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).

Study Overview

• Status: Not yet recruiting
• Conditions: Disorders of Consciousness Due to Severe Brain Injury
• Intervention / Treatment: Other: thermal stimulation; Other: itch

• Study Type: Observational
• Enrollment (Estimated): 36

Contacts and Locations

• Study Contact: Name: Hu; Phone Number: +86+15399059833; Email: 304517021@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients wih disorders of consciousness in xijing hospital

Description

Inclusion Criteria:

1. Age ≥18 years.
2. Brain damage lasts 28 to 90 days.

3. 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.

4. All subjects' legal guardians sign informed consent forms.

Exclusion Criteria:

1. Spinal cord T1 and above plane injury, peripheral nerve injury and so on affect nerve conduction;
2. The impact of injury on palms and soles of feet;
3. History of developmental, psychiatric, or neurological disorders prior to brain injury.
4. Deep sedation within 72 hours, including the use of general anesthesia.
5. Increased intracranial pressure, liver/kidney failure, and hemodynamic instability within 72 hours.
6. Severe co-existing systemic diseases with limited life expectancy.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
good outcome
not good outcome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the state of consciousness	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
the score of GOSE	6 months

Collaborators and Investigators

• Sponsor: KY20242235jiangwen

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 3, 2025
• First Submitted That Met QC Criteria: April 3, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Wounds and Injuries; Neurobehavioral Manifestations; Neurocognitive Disorders; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Consciousness Disorders
• Other Study ID Numbers: KY20242235jiangwen

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No