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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03475511
Other study ID # High-resolution MRI
Secondary ID
Status Recruiting
Phase
First received March 18, 2018
Last updated March 18, 2018
Start date October 15, 2016
Est. completion date January 15, 2020

Study information

Verified date November 2017
Source First Affiliated Hospital of Zhejiang University
Contact Xufei F Tan, PHD
Phone 13588101720
Email tanxf1002@163.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date January 15, 2020
Est. primary completion date June 15, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Hangzhou Hospital of Zhejiang CAPR Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Three months