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The predictive and awakening-promoting value of acoustic stimulation closed-loop regulatory system in patients with acute consciousness disorder: a randomized controlled study

The predictive and awakening-promoting value of acoustic stimulation closed-loop regulatory system in patients with acute consciousness disorder: a randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108372
Enrollment
Unknown
Registered
2025-08-28
Start date
2025-08-31
Completion date
Unknown
Last updated
2025-09-01

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

Conditions

Disturbance of consciousness

Interventions

Stimulated group:Closed loop acoustic stimulation
Control group:None

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >=18 years old; 2. Patients with a clear diagnosis of acute consciousness disorder, with a clear cause, can include brain trauma, acute ischemic stroke, acute hemorrhagic stroke, encephalitis, ischemic hypoxic encephalopathy, postoperative PCR, etc.; 3. Glasgow ComaScale (GCS) score in severe DOC <=8 points; 4. The interval between the start time of severe DOC and the time of closed-loop EEG regulation examination or stimulation is 3-28 days, and EEG is performed, and the patient is still DoC at the time of monitoring; 5. Patients or their families are able to cooperate, understand and have the ability to complete this clinical trial.

Exclusion criteria

Exclusion criteria: 1. Death or return to consciousness within 48 hours of onset; 2. Serious comorbid diseases, such as acute myocardial infarction, heart failure, major bleeding, advanced cancer, severe liver and kidney insufficiency, etc., resulting in limited survival time; 3. Shock (systolic blood pressure < 80 mmHg); 4. Those who have impaired consciousness, dementia, or mRS score greater than 2 points before the onset of the disease; 5. Those whose family members gave up life support treatment for some reason before brain death; or patients who are lost to follow-up; 6. Contraindications to head CT/MRI examination (such as metal implants, etc.); 7. Those who have atresia syndrome or eyelid movement injury and are conscious (such as ptosis); 8. Those with severe neurodegenerative or mental illness; 9. Use of sedative drugs or anti-seizure drugs before examination or stimulation therapy.

Design outcomes

Primary

MeasureTime frame
Degree of change in consciousness;

Countries

China

Contacts

Public ContactMingsu Liu

Zhongshan Hospital, Fudan University

liu.mingsu@zs-hospital.sh.cn+86 183 2300 8867

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026