Clinical trial NCT03908541: Peripheral Inflammation and Brain Structural Alterations in Patients With Disorders of Consciousness.
Official title: Peripheral Inflammation and Brain Structural Alterations in Patients With Disorders of Consciousness.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disorder of Consciousness
Keywords: Inflammatory markers
Magnetic resonance imaging
disorder of consciousness
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2019-04-09
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: 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.

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).

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: Inflammatory cytokines
timeFrame: Six months
Secondary outcomes:
measure: Gray matter volume
timeFrame: Six months
measure: Coma Recovery Scale-Revised(CRS-R)
timeFrame: 30 minutes before blood collection
measure: Glasgow Outcome Scale (GOS)
timeFrame: In one year
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
References: