NCT03908541

Peripheral Inflammation and Brain Structural Alterations in Patients With Disorders of Consciousness.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 14 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Evidence suggests that inflammatory processes are key elements in the secondary effects of severe traumatic brain injury (TBI). The present study was designed to examine whether the peripheral inflammatory markers and brain structural alterations be associated with clinical measures and primary outcome following severe TBI. We hypothesized that peripheral inflammatory markers might be correlated with voxel-based GM volumes in patients with disorder of consciousness.

Detailed description

Background: Systemic inflammation, neurocognitive impairments, and morphologic brain changes are associated with outcome in patients with disorder of consciousness. Objective: The aim of this study is to assess the value of peripheral inflammatory markers and brain structural alterations in the chronic phase after severe traumatic brain injury. Methods: Serum levels of Interleukin (IL)-1β, IL-4, IL-6, IL-10, IL-13 and TNF-α were investigated in patients with chronic disorder of consciousness and healthy volunteers. Correlations were carried out between GM, WM, and CSF volumes and inflammatory cytokines levels. In addition, the Coma Recovery Scale-Revised (CRS-R) score was used to quantify the severity, and long-term recovery clinical outcome at 12 month was determined according to Glasgow Outcome Scale (GOS).

Conditions

• Disorder of Consciousness

Timeline

• Start date: 2015-01-01
• Primary completion: 2022-12-01
• Completion: 2022-12-31
• First posted: 2019-04-09
• Last updated: 2024-05-07

Locations

1 site across 1 country: China