Proteomics for Chronic Disorder of Consciousness

Disorder of Consciousness Clinical Trial

Official title:

iTRAQ-Based Proteomics Reveals Potential Biomarkers for Chronic Disorder of Consciousness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03611166
• Other study ID #: proteomics
• Status: Recruiting
• Start date: November 1, 2015
• Est. completion date: January 15, 2020

Study information

• Verified date: December 2017
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Wangxiao Bao, PHD
• Phone: (86)15057137653
• Email: baowangxiao[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Following severe traumatic brain injury, patients may remain unconscious for many years. It is the first proteomic analysis comparing differentially expressed proteins between patients with chronic disorder of consciousness and controls so far. The investigators generated accurate lists of proteomes and identified differences at different disease time courses. The obtained results provide new insight into understanding the molecular mechanisms underlying the chronic disorder of consciousness.

Description:

Background: Patients who awake from severely traumatic brain injury (sTBI) may remain unconscious for many years. Although behavioral assessment and functional imaging are currently used as diagnostic tools, the molecular basis underlying chronic condition has yet to be explored.

Objective:To explore the molecular basis and identify novel biomarkers for the diagnosis and prognosis of patients with chronic disorder of consciousness.

Method: Plasma samples were obtained from patients with chronic disorder of consciousness, and healthy volunteers. A coupled isobaric tag for relative and absolute quantitation (iTRAQ)-based proteomics approach was used to screen differentially expressed proteins (DEPs) between patients and controls. Potential molecular mechanisms were further discussed through bioinformatics analyses. Candidate proteins were validated by enzyme-linked immunosorbent assay (ELISA).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 15, 2020
• Est. primary completion date: June 15, 2019
• 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

• Chronic Disease
• Consciousness Disorders
• Disease
• Disorder of Consciousness

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	Protein profiling	A coupled isobaric tag for relative and absolute quantitation (iTRAQ)-based proteomics approach was used to screen differentially expressed proteins (DEPs) between patients and controls.	Three months
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
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