Clinical trial NCT03611166: Proteomics for Chronic Disorder of Consciousness
Official title: iTRAQ-Based Proteomics Reveals Potential Biomarkers for Chronic Disorder of Consciousness
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Disorder of Consciousness
Keywords: proteomics
plasma
chronic disorder of consciousness
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 200
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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).

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.

Primary outcomes:
measure: Protein profiling
timeFrame: Three months
Secondary outcomes:
measure: Glasgow Outcome Scale (GOS)
timeFrame: In one year
measure: Coma Recovery Scale-Revised(CRS-R)
timeFrame: 30 minutes before blood collection
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou Hospital of Zhejiang CAPR
state: Zhejiang
Study officials:
affiliation: Department of Neurology and Brain Medical Centre The First Affiliated Hospital, School of Medicine, Zhejiang University 79 Qingchun Road, Hangzhou
name: Benyan Luo, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hangzhou Hospital of Zhejiang CAPR,Hangzhou, Zhejiang, China
name: Jian Gao
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiology, Zhejiang Provincial People's Hospital, Hangzhou, PR China
name: Hai Zou
role: PRINCIPAL_INVESTIGATOR
References: