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Study on the assessment of patients with disorders of consciousness in the ICU using combined EEG and fNIRS technology

Assessment of patients with disorders of consciousness in the ICU using combined EEG and fNIRS technology

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600120132
Enrollment
Unknown
Registered
2026-03-10
Start date
2026-03-10
Completion date
Unknown
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorders of Consciousness

Interventions

Sponsors

Huashan Hospital Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

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

MeasureTime frame
Electroencephalography;Functional Near-Infrared Spectroscopy signals;

Secondary

MeasureTime frame
Coma Recovery Scale-Revisedscores at 3 and 6 months post-enrollment;

Countries

China

Contacts

Public ContactDeng Shuixiang

Huashan Hospital Fudan University

Shuixiang2@126.com+86 137 9532 8612

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026