Simultaneously PET/MRI in Prolonged DOC Patients

July 7, 2022 updated by: Jing Wang, Hangzhou Normal University

Relationship Between Simultaneously Acquired Resting-state Regional Cerebral Glucose Metabolism and Functional MRI in DOC: a PET/MR Hybrid Scanner Study

Recently introduced hybrid PET/MR scanners provide the opportunity to measure simultaneously, and in direct spatial correspondence, both metabolic demand and functional activity of the brain, hence capturing complementary information on the brain's physiological state. Here we exploited PET/MR simultaneous imaging to explore the relationship between the metabolic information provided by resting-state fluorodeoxyglucose-PET (FDG-PET) and fMRI (rs-fMRI) in patients with disorders of consciousness.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 3100036
        • International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Distinguishing patients in unresponsive wakefulness syndrome, UWS [i.e. patients showing eyes opening but no behavioral evidence of consciousness ] from patients in minimally conscious state, MCS [i.e., patients showing minimal, inconsistent but clearly discernible intentional behaviors ] is pivotal for decision making in the entire care pathway of patients with DoC.

Description

Inclusion Criteria:

  • DOC patients （acute, subacute or chronic period）: Coma, UWS and MCS.

Exclusion Criteria:

  • neuromuscular blocking agents or sedative drugs administered within the prior 24 hours；
  • unstable medical condition；
  • mental implant in the brain

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with disorders of consciousness
Diagnostic test: Multimodal Neuroimaging
fludeoxyglucose (FDG-)PET/MR imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
resting-state fMRI
Time Frame: Within 7 days
Use resting-state fMRI to test the functional connectivity
Within 7 days
fludeoxyglucose (FDG-)PET
Time Frame: Within 7 days
UseFDG-PET to test the metabolism.
Within 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hangzhou Normal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2018

Primary Completion (ACTUAL)

January 1, 2021

Study Completion (ACTUAL)

January 1, 2021

Study Registration Dates

First Submitted

November 13, 2019

First Submitted That Met QC Criteria

November 13, 2019

First Posted (ACTUAL)

November 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 8, 2022

Last Update Submitted That Met QC Criteria

July 7, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019N55749

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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