Simultaneously PET/MRI in Prolonged DOC Patients

Disorder of Consciousness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04164680
• Other study ID #: 2019N55749
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: January 1, 2021

Study information

• Verified date: July 2022
• Source: Hangzhou Normal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Multimodal Neuroimaging
fludeoxyglucose (FDG-)PET/MR imaging

Locations

Country	Name	City	State
China	International Vegetative State and Consciousness Science Institute, Hangzhou Normal University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Normal University

Country where clinical trial is conducted

China, 

References & 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 Connectiv — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	resting-state fMRI	Use resting-state fMRI to test the functional connectivity	Within 7 days
Primary	fludeoxyglucose (FDG-)PET	UseFDG-PET to test the metabolism.	Within 7 days