Disorder of ConsciousnessNCT06097013
Study of Brain Function Evaluation System for Acute and Prolonged Disorders of Consciousness
An observational study of Disorder of Consciousness, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
The research focuses on establishing a system for detecting loss of consciousness, developing clinical prognostic and awakening-related brain function testing criteria. Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Disorder of Consciousness
- What is being tested?
- Routine clinical rehabilitation
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 13 Apr 2022to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: prolonged disorders of consciousness and acute disorders of consciousness
Who may be able to join
- Age 14-60 years;
- In accordance with the diagnostic criteria of unresponsive arousal syndrome or minimally conscious state by international research;
- Brain Trauma, stroke and hypoxic-ischemic encephalopathy lead to disturbance of consciousness;
- right-handed；
- The patient's family members signed the informed consent form;
- (1)Age 14-60 years; (2）Meets diagnostic criteria for coma recognized in international studies； (3)the GCS score was less than 8; (4)Brain Trauma, stroke and hypoxic-ischemic encephalopathy lead to disturbance of consciousness; (5) right-handed； (6)The patient's family members signed the informed consent form;
Who cannot join
- The history of mental illness and a history of hearing impairment;
- Intracranial arterial clamp, pacemaker and other metal implants;
- During the experiment, sedatives and other drugs that affect the excitability of the cortex;
- The presence of uncontrolled seizures or involuntary movements;
- Admission criteria for patients with acute disorders of consciousness
- The history of mental illness and a history of hearing impairment;
Show all 12Show fewer
- Intracranial arterial clamp, pacemaker and other metal implants;
- During the experiment, sedatives and other drugs that affect the excitability of the cortex;
- The presence of uncontrolled seizures or involuntary movements; Admission criteria for patients with acute disorders of consciousness;
- No spontaneous breathing;
- Status Epilepticus;
- Need emergency neurosurgical treatment can not cooperate with the examination;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Science and Technology Innovation 2030
The research focuses on establishing a system for detecting loss of consciousness, developing clinical prognostic and awakening-related brain function testing criteria.
Read the detailed description
A framework for the acquisition of neural features, feature selection and mechanism analysis of consciousness deficits in patients with acute and prolonged disorders of consciousness(DOC). Based on the multimodal data of three types of patients with DOC, the investigators established a comprehensive scientific collection of brain function features of acute and prolonged consciousness disorders; Revealed the key neural nodes and circuits of consciousness deficits, and elucidated the neural mechanisms of consciousness deficits in patients with prolonged consciousness disorders from EEG time-frequency-spatial features;
- Conditions
- Disorder of Consciousness
- Being tested
- Routine clinical rehabilitation
- Keywords
- Brain Function Test
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine clinical rehabilitationOther
Routine clinical rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Prolonged disorders of consciousness | Admission criteria for patients with prolonged disorders of consciousness Inclusion Criteria Receives: Other: Routine clinical rehabilitation | |
| Acute disorders of consciousness | Admission criteria for patients with acute disorders of consciousness Inclusion Criteria Receives: Other: Routine clinical rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Coma recovery scale-revised
CRS-R scale includes 6 dimensions such as audiovisual, arousal level, verbal response, motor and communication, scoring 0 to 23, the higher the score the better the neurological function, and each score reflects the presence or absence of the evaluated person and the strength of consciousness
Measured: Within 24 hours of enrollment
Change from the p300 in electroencephalogram
Assessment the p300 in event related potential(ERP)
Measured: Assessment within 24 hours before, and 1 hour after TMS treatment
Change from resting-state in electroencephalogram
Assessment the spectral power and coherence by in resting-state EEG
Measured: Assessment within 24 hours before, and 1 hour after TMS treatment
Change from TEP in electroencephalogram
Assessment the TMS Evoked Potential(TEP)
Measured: Assessment within 24 hours before, and 1 hour after TMS treatment
Change from PCI in electroencephalogram
Assessment the perturbational complexity index(PCI) in TMS-EEG
Measured: Assessment within 24 hours before, and 1 hour after TMS treatment
Secondary outcomes (1)
Change from ROI in neuroimage techniques-PET
The distribution of 18F-FDG in the brain was analyzed according to the imaging situation, and the brain regions of interest (ROI) were outlined, and the uptake of 18F-deoxyglucose (FDG) in the patients was observed according to the brain ROI.
Measured: Assessment within 24 hours before ,and 1 hour after TMS treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start13 Apr 2022
- Primary completionAug 2024 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin University, Jilin University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097013
- Sponsor's protocol ID
- 2021ZD0204300
- Status last verified
- Aug 2023
- First submitted
- 18 Oct 2023
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Science and Technology Innovation 2030
- ClinicalTrials.gov ID
- NCT06097013
- Acronym / sponsor ID
- 2021ZD0204300
- Conditions
- Disorder of Consciousness
- Keywords
- Brain Function Test
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- Tianjin University, Jilin University
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 24 Oct 2023 (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.
The research focuses on establishing a system for detecting loss of consciousness, developing clinical prognostic and awakening-related brain function testing criteria.
Detailed description
A framework for the acquisition of neural features, feature selection and mechanism analysis of consciousness deficits in patients with acute and prolonged disorders of consciousness(DOC). Based on the multimodal data of three types of patients with DOC, the investigators established a comprehensive scientific collection of brain function features of acute and prolonged consciousness disorders; Revealed the key neural nodes and circuits of consciousness deficits, and elucidated the neural mechanisms of consciousness deficits in patients with prolonged consciousness disorders from EEG time-frequency-spatial features;
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged disorders of consciousness | – | Other: Routine clinical rehabilitationAdmission criteria for patients with prolonged disorders of consciousness Inclusion Criteria |
| Acute disorders of consciousness | – | Other: Routine clinical rehabilitationAdmission criteria for patients with acute disorders of consciousness Inclusion Criteria |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- prolonged disorders of consciousness and acute disorders of consciousness
Key inclusion criteria (6 listed)
- Age 14-60 years;
- In accordance with the diagnostic criteria of unresponsive arousal syndrome or minimally conscious state by international research;
- Brain Trauma, stroke and hypoxic-ischemic encephalopathy lead to disturbance of consciousness;
- right-handed；
- The patient's family members signed the informed consent form;
Key exclusion criteria (12 listed)
- The history of mental illness and a history of hearing impairment;
- Intracranial arterial clamp, pacemaker and other metal implants;
- During the experiment, sedatives and other drugs that affect the excitability of the cortex;
- The presence of uncontrolled seizures or involuntary movements;
- Admission criteria for patients with acute disorders of consciousness
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 |
|---|---|---|
| Routine clinical rehabilitationRoutine clinical rehabilitation | Other | Acute disorders of consciousness, Prolonged disorders of consciousness |
Primary outcome
Change from Coma recovery scale-revised
Time frame: Within 24 hours of enrollment
CRS-R scale includes 6 dimensions such as audiovisual, arousal level, verbal response, motor and communication, scoring 0 to 23, the higher the score the better the neurological function, and each score reflects the presence or absence of the evaluated person and the strength of consciousness
Change from the p300 in electroencephalogram
Time frame: Assessment within 24 hours before, and 1 hour after TMS treatment
Assessment the p300 in event related potential(ERP)
Change from resting-state in electroencephalogram
Time frame: Assessment within 24 hours before, and 1 hour after TMS treatment
Assessment the spectral power and coherence by in resting-state EEG
Change from TEP in electroencephalogram
Time frame: Assessment within 24 hours before, and 1 hour after TMS treatment
Assessment the TMS Evoked Potential(TEP)
Change from PCI in electroencephalogram
Time frame: Assessment within 24 hours before, and 1 hour after TMS treatment
Assessment the perturbational complexity index(PCI) in TMS-EEG
1 secondary outcome
Change from ROI in neuroimage techniques-PET
Time frame: Assessment within 24 hours before ,and 1 hour after TMS treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- 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.
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, run by Xuanwu Hospital, Beijing 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 6 inclusion and 12 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: enrolling by invitation, as of the sponsor's last update on 22 Jul 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change from Coma recovery scale-revised (time frame: Within 24 hours of enrollment). The study lists 5 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 22 Jul 2024.