- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02745210
Non-invasive Clinical Imaging of Cerebral Metabolism Following Brain Injury Using 13C Magnetic Resonance Spectroscopy.
Non-invasive Clinical Imaging of Cerebral Metabolism Following Brain Injury Using 13C Magnetic Resonance Spectroscopy
Despite the decline in fatal traumatic brain injury (TBI) incidence in recent years, TBI morbidity remains a public health challenge and is the leading cause of disability in the United States. Detailed knowledge of the metabolic alterations following TBI will provide a significant advancement to our understanding of the hypometabolic response to TBI, which is key information for the future development and testing of novel therapeutic interventions that by-pass or compensate for the metabolic dysfunction.
The goal of this study is to determine the clinical utility of in vivo 13C MRS to identify specific metabolic alterations following TBI. We hypothesize that following TBI, metabolic pathways are altered causing an incomplete oxidative of glucose in neurons and astrocytes resulting in a decrease in cerebral metabolism.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects will be at least 18 years of age without gender or ethnic restrictions.
- Severe accidental TBI defined as the lowest post-resuscitation GCS < 8 prior to administration of sedatives or paralytics.
- Eligibility for MRI per routine screening checklist.
Exclusion Criteria:
- History of neurosurgical intervention, excluding the placement of ventriculostomy shunt
- History of a prior known brain injury with associated loss of consciousness.
- History of a known neurological disorder prior to qualifying injury.
- History of psychiatric disorder.
- History of diabetes or current unstable serum glucose level.
- Renal insufficiency or known history of kidney disease.
- Known contraindication to MRI such as, pacemaker, pregnancy, and/or other non-MR compatible implanted device.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
13C Magnetic resonance (MR) spectroscopy.
|
acquisition of 13C MR spectroscopy in the brain
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detection of 13C Enriched Cerebral Metabolites
Time Frame: 5 years
|
Direct detection, localized in vivo 13C MRS will be used to measure the 13C enrichment of glutamate and glutamine following an infusion of 30% isotopically enriched [1-13C] glucose and [1, 2-13C2] acetate.
|
5 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 59093
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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