Clinical Trials Directory

Trials / Completed

CompletedNCT03508336

The Initiation of Swallowing Can Indicate the Prognosis of DOC

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

Status
Completed
Phase
Study type
Observational
Enrollment
24 (actual)
Sponsor
Hangzhou Normal University · Academic / Other
Sex
All
Age
27 Years – 77 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTComa Recovery Scale-RevisedPatients 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.

Timeline

Start date
2016-06-03
Primary completion
2018-03-24
Completion
2018-04-12
First posted
2018-04-25
Last updated
2018-04-25

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT03508336. Inclusion in this directory is not an endorsement.