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Clinical Trials/NCT03475511
NCT03475511
Unknown
Not Applicable

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

First Affiliated Hospital of Zhejiang University1 site in 1 country60 target enrollmentOctober 15, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
High-resolution Magnetic Resonance Imaging; Disorders of Consciousness
Sponsor
First Affiliated Hospital of Zhejiang University
Enrollment
60
Locations
1
Primary Endpoint
Diffusion magnetic resonance imaging analysis
Last Updated
8 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
October 15, 2016
End Date
January 15, 2020
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
First Affiliated Hospital of Zhejiang University
Responsible Party
Sponsor

Eligibility Criteria

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

  • Magnetic resonance contraindications

Outcomes

Primary Outcomes

Diffusion magnetic resonance imaging analysis

Time Frame: Three months

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

Study Sites (1)

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