Proteomics for Chronic Disorder of Consciousness

NCT ID: NCT03611166

Last Updated: 2018-08-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-01
• Study Completion Date: 2020-01-15

Brief 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.

Detailed 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).

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

Jian Gao

Role: PRINCIPAL_INVESTIGATOR

Hangzhou Hospital of Zhejiang CAPR,Hangzhou, Zhejiang, China

Hai Zou

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Zhejiang Provincial People's Hospital, Hangzhou, PR China

Locations

Hangzhou Hospital of Zhejiang CAPR

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wangxiao Bao, PHD

Role: CONTACT

baowangxiao@zju.edu.cn

(86)15057137653

Fangping He, PHD

Role: CONTACT

hefangping@126.com

(86)13819114225

Facility Contacts

Wangxiao Bao, PHD

Role: primary

baowangxiao@zju.edu.cn

(86)15057137653

Other Identifiers

proteomics

Identifier Type: -

Identifier Source: org_study_id