Advancing Assessment for Disorders of Consciousness
ConditionDisorders of Consciousness
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorXuanwu Hospital, Beijing
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients with disorders of consciousness
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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 onsetOther outcomes
1
Coma Recovery Scale-Revised (CRS-R) at 1, 3, 6 and 12 months.
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.
Time frame
12 months of disorders of consciousness onset2
Glasgow Outcome Scale-Extended (GOSE) at 1, 3, 6 and 12 months.
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).
Time frame
12 months of disorders of consciousness onsetSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: