The Systemic Nature of Severe Traumatic Brain Injury

NCT07679126 | Not Yet Recruiting

• 1 other identifier: 2026-1285
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Severe Traumatic brain injury (sTBI) is a very serious problem, and right now, doctors don't have special treatments to help stop additional injury. Previous studies showed that when a young person gets this kind of brain injury, their body's defense system reacts quickly and strongly. This can cause problems with the brain's protective barrier breaking down and the body making antibodies that attack its own cells. We think that changes in how the brain and the gut (the part of your body that digests food) talk to each other might make these defense reactions stronger. This study wants to figure out exactly how brain injuries change the gut and how that affects the body's defenses. To do this, we will use new ways to study body chemicals and genes \[RNA, cell free DNA (cfDNA) and blood chemistry\] to help us learn why the body reacts this way and how it can lead to more brain injuries and problems in adults with serious brain injuries.

Conditions

Severe Traumatic Brain Injury

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  1 year

Study Arms (2)

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).

Eligibility Criteria

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

Study Population

Patients diagnosed with sTBI as defined as a Glascow Coma Scale (GCS) of 8 or less

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corewell Health West: lead
• Corewell Health East: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be collected for the RNA-seq analysis. Urine, stool, and saliva will be collected for future biomarker testing.

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

Study Officials

• Elizabeth A Steensma, MD, FACS

  Corewell Health West

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Franklyn

CONTACT

6163914051; Ashley.Franklyn@corewellhealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 1, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: July 1, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share