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.

Study Overview

• Status: Unknown
• Conditions: 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).

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Wangxiao Bao, PHD; Phone Number: (86)15057137653; Email: baowangxiao@zju.edu.cn
• Study Contact Backup: Name: Fangping He, MS; Phone Number: (86)13819114225; Email: hefangping@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310001
      • Recruiting
      • Hangzhou Hospital of Zhejiang CAPR
      • Contact: Wangxiao Bao, PHD; Phone Number: (86)15057137653; Email: baowangxiao@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic disorder of consciousness were recruited at the rehabilitation units of Hangzhou Wujing Hospital (Hangzhou, Zhejiang, China).

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	In one year
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.	30 minutes before blood collection
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.	Six months

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University
• Investigators: Principal Investigator: Benyan Luo, PhD, Department of Neurology and Brain Medical Centre The First Affiliated Hospital, School of Medicine, Zhejiang University 79 Qingchun Road, Hangzhou

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: April 7, 2019
• First Submitted That Met QC Criteria: April 7, 2019
• First Posted (Actual): April 9, 2019

Study Record Updates

• Last Update Posted (Actual): April 9, 2019
• Last Update Submitted That Met QC Criteria: April 7, 2019
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Magnetic resonance imaging; Inflammatory markers; disorder of consciousness
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Disease; Inflammation; Consciousness Disorders
• Other Study ID Numbers: Chronic inflammation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No