the Prediction Value of Combined Electroencephalographic and Electromyographic Response in Disorders of Consciousness

NCT06922864 | Not Yet Recruiting

• 1 other identifier: KY20242235jiangwen
• Study Type: observational
• Target: 36
• Locations: 0 countries
• Sites: N/A

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 stimulation is thermal and itch. Six months after inclusion in the study, patients were classified according to the Glasgow Outcome Scale Extended, (GOSE).

Conditions

Disorders of Consciousness Due to Severe Brain Injury

Outcome Measures

Primary Outcomes (1)

• the state of consciousness

  6 months

Secondary Outcomes (1)

• the score of GOSE

  6 months

Study Arms (2)

good outcome

not good outcome

Interventions

thermal stimulation OTHER

contact heat stimulation at 54℃

itch OTHER

itch the sole of the foot

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients wih disorders of consciousness in xijing hospital

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KY20242235jiangwen: lead

MeSH Terms

Interventions

UBE3A protein, human

Central Study Contacts

Hu

CONTACT

+86+15399059833; 304517021@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: head of department

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 11, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 11, 2025

Record last verified: 2025-04