Status:
NOT_YET_RECRUITING
the Prediction Value of Combined Electroencephalographic and Electromyographic Response in Disorders of Consciousness
Lead Sponsor:
KY20242235jiangwen
Conditions:
Disorders of Consciousness Due to Severe Brain Injury
Eligibility:
All Genders
18+ years
Brief 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 stimulatio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 15 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06922864
Start Date
April 15 2025
End Date
December 31 2026
Last Update
April 11 2025
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