Disorder of ConsciousnessNCT04164680
Simultaneously PET/MRI in Prolonged DOC Patients
An observational study of Disorder of Consciousness and Minimally Conscious State, run by Hangzhou Normal University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 16 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Disorder of Consciousness, Minimally Conscious State, FDG-PET
- What is being tested?
- Multimodal Neuroimaging
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- DOC patients （acute, subacute or chronic period）: Coma, UWS and MCS.
Who cannot join
- neuromuscular blocking agents or sedative drugs administered within the prior 24 hours；
- unstable medical condition；
- mental implant in the brain
Trial locations and contacts
1 site in 1 country.
China1 site
International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
Hangzhou, Zhejiang, 3100036
About this study
Official title: 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.
- Conditions
- Disorder of Consciousness, Minimally Conscious State, FDG-PET, Rs-fMRI
- Being tested
- Multimodal Neuroimaging
- Keywords
- Disorder of Consciousness, Unresponsive wakefulness syndrome, Multimodal Neuroimaging
- Medical subject headings
- Consciousness Disorders, Persistent Vegetative State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal NeuroimagingDiagnostic test
fludeoxyglucose (FDG-)PET/MR imaging
| Study group | Role | What they receive |
|---|---|---|
| Patients with disorders of consciousness | Not described Receives: Diagnostic Test: Multimodal Neuroimaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
resting-state fMRI
Use resting-state fMRI to test the functional connectivity
Measured: Within 7 days
fludeoxyglucose (FDG-)PET
UseFDG-PET to test the metabolism.
Measured: Within 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start1 Jan 2018
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disorder of ConsciousnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Wang, Hangzhou Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164680
- Sponsor's protocol ID
- 2019N55749
- Status last verified
- Jul 2022
- First submitted
- 13 Nov 2019
- Last updated
- 8 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Simultaneously Acquired Resting-state Regional Cerebral Glucose Metabolism and Functional MRI in DOC: a PET/MR Hybrid Scanner Study
- ClinicalTrials.gov ID
- NCT04164680
- Acronym / sponsor ID
- 2019N55749
- Conditions
- Disorder of Consciousness, Minimally Conscious State, FDG-PET, Rs-fMRI
- Keywords
- Disorder of Consciousness, Unresponsive wakefulness syndrome, Multimodal Neuroimaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hangzhou Normal UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with disorders of consciousness | – | Diagnostic Test: Multimodal Neuroimaging |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- DOC patients （acute, subacute or chronic period）: Coma, UWS and MCS.
Key exclusion criteria (3 listed)
- neuromuscular blocking agents or sedative drugs administered within the prior 24 hours；
- unstable medical condition；
- mental implant in the brain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal Neuroimagingfludeoxyglucose (FDG-)PET/MR imaging | Diagnostic test | Patients with disorders of consciousness |
Primary outcome
resting-state fMRI
Time frame: Within 7 days
Use resting-state fMRI to test the functional connectivity
fludeoxyglucose (FDG-)PET
Time frame: Within 7 days
UseFDG-PET to test the metabolism.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- Results publication: PubMed 30405513Cavaliere 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.
Related trials for Disorder of Consciousness
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Recruiting
Conscious Sedation Versus General Anesthesia for Pulsed Field Ablation in Paroxysmal Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Active, not recruiting
A Study to Evaluate the Effects of a Beef Liver Supplement on Energy, Mood, and Mental Clarity
Fatigue, Low Mood
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disorder of Consciousness and Minimally Conscious State, run by Hangzhou Normal University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
resting-state fMRI (time frame: Within 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04164680, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2022.