NCT02999490

Brief Summary

Clinical examinations are difficult to discriminate between vegetative state and minimally conscious state. the diagnostic and prognostic usefulness of neuroimaging methods has not been established in a clinical setting. we will do a forward study of PET imaging in disorders of consciousness patients, and validate with clinical assessments with the coma recovery Scale-Revised(CRS-R).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

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

March 1, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2016

Completed
9 months until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2017

Completed
Last Updated

April 20, 2018

Status Verified

April 1, 2018

Enrollment Period

1.8 years

First QC Date

March 25, 2016

Last Update Submit

April 19, 2018

Conditions

Persistent Vegetative State

Outcome Measures

Primary Outcomes (1)

  • standardized uptake value

    60 mins after injecting 18F-FDG

Study Arms (2)

Controls

NO INTERVENTION

The controls are intravenous injected of 185 to 370 MBq 18F-FDG.Then,the controls sleep for an hour in a quiet room before scanning.

Patients

EXPERIMENTAL

The patients are intravenous injected of 185 to 370 MBq 18F-FDG.Then,the patients sleep for an hour in a quiet room before scanning.

Radiation: 18F-FDG

Interventions

18F-FDGRADIATION

18F-FDG is positron emission tomography imaging agent which is already widely used in PET/CT examination.

Patients

Eligibility Criteria

Age10 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of disorder of consciousness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The PET/CT Centre Guangzhou General Hospital of Guangzhou Military Command

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Persistent Vegetative State

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydrates

Study Officials

  • Yin Jilin

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 25, 2016

First Posted

December 21, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 5, 2017

Last Updated

April 20, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will share

Locations

CN(1)