Non-invasive Clinical Imaging of Cerebral Metabolism Following Brain Injury Using 13C Magnetic Resonance Spectroscopy.

NCT02745210 | Terminated Results

• 1 other identifier: 59093
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Detection of 13C Enriched Cerebral Metabolites

  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

Study Arms (1)

Experimental

EXPERIMENTAL

13C Magnetic resonance (MR) spectroscopy.

Diagnostic Test: 13C magnetic resonance spectroscopy

Interventions

13C magnetic resonance spectroscopy DIAGNOSTIC_TEST

acquisition of 13C MR spectroscopy in the brain

Also known as: 13C MRS

Experimental

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loma Linda University: lead

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Brenda Bartnik Olson
• Organization: Loma LInda University Medical Center

BBartnik@llu.edu

1-909-558-4000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: April 20, 2016
• Study Start: September 1, 2009
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: December 31, 2020
• Results First Posted: December 31, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share