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Status unknownNCT03475511Updated Mar 23, 2018

The Usage of High-resolution Magnetic Resonance Imaging in Patients With Disorders of Consciousness for Early Diagnosis

An observational study in High-resolution Magnetic Resonance Imaging; Disorders of Consciousness, sponsored by First Affiliated Hospital of Zhejiang University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-03-23.

Sponsored by First Affiliated Hospital of Zhejiang University · Observational

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 80 Years
Sex
All
01

Study summary

In this study, high-resolution brain functional magnetic resonance imaging (MRI) was used to evaluate the differences in brain structure and brain function network between patients with different degrees of disturbance of cognition and healthy controls by means of cohort follow-up and control study. The changes of patients' The dynamic changes of learning, to explore its clinical value as an early diagnosis. Combined with neurobehavioral scales and high-resolution brain structure, functional magnetic resonance imaging data to assess the brain structure, functional characteristics and consciousness of patients with impaired consciousness, and initially establish awareness of patients with recovery of consciousness Predictable imaging signs. Twenty eligible controls, 20 VS patients, and 20 MCS patients will be considered for inclusion in the inclusion / exclusion criteria. Informed consent will be obtained as required before starting any registration process.

02

Conditions studied

  • High-resolution Magnetic Resonance Imaging; Disorders of Consciousness
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

These patients were admitted to the Department of Rehabilitation at Hangzhou Hospital of Zhejiang CAPR.

Inclusion criteria

(1) no use of centrally acting drugs, (2) no use of neuromuscular function blockers and no sedation within the prior 24 h, (3) periods of eye opening indicating a preserved sleep-wake cycle, and (4) a diagnosis of VS or MCS established according to internationally established criteria

Exclusion criteria

Exclusion Criteria:

Magnetic resonance contraindications

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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes
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What researchers measure

Primary outcomes

  1. Diffusion magnetic resonance imaging analysis

    The color-coding of tractography pathways in was determined for a visualization purpose. The color-coding of tractography pathways was based on FA values.

    Time frame: Three months

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Study locations

1 of 1 sites recruiting
  • Hangzhou Hospital of Zhejiang CAPR
    Hangzhou, Zhejiang, China
    • Xufei Tan · Contact · tanxf1002@163.com
    • Kehong Liu · Principal investigator
    • Jian Gao · Principal investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT03475511
Lead sponsor
First Affiliated Hospital of Zhejiang University
Responsible party
Sponsor
First posted
Mar 23, 2018
Start date
Oct 15, 2016
Primary completion
Jun 15, 2019 (estimated)
Completion
Jan 15, 2020 (estimated)
Last update
Mar 23, 2018

Study contacts

Xufei F Tan, PHD
Contact
tanxf1002@163.com
13588101720
Ruili M Wei, MD
Contact
weelly@163.com
13750858091
Benyan F Luo, MD
principal investigator · Department of Neurology and Brain Medical Centre The First Affiliated Hospital, School of Medicine, Zhejiang University 79 Qingchun Road, Hangzhou
Jian M Gao
principal investigator · Hangzhou Hospital of Zhejiang CAPR,Hangzhou, Zhejiang, China

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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