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NOT YET RECRUITING
NCT07679126

The Systemic Nature of Severe Traumatic Brain Injury

Sponsor: Corewell Health West

View on ClinicalTrials.gov

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 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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

40

Start Date

2026-12-01

Completion Date

2029-07-01

Last Updated

2026-10-23

Healthy Volunteers

Yes

Locations (1)

Corewell Health West

Grand Rapids, Michigan, United States