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A Study on the Efficacy of Auditory Stimulation for Patients with DOC and Its Neural Mechanisms

A Study on the Efficacy of Auditory Stimulation for Patients with DOC and Its Neural Mechanisms

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127279
Enrollment
Unknown
Registered
2026-06-29
Start date
2026-06-30
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

Disorder of consciousness

Interventions

FAST Group:The FASTFamiliar Auditory Sensory TrainingFAST protocol is adopted for auditory stimulation treatment. The patient's familiar person tells the patient's story from at least one year ago in
Control group:The placebo group regimen was adopted silently
Natural Sound Test Group:Listen to the chirping of birds, the sound of waves, etc

Sponsors

Beijing Bo'ai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Patient (1) A patient who meets the PDOC criteria of the European Society of Neurology Guidelines (more than 4 weeks after brain injury); 2. Patient (2) was diagnosed as UVS/VS or MCS after five CRS-R evaluations within one week; 3. Patient (3) has a clear cause and stable vital signs; 4. Patient (4) Age: 18-85 years old; 5. Patient (5) right-handed; 6. Patient (6) has not participated in any other clinical studies in the past three months; 7. The patient (7) signs an informed consent form signed by a family member or an authorized person; 8. Healthy individuals (1) Age matching the patient, ranging from 18 to 85 years old, with no gender restrictions; 9. Healthy individuals (2) In good health condition, with no history of diseases related to the circulatory system, nervous system, mental disorders, or metabolic disorders; 10. Healthy individuals (3) have full capacity for civil conduct; 11. Healthy individuals (4) Trial participants voluntarily sign informed consent forms;

Exclusion criteria

Exclusion criteria: 1. Patient (1) The patient's condition is unstable, with severe and uncontrolled complications in the respiratory or circulatory system. During the acute stage of the disease, the patient is in status epilepticus, has multiple traumas, limb fractures, and extensive skin defects. Those whose condition continues to worsen and whose active cerebral hemorrhage has not yet been controlled; 2. Patient (2) suffers from mental illness, drug abuse or long-term alcohol addiction; 3. The patient (3) has intracranial tumors, intracranial infections, or any clinically significant or unstable medical diseases; 4. Patient (4) Infection; 5. Patients (5) who are unable to collect fNIRS data; 6. Patient (6) with severe hearing impairment; 7. The patient (7) has an extremely high level of musical literacy or has previously engaged in music-related work; 8. Healthy individuals (1) with a history of atrial fibrillation, heart surgery or betaloc medication; 9. Healthy individuals (2) with a history of mental illness, drug abuse, or drug dependence; 10. Healthy individuals (3) Women with positive pregnancy test results or those who are breastfeeding; 11. Healthy individuals (4) who have consumed excessive amounts of tea, coffee or caffeinated beverages (more than 8 cups per day, each cup 250mL) in the past six months; Those who have consumed any beverage or food containing caffeine (such as coffee, strong tea, chocolate, etc.) within 48 hours before the start of the test; 12. Healthy individuals (5) who are unable to collect fNIRS data; 13. Healthy individuals (6) with hearing impairments; 14. Healthy individuals (7) possess extremely high musical literacy or have previously engaged in music-related work;

Design outcomes

Primary

MeasureTime frame
Functional near-infrared spectroscopy;

Secondary

MeasureTime frame
Coma Recovery Scale-Revised(CRS-R);Glasgow Coma Scale(GCS);Glasgow Outcome Scale Extended(GOS-E);Demographic information indicators;

Countries

China

Contacts

Public ContactZhang Jinqin

Beijing Bo'ai Hospital

m13051384533@163.com+86 10 87020430

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026