the Prediction Value of Combined Electroencephalographic and Electromyographic Response in Disorders of Consciousness
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: thermal stimulation, itch.
- Who it may be relevant to
- Registry conditions: Disorders of Consciousness Due to Severe Brain Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Interventions
- Other thermal stimulation
contact heat stimulation at 54℃ - Other itch
itch the sole of the foot
Primary outcome measures
- the state of consciousness [Time frame: 6 months]
Secondary outcome measures (1)
- the score of GOSE [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06922864 · KY20242235jiangwen