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CompletedNCT04164680Updated Jul 8, 2022

Simultaneously PET/MRI in Prolonged DOC Patients

An observational study in Disorder of Consciousness, Minimally Conscious State and FDG-PET, sponsored by Hangzhou Normal University. Completed at 1 site in China. Open to participants aged 16 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-08.

Sponsored by Hangzhou Normal University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
24
Ages
16 Years to 80 Years
Sex
All
01

Study summary

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.

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Conditions studied

  • Disorder of Consciousness
  • Minimally Conscious State
  • FDG-PET
  • Rs-fMRI

Keywords

  • Disorder of Consciousness
  • Unresponsive wakefulness syndrome
  • Multimodal Neuroimaging
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In context

Consciousness Disorders

290 studies on the registry are indexed under Consciousness Disorders; 109 are open to participants now.

This study's enrollment of 24 is below the median of 79 across 95 observational studies indexed under Consciousness Disorders.

Browse Consciousness Disorders studies →

Lead sponsor

Hangzhou Normal University is the lead sponsor of 22 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
24 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with disorders of consciousness

    Diagnostic Test: Multimodal Neuroimaging

Interventions

  • Diagnostic testMultimodal Neuroimaging

    fludeoxyglucose (FDG-)PET/MR imaging

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What researchers measure

Primary outcomes

  1. resting-state fMRI

    Use resting-state fMRI to test the functional connectivity

    Time frame: Within 7 days

  2. fludeoxyglucose (FDG-)PET

    UseFDG-PET to test the metabolism.

    Time frame: Within 7 days

07

Study locations

1 site
  • International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
    Hangzhou, Zhejiang 3100036, China
08

References and documents

Publications

  • Cavaliere C, Kandeepan S, Aiello M, Ribeiro de Paula D, Marchitelli R, Fiorenza S, Orsini M, Trojano L, Masotta O, St Lawrence K, Loreto V, Chronik BA, Nicolai E, Soddu A, Estraneo A. Multimodal Neuroimaging Approach to Variability of Functional Connectivity in Disorders of Consciousness: A PET/MRI Pilot Study. Front Neurol. 2018 Oct 18;9:861. doi: 10.3389/fneur.2018.00861. eCollection 2018. PubMed 30405513 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04164680
Lead sponsor
Hangzhou Normal University
Responsible party
Jing Wang (Dr., Hangzhou Normal University) — Principal investigator
First posted
Nov 15, 2019
Start date
Jan 1, 2018
Primary completion
Jan 1, 2021
Completion
Jan 1, 2021
Last update
Jul 8, 2022

Oversight

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

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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