NCT04164680

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 15, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

July 8, 2022

Status Verified

July 1, 2022

Enrollment Period

3 years

First QC Date

November 13, 2019

Last Update Submit

July 7, 2022

Conditions

Disorder of ConsciousnessMinimally Conscious StateFDG-PETRs-fMRI

Keywords

Disorder of ConsciousnessUnresponsive wakefulness syndromeMultimodal Neuroimaging

Outcome Measures

Primary Outcomes (2)

  • resting-state fMRI

    Use resting-state fMRI to test the functional connectivity

    Within 7 days

  • fludeoxyglucose (FDG-)PET

    UseFDG-PET to test the metabolism.

    Within 7 days

Study Arms (1)

Patients with disorders of consciousness

Diagnostic Test: Multimodal Neuroimaging

Interventions

Multimodal NeuroimagingDIAGNOSTIC_TEST

fludeoxyglucose (FDG-)PET/MR imaging

Patients with disorders of consciousness

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Hangzhou, Zhejiang, 3100036, China

Location

Related Publications (1)

  • 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.

    PMID: 30405513RESULT

MeSH Terms

Conditions

Consciousness DisordersPersistent Vegetative State

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesUnconsciousness

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

November 13, 2019

First Posted

November 15, 2019

Study Start

January 1, 2018

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

July 8, 2022

Record last verified: 2022-07

Locations

CN(1)