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Not yet recruiting NCT07180589

Advancing Assessment for Disorders of Consciousness

Observational Disorders of Consciousness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Disorders of Consciousness. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Advancing Assessment for Disorders of Consciousness (AADOC): Innovative Standards and Intelligent Diagnostic System Based on Multi-source Heterogeneous Information

Overview

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.

Primary outcome measures

  • Modified Rankin scale (mRS) at 1, 3, 6 and 12 months. [Time frame: 12 months of disorders of consciousness onset]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

China · 1 center
  • Xuanwu Hospital, Capital Medical University — Beijing

Identifiers

NCT: NCT07180589 · 2024YFC3606901

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗