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

NCT ID: NCT03475511

Last Updated: 2018-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-15

Study Completion Date

2020-01-15

Brief Summary

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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.

Detailed Description

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Conditions

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High-resolution Magnetic Resonance Imaging; Disorders of Consciousness

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benyan F Luo, MD

Role: 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

Role: PRINCIPAL_INVESTIGATOR

Hangzhou Hospital of Zhejiang CAPR,Hangzhou, Zhejiang, China

Locations

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Hangzhou Hospital of Zhejiang CAPR

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xufei F Tan, PHD

Role: CONTACT

13588101720

Ruili M Wei, MD

Role: CONTACT

13750858091

Facility Contacts

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Xufei Tan

Role: primary

Other Identifiers

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High-resolution MRI

Identifier Type: -

Identifier Source: org_study_id

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