Disorders of Consciousness
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria for Patient Group: 1. Aged 18–80 years, of any sex. 2. ICU inpatients with disorders of consciousness (GCS <= 9) resulting from various types of brain injury (e.g., cerebral infarction, cerebral haemorrhage, traumatic brain injury, hypoxic-ischaemic encephalopathy) according to the European Academy of Neurology diagnostic criteria. 3. Relatively stable vital signs. 4. Written informed consent provided by the patient's legal representative. Inclusion Criteria for Healthy Control Group: 1. Aged 18–80 years, of any sex. Age and sex-matched to the patient group. 2. No known history of central or peripheral nervous system diseases or psychiatric disorders. 3. No history of severe systemic diseases involving the heart, liver, lungs, or kidneys. 4. Right-handed. 5. Written informed consent provided by the participant.
Exclusion criteria
Exclusion criteria: Exclusion Criteria for Patient Group: 1. Previous history of severe neurological or psychiatric disorders resulting in functional impairment. 2. Presence of open head injuries, extensive skull defects, or severe scalp oedema that precludes the placement of EEG electrodes or fNIRS optodes. 3. Current state of deep sedation for non-therapeutic purposes (e.g., use of high-dose barbiturates and sedatives). 4. Presence of epileptic seizures. 5. Hearing impairment. 6. Refusal to participate or withdrawal of consent by the legal representative. 7. Mismatch Negativity (MMN) amplitude in auditory evoked potential testing <0.6µV Exclusion Criteria for Healthy Control Group: 1. Scalp injuries or skin diseases that preclude the placement of electrodes or optodes. 2. Pregnant or lactating women. 3. Current participation in other clinical studies. 4. Inability to understand and cooperate with the research procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Electroencephalography;Functional Near-Infrared Spectroscopy signals; | — |
Secondary
| Measure | Time frame |
|---|---|
| Coma Recovery Scale-Revisedscores at 3 and 6 months post-enrollment; | — |
Countries
China
Contacts
Huashan Hospital Fudan University