The Initiation of Swallowing Can Indicate the Prognosis of DOC

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Initiation of Swallowing Can Indicate the Prognosis of Disorders of Consciousness

Conditions
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Minimally Conscious State, Vegetative State

Intervention / Treatment
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* Diagnostic Test: Coma Recovery Scale-Revised


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 18 years no administration of central nervous system stimulant, neuro-muscular blocking agents, or sedative within the prior 24 hours a diagnosis of VS or MCS-, based on the behavioral assessment of standardized CRS-R periods of eye opening (indicating preserved sleep-wake cycles). Exclusion Criteria: documented history of prior brain injury premorbid illness resulting in documented functional disabilities up to time of the injury acute illness (e.g., pyrexia, pneumonia, diarrhea) receiving hyperbaric oxygen treatments within 2 hours fracture of the mandible.

Ages Eligible for Study
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Minimum Age: 27 Years
Maximum Age: 77 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with disorders of consciousness<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Six month later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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disorders of consciousness, swallowing, prognosis prediction, minimally conscious state, vegetative state