Advancing Assessment for Disorders of Consciousness

N/ANot Yet RecruitingNCT07180589

Xuanwu Hospital, Beijing200 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Disorders of Consciousness

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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

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).

Time frame: 12 months of disorders of consciousness onset

Central Contacts

Yan Zhang, MD, PhD

CONTACT

+861083198475 zhangylq@sina.com

Gang Liu, MD, PhD

CONTACT

+8615001073140 liugangqingyi@sina.com

Data from ClinicalTrials.gov

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