Disorders of Consciousness
Conditions
Keywords
Disorders of consciousness, Prognostication
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.
Interventions
None listed
Sponsors
Xuanwu Hospital, Beijing
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Coma Recovery Scale-Revised (CRS-R) at 1, 3, 6 and 12 months. | 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. | 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). |
Countries
China
Contacts
Primary ContactYan Zhang, MD, PhD
Backup ContactGang Liu, MD, PhD
Outcome results
None listed