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

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Zhejiang University

Status

Completed

Conditions

Disorder of Consciousness

Study type

Observational

Funder types

Other

Identifiers

NCT03908541
Chronic inflammation

Details and patient eligibility

About

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.

Full 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).

Enrollment

200 patients

Sex

All

Ages

14 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial contacts and locations

1

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Central trial contact

Fangping He, MS; Wangxiao Bao, PhD

Data sourced from clinicaltrials.gov

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