Traumatic Brain InjuryNCT02745210
Non-invasive Clinical Imaging of Cerebral Metabolism Following Brain Injury Using 13C Magnetic Resonance Spectroscopy.
A study testing 13C magnetic resonance spectroscopy in people with Traumatic Brain Injury, run by Loma Linda University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- 13C magnetic resonance spectroscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Feb 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the detailed description
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 To combat these effects, new research is needed to identify mechanisms of injury that will lead to potential targets for therapeutic interventions that improve neurological outcome. One promising area of research is the cerebral metabolic dysfunction following TBI. Studies of post-traumatic cerebral metabolism have shown that cerebral metabolic rate of glucose (CMRglc) decreases for a period of days, weeks or months after injury with the duration and degree of hypometabolism correlating to level of consciousness and a strong predictor of long-term neurological outcome. However, specific changes in intermediary carbohydrate metabolic pathways have not yet been identified. In addition, the role of astrocyte metabolism in the post-injury metabolism has not been studied. This study uses in vivo 13C magnetic resonance spectroscopy (MRS) at 3 Tesla, a novel method in the clinical study of TBI, to non-invasively study the metabolic fate and flux of glucose (metabolized in both neurons and astrocytes) and acetate (metabolized in astrocytes) through metabolic pathways during the hypometabolic period.
- Conditions
- Traumatic Brain Injury
- Being tested
- 13C magnetic resonance spectroscopy
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13C magnetic resonance spectroscopyDiagnostic test
Also called 13C MRS
acquisition of 13C MR spectroscopy in the brain
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 13C Magnetic resonance (MR) spectroscopy. Receives: Diagnostic Test: 13C magnetic resonance spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startSep 2009
- Primary completionFeb 2019
- Study completionFeb 2019
Why it stopped: The acquisition sequence was incompatible with MRI hardware
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brenda Bartnik Olson, PhD, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745210
- Sponsor's protocol ID
- 59093
- Status last verified
- Dec 2020
- First submitted
- 18 Apr 2016
- Last updated
- 31 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Clinical Imaging of Cerebral Metabolism Following Brain Injury Using 13C Magnetic Resonance Spectroscopy
- ClinicalTrials.gov ID
- NCT02745210
- Acronym / sponsor ID
- 59093
- Conditions
- Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The acquisition sequence was incompatible with MRI hardware
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Sep 2009 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Posted 31 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 To combat these effects, new research is needed to identify mechanisms of injury that will lead to potential targets for therapeutic interventions that improve neurological outcome. One promising area of research is the cerebral metabolic dysfunction following TBI. Studies of post-traumatic cerebral metabolism have shown that cerebral metabolic rate of glucose (CMRglc) decreases for a period of days, weeks or months after injury with the duration and degree of hypometabolism correlating to level of consciousness and a strong predictor of long-term neurological outcome. However, specific changes in intermediary carbohydrate metabolic pathways have not yet been identified. In addition, the role of astrocyte metabolism in the post-injury metabolism has not been studied. This study uses in vivo 13C magnetic resonance spectroscopy (MRS) at 3 Tesla, a novel method in the clinical study of TBI, to non-invasively study the metabolic fate and flux of glucose (metabolized in both neurons and astrocytes) and acetate (metabolized in astrocytes) through metabolic pathways during the hypometabolic period.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Diagnostic Test: 13C magnetic resonance spectroscopy13C Magnetic resonance (MR) spectroscopy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 13C magnetic resonance spectroscopyAlso: 13C MRSacquisition of 13C MR spectroscopy in the brain | Diagnostic test | Experimental |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 13C magnetic resonance spectroscopy in people with Traumatic Brain Injury, run by Loma Linda University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of 13C Enriched Cerebral Metabolites (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2020.