Traumatic Brain Injury Clinical Trial
Official title:
Utility of Hyperpolarized 13C-Pyruvate Metabolic Magnetic Resonance Imaging in the Diagnosis of Early Cerebral Metabolic Crisis After Traumatic Brain Injury
The purpose of this study is to examine the safety and feasibility of using hyperpolarized metabolic MRI to study early brain metabolism changes in subjects presenting with head injury and suspected non-penetrating traumatic brain injury (TBI). This study will also compare HP pyruvate MRI-derived metrics in TBI patients with healthy subjects as well as Subarachnoid hemorrhage (SAH) patients to better understand if metabolic Magnetic resonance imaging scan (MRI) can improve our ability to diagnose a TBI. The FDA is allowing the use of hyperpolarized [1-13C] pyruvate (HP 13C-pyruvate) in this study. Up to 15 patients (5 with TBI, 5 with SAH, and 5 healthy volunteers) may take part in this study at the University of Maryland, Baltimore (UMB).
Status | Recruiting |
Enrollment | 15 |
Est. completion date | November 26, 2026 |
Est. primary completion date | November 26, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - History of acute head injury with or suspected non-penetrating acute TBI - Suitable to undergo contrast-enhanced MRI - Negative serum pregnancy test Exclusion Criteria: - Inability to undergo MRI scan - Inability to receive IV MRI contrast agents secondary to severe reaction or renal insufficiency - Positive pregnancy test |
Country | Name | City | State |
---|---|---|---|
United States | University of Maryland Baltimore | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
University of Maryland, Baltimore |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measures of conversion of pyruvate to lactate (apparent conversion rate constant kPL, lactate-to-pyruvate ratio) and pyruvate to bicarbonate (apparent conversion rate constant kPB, bicarbonate-to-pyruvate ratio) | To assess the differences between the three patient groups | within two years post enrollment | |
Secondary | Correlation of the conversion of pyruvate to lactate and pyruvate to bicarbonate measures with results from clinical and neuropsychological evaluation. | within two years post enrollment |
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 |