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The Initiation of Swallowing Can Indicate the Prognosis of DOC

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03508336
Enrollment
24
Registered
2018-04-25
Start date
2016-06-03
Completion date
2018-04-12
Last updated
2018-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Minimally Conscious State, Vegetative State

Keywords

disorders of consciousness, swallowing, prognosis prediction, minimally conscious state, vegetative state

Brief summary

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

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.

Interventions

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.

Sponsors

Hangzhou Normal University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
27 Years to 77 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Coma Recovery Scale-Revised (CRS-R)Six month laterexamine the prognostic value of patients, longitudinal behavioral assessments were repeatedly conducted by means of the CRS-R 6-month later

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026