An observational study in Minimally Conscious State and Vegetative State, sponsored by Hangzhou Normal University. Completed at 1 site in China. Open to participants aged 27 Years to 77 Years. Per ClinicalTrials.gov, last updated 2018-04-25.
Sponsored by Hangzhou Normal University · Observational
This study is aimed to detect the initiation of swallowing act in DOC patients, to find if it is a good item as a stimulus and to detect the relationship between the initiation of swallowing act and the prognosis of DOC patients.
Studies suggest that the initiation and patterning of swallowing of the pharyngeal phase is also under active cortical control for both spontaneous as well as volitional swallowing in awake humans and non-human primates. A recent study found that most patients of disorders of consciousness (DOC) would recover their swallowing ability quickly. And there is no study about detecting the initiation of swallowing act in DOC patients. This study is aimed to detect the initiation of swallowing act in DOC patients, to find if it is a good item as a stimulus and to detect the relationship between the initiation of swallowing act and the prognosis of DOC patients. DOC patients were recruited (standard diagnosis procedure is 4 times CRS-R testing within 2 weeks). The different four stimuli were as follows: 1) One command (as recommended in CRS-R) which was "open your mouth". 2) Put a spoon in front of the patient's mouth without a command. 3) One command with a spoon in front of the mouth, the command is "there is a spoon and open your mouth". 4) One command with a spoon full of water in front of the mouth, the command is "there is a spoon with water and open your mouth". We presented these stimuli orderly in front of the patient's mouth and presented any one of them over 4 trials at 15 second intervals.
88 studies on the registry are indexed under Persistent Vegetative State; 20 are open to participants now.
This study's enrollment of 24 is below the median of 80 across 31 observational studies indexed under Persistent Vegetative State.
Browse Persistent Vegetative State studies →Hangzhou Normal University is the lead sponsor of 22 studies on the registry; 1 is open to participants now.
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patients with disorders of consciousness
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Exclusion Criteria:
Patients with disorders of consciousness from several brain injury, assessed by Coma Recovery Scale-Revised (CRS-R), have been clinically classified into coma, unresponsive wakefulness syndrome and minimally conscious state.
Diagnostic Test: Coma Recovery Scale-Revised
Patients with disorders of consciousness were assessed by Coma Recovery Scale-Revised (CRS-R). In addition, we selected four stimuli: 1) only a command (as recommended in CRS-R), which was "open your mouth"; 2) only a spoon without a command; 3) a spoon and a command, the command was "there is a spoon and open your mouth"; 4) a spoon with water and a command, the command was "there is a spoon with water and open your mouth". In brief, we presented these stimuli orderly in front of the patient's mouth and presented any one of them over 4 trials at 15 second intervals.
Coma Recovery Scale-Revised （CRS-R）
examine the prognostic value of patients, longitudinal behavioral assessments were repeatedly conducted by means of the CRS-R 6-month later
Time frame: Six month later
Plan to share: Yes
Ran from Jun 2016 to primary completion in Mar 2018, 21 months.
Of 16 observational studies under Persistent Vegetative State, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 60. This study's 21 months is below that.
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This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Hangzhou Normal University