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

NCT ID: NCT03908541

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2022-12-31

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).

Conditions

Disorder of Consciousness

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benyan Luo, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology and Brain Medical Centre The First Affiliated Hospital, School of Medicine, Zhejiang University 79 Qingchun Road, Hangzhou

Locations

Hangzhou Hospital of Zhejiang CAPR

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

Chronic inflammation

Identifier Type: -

Identifier Source: org_study_id