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

NCT03908541 | Completed DMC

• 1 other identifier: Chronic inflammation
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Disorder of Consciousness

Keywords

Inflammatory markers; Magnetic resonance imaging; disorder of consciousness

Outcome Measures

Primary Outcomes (1)

• Inflammatory cytokines

  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.

  Six months

Secondary Outcomes (3)

• Gray matter volume

  Six months

• Coma Recovery Scale-Revised(CRS-R)

  30 minutes before blood collection

• Glasgow Outcome Scale (GOS)

  In one year

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Patients ages 14 to 65 years old;
• Patients had a history of sTBI;
• Patients had awakened from a coma (indicating preserved sleep-wake cycles), including vegetative state and minimally consciousness state;
• Patients stay unconscious for more than 1 month.

You may not qualify if:

• Patients with acute infectious diseases or liver dysfunction;
• Patients with serious diseases such as cardiac or pulmonary problems.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

Hangzhou Hospital of Zhejiang CAPR

Hangzhou, Zhejiang, 310001, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood (5 mL) was collected in a Vacutainer® tube without anticoagulant, using standardized phlebotomy procedures. Serum was prepared by centrifugation (2,000 g, 5 min, 4°C) and stored at -80°C until further analysis.

MeSH Terms

Conditions

Consciousness Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Benyan Luo, PhD

  Department of Neurology and Brain Medical Centre The First Affiliated Hospital, School of Medicine, Zhejiang University 79 Qingchun Road, Hangzhou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2019
• First Posted: April 9, 2019
• Study Start: January 1, 2015
• Primary Completion: December 1, 2022
• Study Completion: December 31, 2022
• Last Updated: May 7, 2024

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)