Advancing Assessment for Disorders of Consciousness

Not yet recruiting

• Conditions: Disorders of Consciousness

• Registration Number: NCT07180589
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

Over the past two decades, major progress has been made in detecting, predicting and promoting recovery of consciousness in patients with disorders of consciousness (DOC) caused by severe brain injuries. This study will aim to establish innovative standards and intelligent diagnostic system based on multi-source heterogeneous information including clinical signs, advanced neuroimaging and electrophysiological techniques, thus raising hope for more accurate diagnosis and prognosis.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-25
• Study First Submitted QC: 2025-09-16
• Last Update Submitted: 2025-09-16
• Study First Posted: 2025-09-18
• Last Update Posted: 2025-09-18
• Study Start: 2025-09-25
• Primary Completion: 2028-04-30
• Study Completion: 2028-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• age range: 18-80 years old; brain injury caused by various reasons, confirmed by clinical physical and chemical, neuroimaging (head MRI or CT) examination; Glasgow Coma Score (GCS)<12 points; modified Rankin Scale (mRS) score before the onset of the disease was less than 2 points; obtain informed consent from the patient's legal representative.

Exclusion Criteria

• patients with significant skull defects; contraindications for electromagnetic related examinations and treatments, including the presence of metal materials in the body (such as pacemakers, dentures, steel nails, cochlear implants, etc.); patients with a history of epilepsy and clinical indications of epileptic seizures or epileptic discharges on electroencephalogram (EEG); women who are pregnant, breastfeeding, or have a positive pregnancy test upon admission; patients with an estimated survival period of less than 3 months due to various serious illnesses.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modified Rankin scale (mRS) at 1, 3, 6 and 12 months.	12 months of disorders of consciousness onset	Seven grades are set for scores of each item: 0-point (no disability), 1-point (no significant disability), 2-point (slight disability), 3-point (moderate disability), 4-point (moderate severe disability), 5-point (severe disability), and 6-point (death).

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing Municipality, China