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

First Affiliated Hospital of Zhejiang University200 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Disorder of Consciousness

Eligibility

Sex: ALLMin age: 14 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients ages 14 to 65 years old; 2. Patients had a history of sTBI; 3. Patients had awakened from a coma (indicating preserved sleep-wake cycles), including vegetative state and minimally consciousness state; 4. Patients stay unconscious for more than 1 month. Exclusion Criteria: 1. Patients with acute infectious diseases or liver dysfunction; 2. Patients with serious diseases such as cardiac or pulmonary problems.

Locations (1)

Hangzhou Hospital of Zhejiang CAPR

Hangzhou, Zhejiang, China

Outcomes

Primary Outcomes

Inflammatory cytokines

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.

Time frame: Six months

Secondary Outcomes

Gray matter volume

The study uses voxel-based morphometry (VBM) to measure changes of gray matter volume in patients with chronic disorder of consciousness and healthy volunteers.

Time frame: Six months

Coma Recovery Scale-Revised(CRS-R)

Coma Recovery Scale-Revised (CRS-R) score was used to quantify the severity, which consists of 23 hierarchically arranged items that comprise six subscales addressing auditory, visual, motor, oromotor/verbal, communication, and arousal processes. The lowest item on each subscale represents reflexive activity, whereas the highest items represent cognitively mediated behaviors.

Time frame: 30 minutes before blood collection

Glasgow Outcome Scale (GOS)

A GOS value of \<3 was considered as a bad recovery, while a GOS value of ≥3 was considered as a good recovery.

Time frame: In one year

Data from ClinicalTrials.gov

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