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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03908541
Enrollment
200
Registered
2019-04-09
Start date
2015-01-01
Completion date
2022-12-31
Last updated
2024-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorder of Consciousness

Keywords

Inflammatory markers, Magnetic resonance imaging, disorder of consciousness

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).

Interventions

None listed

Sponsors

First Affiliated Hospital of Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Inflammatory cytokinesSix monthsSerum 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

MeasureTime frameDescription
Gray matter volumeSix monthsThe study uses voxel-based morphometry (VBM) to measure changes of gray matter volume in patients with chronic disorder of consciousness and healthy volunteers.
Coma Recovery Scale-Revised(CRS-R)30 minutes before blood collectionComa 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.
Glasgow Outcome Scale (GOS)In one yearA GOS value of \<3 was considered as a bad recovery, while a GOS value of ≥3 was considered as a good recovery.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026