Disorders of ConsciousnessNCT05558670
Brain Network Characteristics in Patients With Disorders of Consciousness
An observational study of Disorders of Consciousness, run by Xijing Hospital at 1 site in China.
Trial summary
Simultaneous measurement of the three modalities, functional magnetic resonance imaging (fMRI), positron emission tomography (PET) and electroencephalography (EEG) was proven to be feasible and advantageous in evaluating brain structural and functional (via fMRI), metabolic (via PET) and electrophysiological (via EEG)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disorders of Consciousness
- What is being tested?
- PET-fMRI-EEG
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Sep 2022to Oct 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants are selected in patients hospitalised in neurology department of Xijing hospital
Who may be able to join
- Coma, VS/UWS, MCS and EMCS according to diagnostic criteria
- Age ≥18 years
- Written informed consent obtained
Who cannot join
- Patients with contraindications to PET, MRI, EEG examinations or inability to complete PET-fMRI-EEG examinations (presence of ferromagnetic metal implants or hyperthermia)
- Hyperglycemia that is difficult to correct
- Patients with long-term use of corticosteroids
- Patients with coexisting severe systemic disease and limited life expectancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing hospital
Xi'an, Shaanxi, 710032
Rong Chen, 18292575563, cmuchenrong@126.com
About this study
Official title: Assessing Brain Network Characteristics in Patients With Disorders of Consciousness by Simultaneous Trimodal Positron Emission Tomography-Functional Magnetic Resonance Imaging-Electroencephalograph（PET-fMRI-EEG）Imaging
Simultaneous measurement of the three modalities, functional magnetic resonance imaging (fMRI), positron emission tomography (PET) and electroencephalography (EEG) was proven to be feasible and advantageous in evaluating brain structural and functional (via fMRI), metabolic (via PET) and electrophysiological (via EEG) signatures simultaneously under the same conditions. Investigators use trimodal PET-fMRI-EEG imaging to explore the characteristics of brain network damage in patients with disorders of consciousness(DOC), assess the trajectory of consciousness recovery in a prospective observational cohort study.
- Conditions
- Disorders of Consciousness
- Being tested
- PET-fMRI-EEG
- Keywords
- PET-fMRI-EEG, brain network, coma, Vegetative state(VS), Unresponsive wakefulness syndrome (UWS), Minimally conscious state(MCS), Emerged from minimally conscious state(EMCS)
- Medical subject headings
- Consciousness Disorders, Coma, Persistent Vegetative State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-fMRI-EEGOther
Participants perform PET, fMRI, and EEG simultaneously using a MRI compatible EEG cap
| Study group | Role | What they receive |
|---|---|---|
| coma | Not described Receives: Other: PET-fMRI-EEG | |
| VS/UWS | Not described Receives: Other: PET-fMRI-EEG | |
| MCS | Not described Receives: Other: PET-fMRI-EEG | |
| EMCS | Not described Receives: Other: PET-fMRI-EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRS-R total score
The coma recovery scale-revised(CRS-R) total score is used to measure level of consciousness of disorder in enrolled patients. CRS-R consists of six subscales addressing auditory, visual, motor, verbal, communication, and arousal functions.The lowest item on each subscale represents reflexive activity and the highest item represents cognitively mediated behavior. Maximum scores of each subscale are summed to obtain the total score (from 0 to 23).The score for each subscale is based on the presence or absence of a specific behavioral response to a sensory stimulus (higher scores are better).
Measured: Patients in coma after 3 weeks enrolled
GOSE score
Glasgow Outcome Scale-Extended(GOSE) score is used to measure the functional limitations of participants. GOSE is a 1-8 point scale (1 = Death, 2 = Vegetative State, 3 = Lower Severe Disability, 4 = Upper Severe Disability, 5 = Lower Moderate Disability, 6 = Upper Moderate Disability, 7 = Lower Good Recovery, and 8 = Upper Good Recovery). Patients with higher scores are more independent.
Measured: Patients are followed up for 6 months after enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study startSep 2022 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorders of ConsciousnessStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen Jiang, Study director, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558670
- Sponsor's protocol ID
- 20222068
- Status last verified
- Aug 2022
- First submitted
- 1 Sep 2022
- Last updated
- 28 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Brain Network Characteristics in Patients With Disorders of Consciousness by Simultaneous Trimodal Positron Emission Tomography-Functional Magnetic Resonance Imaging-Electroencephalograph（PET-fMRI-EEG）Imaging
- ClinicalTrials.gov ID
- NCT05558670
- Acronym / sponsor ID
- 20222068
- Conditions
- Disorders of Consciousness
- Keywords
- PET-fMRI-EEG, brain network, coma, Vegetative state(VS), Unresponsive wakefulness syndrome (UWS), Minimally conscious state(MCS), Emerged from minimally conscious state(EMCS)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 28 Sep 2022 (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.
Simultaneous measurement of the three modalities, functional magnetic resonance imaging (fMRI), positron emission tomography (PET) and electroencephalography (EEG) was proven to be feasible and advantageous in evaluating brain structural and functional (via fMRI), metabolic (via PET) and electrophysiological (via EEG) signatures simultaneously under the same conditions. Investigators use trimodal PET-fMRI-EEG imaging to explore the characteristics of brain network damage in patients with disorders of consciousness(DOC), assess the trajectory of consciousness recovery in a prospective observational cohort study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| coma | – | Other: PET-fMRI-EEG |
| VS/UWS | – | Other: PET-fMRI-EEG |
| MCS | – | Other: PET-fMRI-EEG |
| EMCS | – | Other: PET-fMRI-EEG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are selected in patients hospitalised in neurology department of Xijing hospital
Key inclusion criteria (3 listed)
- Coma, VS/UWS, MCS and EMCS according to diagnostic criteria
- Age ≥18 years
- Written informed consent obtained
Key exclusion criteria (4 listed)
- Patients with contraindications to PET, MRI, EEG examinations or inability to complete PET-fMRI-EEG examinations (presence of ferromagnetic metal implants or hyperthermia)
- Hyperglycemia that is difficult to correct
- Patients with long-term use of corticosteroids
- Patients with coexisting severe systemic disease and limited life expectancy
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 |
|---|---|---|
| PET-fMRI-EEGParticipants perform PET, fMRI, and EEG simultaneously using a MRI compatible EEG cap | Other | EMCS, MCS, VS/UWS, coma |
Primary outcome
CRS-R total score
Time frame: Patients in coma after 3 weeks enrolled
The coma recovery scale-revised(CRS-R) total score is used to measure level of consciousness of disorder in enrolled patients. CRS-R consists of six subscales addressing auditory, visual, motor, verbal, communication, and arousal functions.The lowest item on each subscale represents reflexive activity and the highest item represents cognitively mediated behavior. Maximum scores of each subscale are summed to obtain the total score (from 0 to 23).The score for each subscale is based on the presence or absence of a specific behavioral response to a sensory stimulus (higher scores are better).
GOSE score
Time frame: Patients are followed up for 6 months after enrolled
Glasgow Outcome Scale-Extended(GOSE) score is used to measure the functional limitations of participants. GOSE is a 1-8 point scale (1 = Death, 2 = Vegetative State, 3 = Lower Severe Disability, 4 = Upper Severe Disability, 5 = Lower Moderate Disability, 6 = Upper Moderate Disability, 7 = Lower Good Recovery, and 8 = Upper Good Recovery). Patients with higher scores are more independent.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Wen Jiang study director
Xijing Hospital
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 Disorders of Consciousness, run by Xijing Hospital 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rong Chen (18292575563, cmuchenrong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRS-R total score (time frame: Patients in coma after 3 weeks enrolled). 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?
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 28 Sep 2022.