Severe Traumatic Brain InjuryMANTRANCT07679126
The Systemic Nature of Severe Traumatic Brain Injury
An observational study of Severe Traumatic Brain Injury, run by Corewell Health West at 1 site in United States.
Trial summary
Severe traumatic brain injury (sTBI) is a devastating condition with no targeted therapies available to prevent secondary injury. Previous studies have demonstrated that brain injury in adolescents initiates an acute and robust immune response characterized by disruption of the blood-brain barrier and the formation of… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Severe Traumatic Brain Injury
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 1 Jul 2029
- Phase
- Observational
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
Study population: Patients diagnosed with sTBI as defined as a Glascow Coma Scale (GCS) of 8 or less
Who may be able to join
- All patients must be between the ages of 18 to 65 at time of enrollment
- Study group cohort will consist of at least 20 patients admitted with severe TBI, defined as a GSC less than or equal to 8 with evidence of intracranial pathology on imaging.
- Trauma control cohort will include at least 10 patients matched on demographics and injury patterns without traumatic brain injury.
- Healthy control cohort will be comprised of 10 patients without acute traumatic injury or illness, matched to the sTBI patients based on demographics and medical comorbidities.
Who cannot join
- Pregnant Patients
- Prisoners
- Patients less than 18 years of age or greater than 65 years of age
- Patients with a penetrating brain injury mechanism, known neurodegenerative or psychiatric disorders, prior known traumatic brain injury, intracranial neoplasm, patients receiving massing transfusion or blood products prior to arrival, terminal illness or not expected to survive, confirmed or suspected brain death, known autoimmune or immunological condition, receiving immunosuppressant or immunomodulatory therapies, having a cardiac event leading to the injury, or for whom consent is unable to be obtained.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Corewell Health West
Grand Rapids, Michigan, 49503
Kendra Selby, 616-486-0281, kendra.selby@helendevoschildrens.org
Ashley Franklin, Ashley.Franklin@corewellhealth.org
About this study
Official title: The Systemic Nature of Severe Traumatic Brain Injury: Multi-Omic Analysis of Neural Trauma, Autoantibodies and the Gut-Brain Axis: The MANTRA Study
Severe traumatic brain injury (sTBI) is a devastating condition with no targeted therapies available to prevent secondary injury. Previous studies have demonstrated that brain injury in adolescents initiates an acute and robust immune response characterized by disruption of the blood-brain barrier and the formation of autoantibodies.
Alterations in the gut-brain axis may contribute to increased immune activation and autoantibody formation following sTBI. The primary objective of this study is to better understand the immune mechanisms involved in the interaction between brain injury and changes in gut permeability through the gut-brain axis.
To investigate these mechanisms, the study will use a multi-platform metabolomics approach in combination with ribonucleic acid (RNA) sequencing, cell-free deoxyribonucleic acid (cfDNA) analysis, and blood chemistry. These analyses will be used to evaluate early immune activation and the mechanisms associated with secondary and tertiary brain injury and neurodegeneration in adults with sTBI.
Read the detailed description
Detailed Description
Severe traumatic brain injury (sTBI) is a devastating condition for which no targeted therapies currently exist. Current acute management strategies are largely focused on stabilizing cerebral physiology rather than addressing the molecular mechanisms responsible for injury progression.
The initial traumatic injury and subsequent secondary injury processes, including neuroinflammation, neurotoxicity, and disruption of the blood-brain barrier (BBB), may contribute to a robust autoimmune response. Pilot studies in adolescents have demonstrated activation of a strong immune response characterized by BBB disruption and autoantibody formation. This response may contribute to short- and long-term inflammatory sequelae, including exacerbation of the initial injury, progression to chronic neurodegenerative disease, increased disability, and mortality.
Alterations in the gut-brain axis may serve as a potential source of increased immunogenicity and subsequent autoantibody formation. The primary objective of this project is to define the immune mechanisms involved in the interaction between brain injury and alterations in gut permeability through the gut-brain axis.
Metabolomics comprehensively profiles and quantifies small-molecule metabolites produced by cells, tissues, and microorganisms, allowing for the evaluation of metabolic pathways and their roles in specific biological processes. Although several omics studies have characterized time-dependent changes in adults and experimental models, comparable studies using multi-omics approaches in sTBI remain limited. This represents an important gap in understanding the biological mechanisms involved in injury progression.
Lipids are essential to cellular function because of their roles in membrane composition, cellular signaling, and energy metabolism, particularly within the brain. Lipidomics, a subfield of metabolomics, identifies and quantifies lipids across cell types, organs, and organisms. Investigation of cellular lipid pathways and networks may provide important insight into the molecular mechanisms underlying traumatic brain injury (TBI). Emerging lipidomic studies suggest that circulating and central nervous system (CNS)-derived lipid signatures are associated with injury severity, BBB disruption, and long-term neurodegenerative risk. Therefore, lipidomics may provide important information for the comprehensive evaluation of sTBI pathogenesis.
The gut-brain axis is a bidirectional communication network between the gastrointestinal tract and CNS. It has been implicated in the pathophysiology of several neurodegenerative disorders and, more recently, in TBI. Following sTBI, rapid alterations may occur in gastrointestinal motility, epithelial barrier integrity, immune signaling, and microbial community structure. Collectively, these changes may result in gut dysbiosis and increased intestinal permeability, potentially due to diffuse mucosal barrier dysfunction.
Maintenance of gastrointestinal mucosal integrity requires coordinated interactions between the epithelial lining, associated cellular junctions, and immune mechanisms that regulate permeability and absorption. In contrast, the BBB is highly regulated and relatively impermeable under normal physiological conditions. Following brain injury, BBB permeability may increase, allowing the entry of molecules that would not typically cross the barrier. These peripheral disturbances may contribute to neuroinflammation, oxidative stress, and neurodegeneration. However, the precise mechanisms underlying these interactions remain unclear and are a primary focus of this study.
To identify the cells and molecular pathways involved in these alterations, single-cell RNA sequencing (scRNA-seq) will be combined with global metabolomics, with particular emphasis on identifying unique gut-derived metabolites, including bacterial products and food antigens that are not typically detected in serum. Single-cell RNA sequencing will be used to identify circulating cell types and clonal activation. These findings will be integrated with metabolomic data to further characterize the mechanisms through which increased gut permeability may contribute to neurotoxicity following sTBI.
This multi-omics approach is intended to develop a comprehensive model of the cellular and molecular mechanisms involved in the interaction between the gut and brain following sTBI. Ultimately, these findings may identify potential therapeutic targets aimed at reducing immune activation and attenuating secondary and tertiary brain injury.
- Conditions
- Severe Traumatic Brain Injury
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | The first cohort (Study Group) will consist of at least 20 patients admitted to CH Butterworth Hospital with a severe TBI, defined as a GCS ≤ 8 with evidence of intracranial pathology on imaging. | |
| Trauma Control | The second cohort (Trauma Control) will include at least 10 patients matched on demographics and injury patterns without traumatic brain injury (head AIS 0). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic immune and metabolic responses after sTBI
Characterize the circulating cellular transcriptome using Bulk RNA-seq and single-cell RNA sequencing ScRNA-seq, compared to trauma and healthy controls to identify circulating cell types, clonal activity, and antibody formation that contribute to injury progression.
Measured: Time of injury and 1-month
Identifying the mechanisms of immune activation driving secondary injury
Define barrier disruption by performing both the 1H NMR and LC-MS metabolomic analysis (global, targeted, and lipidomics), transcriptomics, and proteomics to measure gut and blood-brain barrier permeability and markers of inflammation and neurodegeneration. Pinpoint cell types, pathways, and antibody-mediated mechanisms contributing to progressive brain injury by integrating transcriptomic and metabolomic datasets.
Measured: 1 year
Establishment of a biorepository for future biomarker discovery and data integration with the sTBI patient registry for long-term follow-up.
Bank stool and oral flora samples to study gut dysbiosis and investigate the link between gut microbiome and TBI and longitudinal downstream metabolic consequences leading neurodegeneration and psychiatric pathologies· Bank bronchoalveolar lavage (when available), and plasma for additional future ScRNA analyses at defined timepoints. Establish longitudinal outcomes by leveraging a newly developed sTBI registry to follow patients over time, linking early immune and barrier changes with long-term risk of neurodegeneration.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Traumatic Brain InjuryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corewell Health West
- Sponsor type
- University, hospital or other
- Collaborators
- Corewell Health East
- Responsible party
- Principal investigator, Alistair Chapman, Corewell Health West
- Investigators
- Elizabeth A Steensma, MD, FACS, Principal investigator, Corewell Health West
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679126
- Sponsor's protocol ID
- 2026-1285
- Acronym
- MANTRA
- Status last verified
- Oct 2026
- First submitted
- 25 Jun 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No