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

NCT ID: NCT06922864

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2026-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

good outcome

No interventions assigned to this group

not good outcome

No interventions assigned to this group

Interventions

thermal stimulation

contact heat stimulation at 54℃

Intervention Type: OTHER

itch

itch the sole of the foot

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KY20242235jiangwen

OTHER

Sponsor Role: lead

Responsible Party

KY20242235jiangwen

head of department

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Hu

Role: CONTACT

304517021@qq.com

+86+15399059833

Other Identifiers

KY20242235jiangwen

Identifier Type: -

Identifier Source: org_study_id