Disorders of Consciousness Due to Severe Brain InjuryNCT06922864
the Prediction Value of Combined Electroencephalographic and Electromyographic Response in Disorders of Consciousness
An observational study of Disorders of Consciousness Due to Severe Brain Injury, run by KY20242235jiangwen.
Trial summary
The goal of this observation study is to learn about the prediction value of combined electroencephalographic and electromyographic response in disorders of consciousness. The main ways of stimulation is thermal and itch. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disorders of Consciousness Due to Severe Brain Injury
- What is being tested?
- thermal stimulation and itch
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2025to 31 Dec 2026
- How long will I take part?
- 6 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients wih disorders of consciousness in xijing hospital
Who may be able to join
- Age ≥18 years.
- Brain damage lasts 28 to 90 days.
- It meets the diagnostic criteria of unresponsive arousal syndrome/vegetative state (UWS/VS) or microconscious state (MCS).
- Diagnostic criteria for UWS/VS: loss of cognitive function and inability to execute commands; There is a sleep-wake cycle; Inability to understand or express language; The ability to open eyes automatically or in response to stimulation; Can be purposeless eye following movement; The functions of hypothalamus and brainstem were basically preserved.
- MCS diagnostic criteria: simple instructions can be executed; Yes/no (whether correct or not) can be expressed by gesture or speech; Have an understandable language; Purposeful behavior (including activity or emotional response) with more than one can diagnose MCS.
- All subjects' legal guardians sign informed consent forms.
Who cannot join
- Spinal cord T1 and above plane injury, peripheral nerve injury and so on affect nerve conduction;
- The impact of injury on palms and soles of feet;
- History of developmental, psychiatric, or neurological disorders prior to brain injury.
- Deep sedation within 72 hours, including the use of general anesthesia.
- Increased intracranial pressure, liver/kidney failure, and hemodynamic instability within 72 hours.
- Severe co-existing systemic diseases with limited life expectancy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this observation study is to learn about the prediction value of combined electroencephalographic and electromyographic response in disorders of consciousness.
The main ways of stimulation is thermal and itch. Six months after inclusion in the study, patients were classified according to the Glasgow Outcome Scale Extended, (GOSE).
- Being tested
- thermal stimulation, itch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thermal stimulationOther
contact heat stimulation at 54℃
itchOther
itch the sole of the foot
| Study group | Role | What they receive |
|---|---|---|
| good outcome | Not described | |
| not good outcome | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
the state of consciousness
Measured: 6 months
Secondary outcomes (1)
the score of GOSE
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start15 Apr 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorders of Consciousness Due to Severe Brain InjuryStudies 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
- 36 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- KY20242235jiangwen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, KY20242235jiangwen, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922864
- Sponsor's protocol ID
- KY20242235jiangwen
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Prediction Value of Combined Electroencephalographic and Electromyographic Response in Disorders of Consciousness
- ClinicalTrials.gov ID
- NCT06922864
- Acronym / sponsor ID
- KY20242235jiangwen
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- KY20242235jiangwenUniversity, hospital or other
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Apr 2025 (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 goal of this observation study is to learn about the prediction value of combined electroencephalographic and electromyographic response in disorders of consciousness.
The main ways of stimulation is thermal and itch. Six months after inclusion in the study, patients were classified according to the Glasgow Outcome Scale Extended, (GOSE).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| good outcome | – | – |
| not good outcome | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients wih disorders of consciousness in xijing hospital
Key inclusion criteria (6 listed)
- Age ≥18 years.
- Brain damage lasts 28 to 90 days.
- It meets the diagnostic criteria of unresponsive arousal syndrome/vegetative state (UWS/VS) or microconscious state (MCS).
- Diagnostic criteria for UWS/VS: loss of cognitive function and inability to execute commands; There is a sleep-wake cycle; Inability to understand or express language; The ability to open eyes automatically or in response to stimulation; Can be purposeless eye following movement; The functions of hypothalamus and brainstem were basically preserved.
- MCS diagnostic criteria: simple instructions can be executed; Yes/no (whether correct or not) can be expressed by gesture or speech; Have an understandable language; Purposeful behavior (including activity or emotional response) with more than one can diagnose MCS.
Key exclusion criteria (6 listed)
- Spinal cord T1 and above plane injury, peripheral nerve injury and so on affect nerve conduction;
- The impact of injury on palms and soles of feet;
- History of developmental, psychiatric, or neurological disorders prior to brain injury.
- Deep sedation within 72 hours, including the use of general anesthesia.
- Increased intracranial pressure, liver/kidney failure, and hemodynamic instability within 72 hours.
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 |
|---|---|---|
| thermal stimulationcontact heat stimulation at 54℃ | Other | – |
| itchitch the sole of the foot | Other | – |
Primary outcome
the state of consciousness
Time frame: 6 months
1 secondary outcome
the score of GOSE
Time frame: 6 months
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 11 Apr 2025.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Disorders of Consciousness Due to Severe Brain Injury, run by KY20242235jiangwen.
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 6 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: opening soon, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Hu (+86+15399059833, 304517021@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the state of consciousness (time frame: 6 months). 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 11 Apr 2025.