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Exploring covert awareness in patients with prolonged disorders of consciousness using fMRI imaging based on imagined swallowing task: a case-control study

Exploring covert awareness in patients with prolonged disorders of consciousness using fMRI imaging based on imagined swallowing task: a case-control study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500109216
Enrollment
Unknown
Registered
2025-09-15
Start date
2025-09-15
Completion date
Unknown
Last updated
2025-09-22

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

Conditions

Disorders of consciousness

Interventions

pDOC group:None

Sponsors

The second people's hospital of Shenzhen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: pDOC group: (1) Obtained consent from the subject's guardian, joined the study and signed the informed consent form;(2) Patients with chronic disturbance of consciousness;(3) Patients with stable vital signs (stable breathing and hemodynamics), and neurological symptoms no longer progressed;(4) Patients aged 18-85 years;(5) No central stimulants; no sedatives or neuromuscular blockers;(6) No history of epilepsy or other serious neurological and systemic diseases;(7) No contraindications for fMRI examination. HC group: (1) Persons with personal behavioral capacity are willing to join the study and sign the informed consent form;(2) Persons without neurological or psychiatric disorders;(3) No organic or functional swallowing disorders;(4) There are no other diseases or dysfunction that may seriously affect the study results.

Exclusion criteria

Exclusion criteria: pDOC group: (1) the condition of the primary disease still has significant changes, which is life-threatening and unstable;(2) the history of the primary disease causing disturbance of consciousness exceeds 1 year;(3) there are contraindications for fMRI;(4) brain structure defect; complete loss of hearing function; oral structure defect and other conditions that seriously affect swallowing function. HC group: (1) those who refused to sign informed consent;(2) those who had various diseases or dysfunction that seriously affected the study results;(3) those who took sedative drugs and neuromuscular blockers before and after the study;(4) those who had contraindications for fMRI examination.

Design outcomes

Primary

MeasureTime frame
Coma Recovery Scale-Revisions(CRS-R) score ;Simple Swallow Assessment Result;Changes in activity and functional networks of brain areas of interest on fMRI;

Countries

China

Contacts

Public ContactJingpu Zhao

The second people's hospital of Shenzhen

zjp139569@126.com+86 180 1870 7809

Outcome results

None listed

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