Peripheral Inflammation and Brain Structural Alterations in Patients With Disorders of Consciousness.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Disorder of Consciousness
- Sponsor
- First Affiliated Hospital of Zhejiang University
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Inflammatory cytokines
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients ages 14 to 65 years old;
- •Patients had a history of sTBI;
- •Patients had awakened from a coma (indicating preserved sleep-wake cycles), including vegetative state and minimally consciousness state;
- •Patients stay unconscious for more than 1 month.
Exclusion Criteria
- •Patients with acute infectious diseases or liver dysfunction;
- •Patients with serious diseases such as cardiac or pulmonary problems.
Outcomes
Primary Outcomes
Inflammatory cytokines
Time Frame: Six months
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.
Secondary Outcomes
- Gray matter volume(Six months)
- Coma Recovery Scale-Revised(CRS-R)(30 minutes before blood collection)
- Glasgow Outcome Scale (GOS)(In one year)