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

Disorder of Consciousness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03908541
• Other study ID #: Chronic inflammation
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2018
• Source: First Affiliated Hospital of Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 31, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Consciousness Disorders
• Disorder of Consciousness
• Inflammation

Locations

Country	Name	City	State
China	Hangzhou Hospital of Zhejiang CAPR	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory cytokines	Serum levels of Interleukin (IL)-1ß, IL-4, IL-6, IL-10, IL-13 and TNF-a were investigated in patients with chronic disorder of consciousness and healthy volunteers.	Six months
Secondary	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
Secondary	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
Secondary	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