurosensorial Anosmia
|
N/A | |
| Completed |
NCT05179330 -
Visual Feedback in Lower Limb Rehabilitation
|
N/A | |
| Completed |
NCT05397704 -
Brain Oximeter Calibration and Validation Study
|
N/A |