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

KY20242235jiangwen

Status: Not yet enrolling

Conditions: Disorders of Consciousness Due to Severe Brain Injury

Treatments: Other: itch; Other: thermal stimulation

Study type: Observational

Funder types: Other

Identifiers

NCT06922864

KY20242235jiangwen

Details and patient eligibility

About

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).

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

36 participants in 2 patient groups

good outcome

not good outcome