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NCT Number: NCT06922864

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

thermal stimulation

Other

contact heat stimulation at 54℃

itch

Other

itch the sole of the foot

Primary outcomes

  1. the state of consciousness

    Time frame: 6 months

Secondary outcomes

  1. the score of GOSE

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Hu

CONTACT

[email protected]

+86+15399059833

Sponsors and collaborators

Lead sponsor

KY20242235jiangwen

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 11, 2025
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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