Advancing Assessment for Disorders of Consciousness

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.

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Key information

Conditions

Disorders of Consciousness Consciousness Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Modified Rankin scale (mRS) at 1, 3, 6 and 12 months.

Time frame: 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).

Other outcomes

Coma Recovery Scale-Revised (CRS-R) at 1, 3, 6 and 12 months.

Time frame: 12 months of disorders of consciousness onset

The CRS-R scale consists of 23 hierarchically organized items divided into five functional subscales (auditory, visual, motor, oromotor/ verbal, communication) and an arousal scale. The sum of subscale values forms the total CRS-R score ranging between 0 and 23, with low values reflecting reflexive behavior and higher values indicating cognitively mediated behavior.
Glasgow Outcome Scale-Extended (GOSE) at 1, 3, 6 and 12 months.

Time frame: 12 months of disorders of consciousness onset

Eight grades are set for scores of each item: 1-point (dead), 2-point (vegetative state), 3-point (lower severe disability), 4-point (upper severe disability), 5-point (lower moderate disability), 6-point (upper moderate disability), 7-point (lower good recovery), and 8-point (upper good recovery).

Study contacts

Contact information is provided by the study sponsor or research team.

Gang Liu, MD, PhD

CONTACT

[email protected]

+8615001073140

Yan Zhang, MD, PhD

CONTACT

[email protected]

+861083198475

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study title

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

Acronym: AADOC

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: Sep 18, 2025
Registry last updated: Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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