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NCT Number: NCT03908541

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

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.

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Key information

Conditions

Disorder of Consciousness Consciousness Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

14 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hangzhou Hospital of Zhejiang CAPR

Hangzhou, Zhejiang, 310001, China

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. Gray matter volume

    Time frame: Six months

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

  2. Coma Recovery Scale-Revised(CRS-R)

    Time frame: 30 minutes before blood collection

    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.

  3. Glasgow Outcome Scale (GOS)

    Time frame: In one year

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

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Apr 9, 2019
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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